Saturday, January 14, 2017

Advance Care Planning Volunteer Certification?


The Colorado Health Foundation has recently funded a host of proposals around our state to increase advance care planning (ACP) in Colorado.  The proposals I’ve heard about seem quite innovative.  Many, including ours, are utilizing a volunteer workforce to implement the ACP.  Some of us at the University of Colorado, in partnership with our friends at the Denver Hospice, are working on a project to create a “certification program” for advance care planning volunteers.  I keep thinking of it as being similar logistically to CPR certification.  Obviously, that analogy is not perfect – ACP volunteers don’t have to do chest compressions…and CPR volunteers don’t have to have skills in communication.  However, the idea of a program where someone can learn the basics, practice, get feedback, and become certified is really exciting to me. 

Through our development, we’ve begun to wonder and question our assumptions about what a volunteer can do.  We are hoping to get some input.  We’ve put together a very short, 7-item survey to get people’s perceptions on what kinds of skills an ACP “certified” volunteer should have.  This is not research – we’re not planning on publishing this survey.  Really, we just want to ask people broadly what their thoughts are as we go forward.  The survey is anonymous and should take 3-5 minutes. Thank you!!   https://www.surveymonkey.com/r/328GVQL

by: Dan Matlock
Read more »

Wednesday, January 4, 2017

How to Incorporate the Results of a New Trial of Palliative Care in Lung and GI Cancers



by: Eric Widera (@ewidera)

A little over 6 years ago, Jennifer Temel and colleagues published a trial of patients with newly diagnosed metastatic non–small-cell lung cancer showing that early integrated palliative care significantly improved quality of life and other measures like symptom control.   Now we have a follow-up study published this week evaluating early integrated palliative care for patients with newly diagnosed incurable lung or non-colon GI cancers.

A brief overview of the study

350 patients with newly diagnosed incurable cancers were randomized to early palliative care integrated with oncology care compared with usual oncology care.    The patients had to be within 8 weeks of a diagnosis of incurable lung or noncolorectal GI (pancreatic, esophageal, gastric, or hepatobiliary) cancer.   They also couldn’t have a history of therapy for metastatic disease, and had to have a reliatively good functional status (ECOG 0-2).

Those who got palliative care in addition to usual care met with a member of the outpatient palliative care team (a physician or advance practice nurse) within 4 weeks of enrollment and at least once per month until death (or via telephone when an in-person visit was not possible).  For patients who were admitted to their hospital, the inpatient PC team observed them throughout their hospitalization.

The Results

The first interesting result is that there was a fair amount of palliative care going on in the usual group, as the palliative care team meet with 34% of the usual care patients by week 24 weeks.    So it is possible that the effect of the palliative care is greater than what was described below, as many in the control group go the study intervention.

The second interesting finding is that the group randomized to palliative care reported an increase in quality of life scores at 12 weeks compared with usual care patients who reported a decrease.   This difference became statistically significant at 24 weeks.

Other measures such as PHQ-9, HADS-Depression, and HADS-Anxiety scores did't differ significantly between study groups.   However, more intervention patients reported that they had discussed their end-of-life wishes with their oncologist compared with usual care patients (30% vs 15%).

Lastly, an exploratory subgroup analysis showed that there may be a difference differences in study outcomes between patients with lung and GI cancers.   However, take it with a grain of salt, given that there was a lot of cross-over to palliative care and it was not a primary outcome of the study.

The Take-away

It's been a very productive year in regards to palliative care randomized control trials, including these that we have covered on GeriPal:

Notably, the first article in this group was not just a negative trial, but one that showed that maybe the group that got the intervention had greater PTSD symptoms.  All of these trials, both positive and negative, have merit as they help to define how and to whom we should be delivering palliative care.  Putting them together, the picture starts to add weight to an argument on how palliative care should be provided (lifted from an editorial I wrote along with Preeti Malani that discussed the negative ICU trial):
"...this study provides a cautionary tale that care delivered by specialists may not be effective when following a highly structured study protocol that solely aims to provide informational support with little regard to what makes this process meaningful to many patients, families, and clinicians: frequent and longitudinal follow-up, close involvement with the primary clinical team, and a focus on relief of physical and psychosocial distress."


Read more »

Friday, December 30, 2016

Descriptive terms for older people: older is in and elderly is out



"Never be the first to use a new descriptive term for older people nor the last to give up an old one." 
This is the advice given by Laura Morrison and colleagues in the discussion section of a fascinating new study published in JAGS this week.  The authors looked at how "older people" are described in the English-language medical literature from 1950 to 2015. Specifically they looked at the use of the terms “geriatric,” “aged,” “old,” “older,” and “elderly” in Pubmed.

Here is what they found:
  • We liked using the term “aged” in publications before 1961, but "aged" quickly lost its appeal over the next decade
  • “Geriatric” became more common from 1955 to 1976 but again fell out of favor over the last couple decades 
  • “Elderly” peaked around the time of George Michael's release of "Father Figure" (I'm not sure if there was a connection between the two)
  • “Older" hit its low point in 1962 but boomed in use with the boomers, and is now our most popular term accounting for 55% of references

Alex Smith wrote about this topic in 2012, which garnered quite a bit of comments when he also advocated for the word senior (which was surprisingly lacking in this current study).   In the end, there isn't really a right answer as language continues to evolve.

So it I'll end this post with a quote from the article that should give us pause for advocating for any particular word to passionately:
"The meanings of many words shift with time. Unfortunately, of the categories that linguists use to classify such semantic changes, “degeneration (pejoration)”—the acquisition of more-negative or more-disparaging connotations with time—best describes the changes of many words pertaining to older people."

 by: Eric Widera (@ewidera)



Read more »

Wednesday, December 21, 2016

Palliative care: the long view

Balfour Mount


by: Alex Smith, @AlexSmithMD

In 1976, Balfour Mount published a landmark description of the first palliative care unit, in the Royal Victoria Hospital, Montreal.  He opens with this quote from John Hinton's Dying:
We emerge deserving of little credit; we who are capable of ignoring the conditions which make muted people suffer.  The dissatisfied dead cannot noise abroad the negligence they have experienced.
Bal Mount goes on to decry decreases in physicians and nursing visits as death becomes imminent, longer response times to care for dying patients than those expected to recover, and isolation, distrust, and suspicion that arises from lack of communication between patients, family members, nurses, and physicians.

How far has palliative care come as a field in the intervening 40 years?  What can we say about palliative care and how it helps or does not help people?  How well have we advanced care for those seriously ill people whose voices are "muted," and the "dissatisfied dead?"

Off the top of my head, I'd argue that we have made 3 major advances as a field, and we have 3 major challenges ahead of us.

Advances

  1. Palliative care is now in more hospitals than just "the Royal Vic."  At last count 67% of US hospitals had a multidisciplinary palliative care team.  
  2. The focus has shifted from caring for the "dying" to caring for the "seriously ill."  This change is due to several factors, including challenges and uncertainty in prognostication, lack of clarity about when someone is "dying" (we're all dying in some sense), and the recognition that palliative care is better when it's delivered early, when most people don't consider themselves to be "dying" (yet).
  3. The evidence base has improved dramatically.  A terrific recent systematic review and meta-analysis by Dio Kavalieratos in JAMA found that palliative care interventions improved quality of life and symptom burden without shortening survival.
Challenges
  1. Outpatient and community palliative care.  While palliative care has grown by leaps and bounds on the inpatient setting, outpatient and home-based services lag behind.  This gap exists despite the bulk of the trials in the Kavalieratos review coming from the outpatient, rather than inpatient setting.  
  2. Resource poor countries lag far behind wealthy nations in developing palliative care programs.  This poorly named "Quality of Death" index ranks countries by their attention to palliative care, finding that wealthy nations are clustered near the top.  Exceptions are noted, including Panama and Mongolia, resource poor nations that are building palliative care into the healthcare infrastructure, and Russia, a wealthy nation that ranks near the bottom of the list.
  3. Staying humble.  We live in uncertain times.  We are continually surprised by unintended consequences, mis-reading the moment, and challenges from unexpected places.  The opioid epidemic is real.  Some few hospices do prioritize profit too highly.  Trump is considering Sarah Palin to head the VA.  
In these uncertain times, we must stay humble and keep the focus on what matters most: our mission. 

We care for people whose voices are muted.  We care for woman with dementia in the nursing home who can't speak for herself.  We care for the veteran who has been living on the streets, struggling with PTSD and alcohol addiction, and now has throat cancer.  We care for the child who says he wants to stop chemotherapy and we care for his parents.   

To stay the course of progress, we must keep the focus on making their voices heard.
Read more »

Monday, December 19, 2016

Rejecting Neutrality - Reducing Burdensome Hospitalizations For Nursing Home Residents




Nursing home residents are often sent to the hospital for care that often offers little hope of improving quality of life or changing the course of illness. Some facilities though seem to do much better in preventing these "potentially burdensome hospitalizations". We discuss with Andrew Cohen, the lead author of a recent JAMA IM paper on this subject, to learn a little about what is in the secret sauce of these exceptional nursing homes.

Listen to the podcast here, see the transcript below.

by: Alex Smith, @alexsmithMD


Links to articles discussed:

Main article:

Cohen, Andrew B., M. Tish Knobf, and Terri R. Fried. "Avoiding Hospitalizations From Nursing Homes for Potentially Burdensome Care: Results of a Qualitative Study." JAMA Internal Medicine (2016).

Other interesting/related articles mentioned:

Sulmasy DP, Snyder L. Substituted Interests and Best JudgmentsAn Integrated Model of Surrogate Decision Making. JAMA. 2010;304(17):1946-1947. doi:10.1001/jama.2010.1595

Dzeng E, Colaianni A, Roland M, Chander G, Smith TJ, Kelly MP, Barclay S, Levine D. Influence of Institutional Culture and Policies on Do-Not-Resuscitate Decision Making at the End of Life. JAMA Intern Med. 2015;175(5):812-819. doi:10.1001/jamainternmed.2015.0295

Hanson, Laura C., et al. "Effect of the Goals of Care Intervention for Advanced Dementia: A Randomized Clinical Trial." JAMA Internal Medicine (2016).


---

Click one of the links below to follow GeriPal Podcasts on:
---

Transcript

Eric: Welcome to the GeriPal podcast. This is Eric Widera.

Alex: This is Alex Smith.

Ken: This is Ken Covinsky.

Eric: Alex, we have another guest with us today.

Alex: We have a guest on the line all the way from New Haven, Connecticut. We have Andrew Cohen, who is a physician-researcher in the section of Geriatrics at Yale School of Medicine. Andrew, welcome to the GeriPal podcast.

Andrew: Great to be here.

Eric: We start off with all these podcasts by the guest requesting a song from Alex.

Alex: Yes, so, we've heard that you like the Simon & Garfunkel. Is that right, Andrew?

Andrew: I do. I'm a big fan.

Alex: We have a classic here, “The Boxer”.

Alex sings “The Boxer” by Simon and Garfunkel.

Alex: Ken, how do we transition from The Boxer to the topic of today?

Ken: You know, The Boxer's a classic song about a journey and a lot of times the journey of life does end in the nursing home.

Alex: Oh, very good. Andrew, do you want to tell us a little bit about ... what, you know, this is a study and we'll have a link to it below, that you published in the journal, JAMA Internal Medicine, about avoiding hospitalizations for nursing homes for potentially burdensome care. Results of a qualitative study. I'd like you to say a little bit about why you were interested in doing this. What on earth possessed you to be interested about hospitalizations for nursing homes residents? There's not a problem there, is there?

Laughter
Andrew: Not at all, maybe about, you know, almost a million times a year, I think. I got interested in this when I was a clinical fellow a couple of years ago. Here we take call on weeknights and for weekends and it's pretty busy. We cover eight or nine facilities and we get, sometimes, 20 are 30 calls a day.

What became clear pretty early on was that staff at different nursing homes were acting very differently. Some nursing homes were calling very regularly to advocate for hospitalizing patients and others were almost never calling.

I got interested in the differences in behavior between different facilities and wanted to know more about how staff behaved and approached the difficult decisions about hospitalizing a frail older patients.

Eric: For this study, it looks like you went to eight different nursing homes? Four of those were those that had less hospitalizations and four were those who had high use of hospitalizations for their residents. Is that right?

Andrew: Yeah. Yes, so this is a strategy that's been used by a bunch of different investigators. We were actually directly inspired by one of Joe Ouslander's papers looking at potentially avoidable hospitalizations from nursing homes in which he looked at high and low hospitalizing facilities in Georgia.

We did the same in Connecticut. We were, specifically, interested in a particular type of hospitalization from the nursing home. One that we call a potentially burdensome hospitalization in which the benefits of hospitalization are likely to be very low. There's a small chance of prolonging life or improving quality of life, but the hospitalization, itself, risks very significant burdens to the patient.

We looked at high and low hospitalizing facilities and wanted to know about ... wanted to whether there were differences in how staff approached this type of hospitalization.

Ken: If I'm a family member, one thing that might confuse people is my loved one is in a nursing home and they're sick. Don't I want them in the hospital? Isn't the hospital the place where sick people go and where they can get better care? Why would I want my loved one not to go to the hospital? Let's assume that I, actually, do want them to live for a while. They're not like a hospice end-of-life patient.

Andrew: Yeah, that's a good question and I think it’s one that... I think, families often perceive the hospital as being a safer place then the nursing home. Then some ways, I think, don't necessarily perceive the nursing home as a place that can even provide sophisticated medical care. They think of it as a place the person lives and not where they would get treated if they were sick.

On the other hand, we know from a very robust body of literature about how dangerous a place the hospital can be for an older person. Those risks start seeming less and less desirable when the hospitalization itself, has very little chance of making the person live longer or feel better.

Ken: Interesting, so you're saying that families may misperceive the chance that a hospital's actually going to make their loved one better. They might think they're going to get better in the hospital when they won't and they might not understand how much worse they could get in the hospital.

Andrew: Yeah, I think, that's a very hard thing for families to rack their minds around.

Alex: It sounds like you were also suggesting from your research, or your research suggested, part of the reason that you did this study, that it's not just the families that are coming up with these ideas. That there could be something structural about the nursing home facility or about the way that hospitalization is presented to these families.

Andrew: Yeah, I think, we think a lot about how tough it is for families to make the decision not to hospitalize a loved one. I think it's also very challenging for providers in nursing homes to make that decision. Especially if the discussion is happening by phone or on the weekend.

One of the providers that we talked to in our study, talked about how difficult it was to be isolated from other providers and specialists and the resources that the hospital had to offer. Then told us that often times the easier and safer thing just to hospitalize the patient.

We did find that there were different approaches despite these barriers in nursing facilities that had lower hospitalization rates. Broadly speaking that staff and facilities that were low hospitalizing were more willing to really engage in case by case decision making with patients -really elicit their goals and priorities and really engage with them to try to figure out if hospitalization was really in accordance with those goals.

Eric: I know you had limited space in your research letter to describe the robust rich qualitative findings that I'm sure you had. Did liability come up? I worried about being sued or nursing home worried about being sued.

Andrew: Yes, it came up in many of the interviews and it's certainly been mentioned in previous work on this subject. It didn't come up in a consistent way even at the same facility, so there were people that told us that hospitalizations would occur out of fear of lawsuits, which is perhaps what you might expect. There were other people who told us that they had a fatalistic approach towards being sued. They thought that nursing homes had a target painted on their back as it was and that there was nothing they could do to prevent being sued, so it didn't really affect their decisions.

Eric: That's interesting.

Ken: So Andrew, one of the things ... You have something intriguing in the article that challenges some notions we were taught about patient-centered decision making. Which is, a classic model is you ask a family member what they want. Here you present a model where the nursing homes that have low hospitalizations have a model of redirecting, where the family members say what they want and if the nursing home doesn't think that's in the patient's best interest ... Yeah, I think, you even used the word "talked them out of it" or maybe the staff used the word "talked them out of it". It's not a classic word in shared decision making.

Andrew: I think, it's important to say that pretty much to the person, the people we interviewed said that decisions about hospitalization were ultimately the responsibility of patients, or in most cases, their surrogate decision makers.

What participants at the lower hospitalizing facilities had told us is that they started conversations by really eliciting patients goals and told us that this was really difficult to do -that it took a lot of time and a lot of work.

That sometimes led them when they saw family members making decisions about hospitalization that didn't seem to be in accordance with those goals, to speak up and to say that they disagreed with those decisions.

Ken: So, you can argue with actually even a deeper level of shared decision making where you actually don't just take what's said literally, but you actually try to go into deeper meaning where you recognize that what's said literally doesn't actually represent their values. It represents a lack of information and you actually try to make sure they're fully informed about their decisions.

Andrew: Yeah, that's right. One of the things that we heard from participants in this study is something that certainly rings true for me in my clinical experiences. We often see patients needing to be hospitalized a bunch of times before families are able to see that there's not improvement and to see the risks outweighing the benefits. I think, what staff members are sometimes doing is using their own experience having seen this, just to explain to families who may not understand the risks and benefits of hospitalization. What those really are and to engage in a deeper level, as you say, of shared decision making, so that the choice that's most in accordance with a patient's goals can be honored.

Eric: Facilities that were the low hospitalizing facilities used more case by case decision making versus default pathways. They tried to change family member's mind versus deferring to their decisions. Like you said, that takes a lot of time.

I'm just thinking when I'm on-call in the nursing home. It's the middle of the night. I have no idea who most of these individuals are. Am I going to take the amount of time which ... for good goals of care discussion would take at least half an hour, if not an hour… in a patient, I know nothing about? How do these facilities do that? How do they handle nights and weekends?

Andrew: I think, that most facilities have trouble with this. In our study, even the more successful facilities raised that as an issue. I think that it's likely to be true that some of this hard work is being done before an acute event arises. You know, that patients who are at risk of having an acute event of the kind where you might think of sending them to the hospital, that providers are talking to them when the sun is up.

I think, the nighttime and weekend problem is a real one and hard to imagine a fix for it without some fundamental structural changes in how nursing homes are staffed.

Eric: I noticed that you did not just interview physicians. You interviewed nurses, facility administrators, social workers, advanced practice clinicians, other individuals. Are there differences between the high utilizers and the low utilizers, as far as, who is helping families make these decisions? Like, the nurse is playing a more active role in helping family members make decisions in the traditional hierarchy where it's the physician or the advanced practice clinician?

Andrew: We saw some differences that, at least in this small study, weren't consistent enough across facilities to really rise above the level of anecdote. We did, for example, see in several of the lower hospitalizing facilities that the social worker had a much more active role and was involved, not just with financial aspects of the patient's stay or completing paperwork, or things like that, but was really involved with goals of care discussions and with talking to families.

We saw, for example, that administrators in some of the lower hospitalizing facilities took a more active role. It would be interesting if we had a larger sample to see whether any consistent pattern emerged.

Alex: What's next for this line of research?

Andrew: We're still thinking about that. There was a, I'm sure you all know, very interesting paper by Laura Hansen a couple of weeks ago in JAMA Internal Medicine that was very thought provoking. I think, that what's interesting about her study is that she used a video decision aid to build on top of existing practices, essentially, in nursing homes.

I think, the next step for us will be to learn some more about whether there are ways to change that behavior, perhaps by communication interventions or other means.

Ken: Do you think there's any role for public health interventions? You know, if your loved one's in a nursing home, think twice before you hospitalize them.

Andrew: That's a great question. What do you think? I'd have to think about that.

Ken: Yeah, I think, one of the things you're getting at here is, I think, I don't know if the public really understands the limits of care. That there's ... the focus on not hospitalizing is actually not a decision often to limit care that's helpful. It's a decision to basically recognize that there's simply limits of what the hospital can do. Is that there's nothing that will be done in the hospital that can't be done in a nursing home. That everything that happens in a hospital beyond that actually can make things worse. I don't know if that's generally understood by families.

Eric: Well, there are a lot of things that can be done in the hospital that can't be done in the nursing home.

Ken: Yeah, I think, you're right, Eric. It's not a one size fits all. You certainly wouldn't say never [hospitalize anybody]. There's certainly cases where somebody in the nursing home should be in the hospital and no benefit. If you have a pneumonia and there's usually, almost nothing that can be done in the hospital that can't be done in a nursing home, so there's a lot of conditions where the hospital probably doesn't help a lot.

Andrew: Yeah, I know that there's been interest in other areas on the nursing home side in educating patients about, in a more positive way, all the things the nursing home really can do. I think, patients still have a really hard time wrapping their minds around that.

The nursing home is a funny place in that it has increasing numbers of patients there for short stays, but a population of long stay residents. Its medical capabilities have become more and more sophisticated, so perhaps making it less about the hospital not being able to do anything and more about all the high-quality care that can be provided in the nursing home.

Eric: If there's one advice for people working in nursing homes that you learned from this study, what would that be?

Andrew: It's that these decisions are really, really hard. There's no way around that. That providers at all levels need to spend a lot of time in a back and forth discussion with patients and their families about these extremely difficult decisions.

Ken: Yeah, well, thank you for pushing this forward. I mean, this is a really important question.

Alex: This is really interesting work. I like this approach. It reminds me of some work that Liz Dang has done looking at differences in hospital cultures. As well as, some work that Daniel Sulmasy has done, as far as, promoting best interest standard for patients that's grounded in an in-depth deep understanding of their interest and not on a superficial level approach to letting them choose among options.

Andrew: I think, is this what he calls “substituted interest”?

Alex: Yes, exactly. Exactly.

Andrew: Yeah.

Eric: We'll put up a link to Dan Sulmasy's substitute interest article on GeriPal. I heard a little strum of a guitar just a second ago, Alex. You want to end us with a little bit more?

Alex plays “The Boxer” by Simon and Garfunkel.


Transcript was edited by Sean Lang-Brown


Read more »

Monday, December 12, 2016

Improving Serious Illness Communication By Developing Formulations




Clinical formulations, something that few of us outside of mental health providers know about, but can be a critical tool in improving communication skills, especially around serious illness.  Learn about them from our special guest, Dani Chammas, in this weeks GeriPal Podcast.  Dani makes the case in this podcast that the single most valuable thing clinicians can do to improve communication is to get into the practice of asking yourself:
  1. What is the core psychological struggle that has this patient or family stuck?
  2. What communication techniques might I use to address that?
  3. How did their response to my intervention change my hypothesis?
  4. Repeat 1-3. 
 I love it when people can distill complicated topics into a couple steps that we can all try. I know I will.  (listen to the podcast here)

 Here are links to a couple papers if you want to learn more:
  • The first article is called "Taking Care of the Hateful Patient" dating all the way back to 1978!  And per Dani, it is “a total classic in psychiatry”.  Short and approachable, it is not specific to "how" to formulate-- but it goes over a 4 of the types of patients that physicians by-and-large tend to dread ("dependent clingers" "entitled demanders" "manipulative help-rejectors" and "self-destructive deniers"); for each they give a brief formulation of what is often going on for such a patient and communication strategies to shoot for.  
  • Here also is a paper of how of how a CBT therapist would formulate.



---

GeriPal Podcasts can be found on:

by: Eric Widera (@ewidera)

Transcript of the Podcast:

Eric: Welcome to the Geripal podcast, this Eric Widera.

Alex: This is Alex Smith.

Eric: Today we have a special guest with us today, Danielle Chamas, who is a psychiatrist and a palliative care doctor and just gave a wonderful talk to our fellows on interesting topic which we will get to. Maybe before that, Dani, we usually ask our guests to give Alex a song that he should sing.

Danielle: I'm going to go with “Free Falling” by Tom Petty.

Alex: Free Falling, great song.

Alex sings “Free Falling” by Tom Petty.

Eric: Dani and I both have our lighters going right now up in the sky.

Danielle: It's a good song choice!

Eric: We just had a really interesting morning core curriculum talk on formulation. Alex have you ever heard of formulation before?

Alex: Drug formulation?

Eric: Apparently not drug formulation, that's what I was thinking initially. Dani what is a formulation and why should we use it in palliative care and geriatrics?

Danielle: A psychological formulation in the therapy world is what you think is the core underlying issue in someone's psyche that's getting in our way, or tripping them up. Similar to heart failure or in internal medicine, if someone comes in with chest pain you don't think about treating the chest pain, you think what is causing this? What is underneath? That guides your treatment. In the therapy world it’s the same with communication, you don't just look at what the patient's saying or doing, you think, "What is the formulation, what is the route behind this that's causing this?" That guides how you treat it.

Alex: What's the formulation for Trump?

Danielle: How long do we have today, Alex?

Eric: There could be a lot of different reasons people say things that they do, how do you know what's the underlying reason that they're saying something? Why did Alex just bring up Trump?

Danielle: Yeah, so it's a good question and in general you don't pick one specific thing a person did, but a guiding formulation. I will say, it takes four years of psyche residency to even start feeling comfortable during formulations, and then people keep doing this in therapy and practice for years over their career. This is why your therapists tend to get better with time. It's a hard thing to do, and I'm not advocating that everybody in palliative care immediately know how to formulate, but I am advocating that they slow it down to take the step to wonder, "What is the route behind the behavior?"

Alex: What is an example?

Danielle: Let's say the behavior you're seeing- you're in a family meeting and the family is stuck, they do not want to make a decision. You're trying to get a goals of care and they just can't. There could be different reasons, there's not one thing you do for a stuck family meeting. If my psychological formulation is, "Oh my gosh, this family is so overwhelmed by the responsibility of this choice. They are petrified of doing the wrong thing, that they're going to have to live with that burden forever." Then my communication tool is going to be something that takes away that responsibility from them. I might give them my strong recommendation, I might stop presenting it as a choice and just say, this is what we should do.

If my formulation is that their psyche is really stuck on a feeling like that their loved one is just another person to the doctors, that the doctors are pushing their agenda, and that they don't see them as an individual and that they're trying to force me one way of the other. Things are going to go south if I start giving them strong recommendations. Based on my formulation that the real core issue is, "Am I seeing their father as a person?" That's the place that I might start saying, "Tell me about your dad, tell me what he would want if her was here."

I'm going to pick different tools from my tool it, just like you'd pick a different nausea med if you had a different cause of nausea, or a different chest pain med if you had a different cause for chest pain.

Alex: This is completely new to me, I'm going to make up some words and you can tell me if this is a close approximation of what you're talking about. It's trying to understand the underlying reasons that may be unspoken, behind a person’s motivation for the way they act, behave or say.

Danielle: Exactly. What we find in the therapy world is that actually you can see a huge array of symptoms, but most people have a few core underlying beliefs that are guiding most of the things that come up in their life, right? Is it that I'm unlovable, is it that I'm to blame for anything that goes wrong? Is it the world's to blame? Who knows what it is, but most people have some organizing compass that might be leading them astray, and you pick your therapeutic communication intervention to address that. Otherwise you're just shooting at the dark, just throwing different tool and communication styles at people.

Eric: How do you figure out what those underlying issues are?

Danielle: What I would hope for in the field of palliative medicine, I think that people come into palliative medicine because they're inherently good communicators. I think there's a good amount of intuition already in this field, and you see it happening. You see someone becoming naturally more paternalistic. Something is going wrong and they just do it, or you see them become a little bit more soft, or a little bit more this or that. What I think we need in this field is for this process to become explicit. The same way that everything else in medicine is explicit. Why? Why did I become like this, why did I become like that? What am I going to try with family, what do I think is going to trip up this family?

Eric: Yeah.

Danielle: We debrief our family meetings, we say, "Okay team, what worked and what didn't work?" What does that tell us? That tells us what worked or didn't work for them, but can we extrapolate that to every family? No. What worked and what didn't work, why? Why in this case? I think the more we're doing that out loud, the more we're going to learn and be able to hone something that we're all relatively good at, at baseline.

Alex: It seems like you'd have to know the individual participants in the family meeting fairly well, in order to extract- in order to deduce that underlying motivation. Are you saying that even without knowing the individual participants in the family meeting as well as you might know them as say if you had individual therapy sessions with each of them. You can still draw some ideas or conclusions or suppositions about what might be going on, that would help your approach?

Danielle: Yeah, and I have a few thoughts on that. There are different levels of formulating. Am I going to formulate the core issue that this family has struggled with for years? Maybe not, I don't know their childhood histories and whatnot. Can I formulate what is tripping them up around the end of life care for their dad or what is the psychologically the barrier in whatever medical thing that's going on? Yeah, I think what we can do that pretty quick, and I think that we all are doing it, we're just not doing explicitly.

I'll add, if you watch a master therapist out in the community, Alex, and show them about a four minute clip of one of my own therapy sessions, we used to do this in psyche residency. You'd show them a four minute clip and they'd stop and be like, "Wait, wait, wait, wait. Let me tell you what's happening for this patient." It was amazing what they could figure out from four minutes.

Alex: Wow.

Danielle: Yeah.

Eric: Maybe it would be helpful to do maybe a little practice session, you give us a case, Alex and I will try formulating? Maybe that can help me flip my head around this topic?

Danielle: All right, here's the case. You tell me what you think of this one. Let's say you're in a family meeting, and a decision needs to be made right now about the course of a patients care. The families are listening to what the doctors have to say, but they just refuse to make a decision, they keep saying, "Okay, thank you for this information we need more time. We want more time." Meeting after meeting, "We want more time," you can't get a decision. Let me be clear, there isn't a right answer to this. This is a sample case, I don't know the formulation, what might be a formulation for what's leading to this issue?

Alex: It could be, a fear of making the wrong decision and that strong fear leads to no decision.

Eric: It could be that they're waiting for a family member to come in from another town?

Danielle: Okay, so they might be petrified of making the wrong decision, they might feel like, if you went further into the family member thing. What is? ...

Eric: They don't want to make it alone, this decision. There's an important family member who makes most of the decisions, or there's a lot of different dynamics in the family where there's a lot of arguing over a lot of past wrong decisions?

Danielle: Maybe they're scared of being blamed, yeah, that could be something.

Alex: It could be that they're the type of family that looks to the doctors to make a decision. That they aren't in the habit of making decisions and that maybe it's, "What would you do, Doc?" You need to make a suggestion as a doctor, would a recommendation help in this sort of case?

Danielle: Now you're getting into what you communication tool would be based on your formulation, but yes. It could be those things, what else could it be?

Eric: Could be that the family is scared because their loved on is dying and if they don't make a decision it may make them feel like they're not dying or they don't have to deal with that issue.

Danielle: Mm-hmm (affirmative), it could be avoidance of a really huge truth they don't want to acknowledge.

Eric: So then what do we do?

Danielle: Let me pause you there. What do we do? You took it right out of my head. Let's take that one, let's say that you think the reason they're not making a decision is because that means they have to truly acknowledge that this person is dying. They are petrified to do that. What might you say to that family?

Eric: Maybe go back into my tool box, acknowledge the emotion that this is really hard to be in this situation- to have their loved one this sick in the ICU.

Danielle: Yeah.

Alex: Yeah, draw out from them what they're feeling at this time.

Danielle: Mm-hmm (affirmative).

Alex: What are you seeing, what are you worried about? Maybe getting the other members of the team to use the word dying if they're using it amongst themselves. A lot of times the docs, "I think they're dying," but then they won't say that to the family.

Danielle: Yeah, you guys right now, is you're picking your tools. You have a compass, you're thinking to myself, "I have a guess at what the psychological hold up is" and in my mind I'm thinking, "I want this family to feel the message, what's hard here is not the decision. What's hard here is that this person is dying. That we all sit here and own the fact that this person is dying and we're not going to move forward until we do that."

Alex: Yep.

Danielle: If I had backtracked guys, and I had picked on of those other formulations that you had brought up, this strategy might not make sense. You with me?

Eric: Can you give an example?

Danielle: Let's say that this family's issue is that they are distrusting of health care, and they really don't think that you care about their father. They think that you want to get them out, they think that you're just trying to push an agenda, have it be done, you keep coming in for this decision and they're like, "Whoa, whoa, whoa hold up, this is our father, stop pushing we're not ready." If you go in there doing things that just want to underscore that you really think that this guy is dying. Let me make sure in my communication that this family gets that, "This guy is dying, let's sit with him dying."

Eric: I've never been in a situation like that.

Alex: Completely foreign, where do you come up with these things?

Danielle: That is not going to go well. We see this happen, we go as palliative care to these meetings and we see the crash coming and you're like, "No, no don't say it." Then we adjust and we're doing so much of this implicitly. "Let me jump in and ask you about blah, blah, blah. Let me jump in here." But there's so much less potential to grow and there's so much less potential to teach if we don't then later think back and say, "Why? Why did I do this? Why did this work or not work?”

Eric: It also sounds like your initial formulation may be wrong, and you'll know it's wrong and then you may have to pick a completely different formulation. For example if I thought, "They're just not acknowledging death," and they respond as they would if they were just mistrustful of the healthcare system. I would have to change my formulation pretty fast.

Danielle: Yes and you'll know it doesn't work, if I'm thinking, "Oh they're not acknowledging death," and I sit, I take a big breath and I say, "You know, they're dying." They look back at me and they're like, "Yup, they're dying." Then there's a pause, that might be a clue, okay that didn't work. My communication wasn't therapeutic. The same way that I give [pain medication], and the patient says, "Nope, my leg still hurts."

I'm like, "Oh, okay that didn't work, what did I have wrong here?", and you adjust. What we don't want is people either seeing something working and thinking, "Okay that's going to work, that's how I do family meetings, that's how I break bad news, that's how I do it." It's going to be different for everybody. We also don't want people just shooting in the dark, "Oh this didn't work, let me ask, hopes and fears, oh that didn't work. Let me ask this." There's so much less potential for growth if we just kind of keep shooting in the dark from some pretty good tools. We have a good tool kit.

Eric: Right.

Alex: Are there things that I can do as a palliative care provider to practice this skill or learn more about it?

Danielle: Yeah, let's start with practice. I started to say this, I think some things, like I was saying, make your thought process explicit. Don't just recommend something communication-wise to another team but tell them why. When you're going into a meeting with a team and you've done some debrief and given them your tips, maybe ask them something like, "You know this family best, what do you think is going to trip them up? What's going to be their core struggle in this room?" By asking these questions, not only are we setting ourselves up for a much better family meeting than our basic pre-hash does, but we're teaching them to think like this, we're teaching ourselves to think like this.

We'd start there, some people get really bothered by the thought of changing their communication, like I'm telling them to be a robot. "For this type of person say this, and that type of person say that." That's not what we're advocating at all. What I would add is knowing yourself really well helps. Know the types of formulations, the types of family meetings, the types of hold ups that your natural style and the tools that you like to go for naturally work well with.

Go in on autopilot with those ones and know the ones that you get tripped up on, so that you can think through, "Okay I think it's this formulation, before I go in, let me think about how I might tweak my natural style. Do I need to be more paternalistic? A little less? A little more straight shooter? A little less? Softer, harder?" Find authentic ways to tweak yourself, not change yourself, but tweak yourself so that you're therapeutic to the person.

Alex: I wish we could also, like when you said before for when you were in training, you had some master therapist look at your therapy sessions for four minutes and give you feedback that was remarkably elucidating. I wish we had some sort of coach that can come with us. I think back to my training, with Susan Block there, learned so much from having those encounters. I wish we could videotape our family meetings and bring them back to Dani so that she could tell us what was going on.

Danielle: That would be really fun, and a great way to think through it, yeah. A majority of my psychiatry therapy learning happened sitting in a room, watching someone way smarter than me watch clips of me fumble.

Eric: Maybe a suggested reading so we could learn a bit more about this, we can put some articles up on our Geripal website with this podcast?

Danielle: Yeah, we'll look for some. It's funny in therapy, I don't know how much you guys experience this, people are very wedded to their school of therapy. "I'm an analyst. I'm a CBT person. I'm a family therapy person." They all teach formulation, but they do it with their own little words and their own little processes, but the content of it is so similar. Maybe we could get a few examples from different schools, whatever speaks to you, it's different ways up the same mountain.

Eric: You have one more comment?

Danielle: I have one more comment, yeah. I was just thinking about sometimes when you're sitting in a therapy case, you can go hour after hour with somebody and then you know you hit something good because one thing you say, lands differently. The whole energy of the room changes. I know that you guys have been in a lot of family meetings, you've had that feeling right where the meeting is going one way or the other and one comment from one person just shifts the energy. You know it, you're like, "We hit it."

Eric: Right and I think ...

Danielle: Now we know where we're going.

Alex: In our debrief about it, we do often go to what was the information content there? Rather than, what is the underlying psychological construct? That dynamic that was going on in the family meeting, what was the formulation behind that change? Not just the information.

Danielle: Exactly because if we just went with the information that would just mean that that one comment is going to be your money spot for every single meeting, right. It just doesn't work like that.

Alex: Although it's called formulations it's not a formula.

Danielle: Bumper sticker!

Eric: Thank you Dani.

Alex: Thank you so much Dani. Sometimes you're in that family meeting and you feel like you're in free fall.

Danielle: Sometimes you do.

Eric: I was wondering how you were going to bring up the song, Alex.

Alex: This is my favorite verse.

Alex sings “Free Falling” by Tom Petty.


Transcript was edited by Sean Lang-Brown
Read more »

Tuesday, December 6, 2016

Antipsychotics Worsen Delirium and Make You Die (Slightly) Faster…



Antipsychotics are often used to treat delirium, although the evidence behind their efficacy is pretty minimal.   That evidence is even worse when it comes to patients with advanced illness or those nearing the end of their lives.    This week’s JAMA IM gives us the first placebo-controlled trial of two antipsychotics, risperidone and haloperidol, in relieving symptoms of delirium associated with distress among patients receiving palliative care.   The results do not look good for antipsychotics.

The Study

This was a randomized controlled, double-blind clinical trial done in eleven Australian inpatient hospice or hospital palliative care services.  Patients all had life-limiting illness, delirium, and symptoms of delirium that are associated with distress (inappropriate behavior, inappropriate communication, and illusions or hallucinations).

The participants received either placebo or pretty conservative age-adjusted doses of oral risperidone or haloperidol every 12 hours for 72 hours, titrated based on symptoms of delirium.   All of the patients, no matter what they were randomized to, receive individualized treatment of delirium precipitants and other measures (hydration, vision and hearing aids, presence of family, and reorientation).   Subcutaneous midazolam was available to all groups if required for severe distress or safety.

The Results:

In the primary intention-to-treat analysis, those who received risperidone or haloperidol had significantly worse delirium symptom scores and delirium severity scores than those among participants in the placebo arm.

Not only did they have worse delirium scores and severity scores, the antipsychotic group had more extrapyramidal effects and worse overall survival (although for risperdone this didn’t reach significance).

Lastly, use of rescue midazolam was significantly lower in the placebo group versus those who took an antipsychotic.

The take home

I’ll just finish up with a quote from the accompanying editorial:
“Using antipsychotic drugs to treat delirium in terminally ill patients, not only are they not reducing distress but they are in fact worsening patients’ symptoms.”
While that sums up my thoughts nicely, I do have to wonder though about the use of a benzodiazepine as a rescue medication, and how that influences the results of the study.   The overall consensus is that we should avoid benzodiazepines in delirium except for very limited indications (i.e. alcohol withdrawal, seizures).   Even when using it for "terminal" delirium, the use of benzodiazepines is questionable as it really is a diagnosis done in hindsight (you only really know its terminal delirium when someone died with delirium).  Use of a benzodiazepine probably made the situation even worse for the group that used more of it (the antipsychotic group), but it probably doesn’t change the fact that antipsychotics made people initially do worse so they needed more of the rescue.

Kaplan-Meier Survival Curve for all 3 groups 
The other very big caution is not to generalize these results outside of those included in this study.   These folks were sick.  I mean very sick.  Median survival in the placebo group was 26 days compared to 16 and 17 days in the haloperidol and risperidone groups.   The Kaplan-Meier Survival curve for all groups, including placebo, looks like a line art drawing of the White Cliffs of Dover.  

Is there a role of antipsychotics for healthier individuals with delirium in which we are not making things worse by giving a benzodiazepine as a rescue?  Maybe.  Maybe not.   Not sure I can say so with the results of this trial.

What do you think?

by: Eric Widera (@ewidera)



Read more »

Monday, December 5, 2016

The Conversation - An Interview with Angelo Volandes on Video to Improve Advance Care Planning



This week on the GeriPal podcast, we talk with Angelo Volandes (click here to listen) (see transcript below).  Angelo Volandes is famous for his use of video to improve advance care planning conversations with patients and their families.  In this podcast we ask Angelo "why video?" We hear the story of how he got the idea for video in the first place.  And we push him about the potential for bias in these videos.

If you want to read more about Angelo's work, please check out the following:
by: Eric Widera (@ewidera)

---

GeriPal Podcasts can be found on:



--------------------------------

Transcript of the Podcast

Eric:      Welcome to the GeriPal Podcast. This is Eric Widera.

Alex:      This is Alex Smith.

Eric:      Alex, we have another special guest with us today.

Alex:      We do! We have another special guest. We have Angelo Volandes who's coming here from Boston, from MGH (Massachusetts General Hospital). Angelo is a well-known researcher around the country. We got to know each other a little bit during your Bioethics fellowship and my Palliative Medicine fellowship, I guess. That seems like ancient history now. I guess, are we old enough to be able to say that?

Angelo:      Ancient history. We were taking Clinical Effectiveness classes together and enjoying statistics.

Alex:      That's right. Welcome. Thank you so much for coming and joining us today.

Angelo:      Thank you for having me. It's a real pleasure to be here.

Alex:      We usually start off with a song here.

Eric:      I think Angelo has picked one, is that right?

Alex:      Angelo has picked a song. A fine choice. Johnny Cash, Folsom Prison Blues.

Alex plays "Folsom Prison Blues" by Johny Cash.

All right. Well, welcome to San Francisco from the other side of the country. We are so happy to have you with us. We wanted to first get a sense from you about what you're doing. What you're known mostly for is video advanced care planning. I think the question that's on a lot of people's mind is why would you do this? How did you come to this idea? Why video when all of what's been done so far has been pen and paper and that stuff?

Angelo:      Yeah, that's a great question. Don't you want to play with a video camera instead of a stethoscope sometimes? I'm walking around the hospital having a film cam.

Eric:      That's why we had a bunch of microphones in my office right now.

Angelo:      This looks like my studio, my editing studio, here.

Alex:      We're moving in your direction. So far, we moved from web blogging to audio.

Eric:      Yes, and I guess the next step has to be video.

Alex:      The next step in our evolution would be video, but I don't think anybody wants to see us.

Eric:      No.

Alex:      They may want to see you, though, Angelo.

Angelo:      I even dressed up. I thought this was going to be video. I had my tie, my jacket, looking for a little audio and visual. No, but the idea of the video really came through residency. I was admitting patients, and a lot of times I was asking myself, "What are we doing to some of these patients?" Especially patients who had advanced illnesses and hadn't had conversations. One particular patient that I started having my conversations, she had an advanced illness. It was clear to me that when I was talking about goals of care, she didn't really have an understanding, and so I asked her, "Would you mind taking a tour with me around the hospital?" Of course, she agreed. We didn't walk. I put her in a wheelchair and I took her around the hospital to the ICU. She got to see a vent, a patient on vent, and as fate would have it, she actually witnessed a code.

     I brought her immediately out of the ICU, but she got to see what CPR looked like. When we went back to her room, we had a very different conversation. It was clear that the visual had helped her in a way that words clearly didn't. Obviously, we can't take people on tours, and that's really when I got the idea of using videos. Now I should also ... A little confession. During med school, I studied film. I took some time off to study film, so it was natural to meld the two. From there, I said to myself, "Why not take everybody on tours? Why not bring people to where it's at so that they get a better understanding as opposed to television where everybody survives CPR and everybody looks like George Clooney on a vent?"

Alex:      Right.

Eric:      Just to summarize what I know about the studies that you've published is that it looks like adding video to advance care planning significantly influences how people make decisions. Generally, people are wanting less aggressive end-of-life care than if they didn't watch the videos. Is that a okay summary?

Angelo:      Yeah, I think the first word that you said is, "Adding video." A lot of times, people think this is to replace the doctor-patient relationship, and I'm like, "No, it's not to replace. It's to reinforce it." This is just an add-on. An enhancement. At the end of the day, what we want are conversations, not videos, but it just happens that videos catalyze the process. It gets people going. Our brains have been rewired where we want visual material. What we find is that people are more informed with a video, and when they're more informed and they have an advanced illness, they tend to make decisions more towards comfort care, which is what we know from all these surveys, that people don't want to suffer. They don't want to prolong the dying experience. They're more informed, and when they're more informed, they tend to make decisions towards more comfort-oriented care.

Alex:      Now I have read your book, which is a fantastic book. We should plug your book. The name again is ...

Angelo:      "The Conversation."

Alex:      Thank you.

Angelo:      Amazon. Audio. Whatever you wish. iTunes, too.

Alex:      Your website which is?

Angelo:      The website is ACPDecisions.org. There's actually some free videos on that in both English, Spanish, and a bunch of patient checklists in like 20 different languages.

Eric:      We'll have links to all of those on the GeriPal website.

Alex:      Yes. Now I remember you had some examples of videos in your book, and I've seen some examples online and read many of your papers. Are there particular conditions for which video may be better suited or less well suited?

Angelo:      Yeah. The things that we see day in and day out that people don't see or that Hollywood doesn't see the way we see, Dementia. That's clearly a big one, the advanced stages. We talk to our patients and they think of Ronald Reagan, whereas we know in the advanced stages it's someone who can't walk, can't talk, and feed themselves. Those situations are really important to capture. Some that aren't or that are just a supplement are some of the Pal-Care conversation things that we focus on like values.

     To start that, videos are good, they help the doc or the nurse have a checklist of things to remind themselves to ask, but that could also be trained. You could train people to do that. When it comes to advanced illnesses, interventions is a key one. I was just over at one of the hospitals here in the Bay Area and we were filming Trach and Pegs. I think if I was a daughter in the ICU trying to figure that out for mom, that could be a tough one. To actually see and understand what life is like in an LTACH facility, I think those are important to be captured on video.

Eric:      How do you think about this question of bias, and when you are videoing something, how to make it both realistic ... I am guessing every video, you have a frame of reference, a potential bias, or an idea of what a good decision is. Your thoughts on that.

Angelo:      Two points. The bias and then the good decisions, or the right decision. Bias is hard. If you watch Fox News, Trump won, not only the electoral college but also the popular vote, whereas if you watch MSNBC we know the reality is he lost by 2 million votes. The visual medium is an aesthetic medium. You can change, edit, zoom in on a patient who is intubated and have that saliva drool and the breathing. Or you can do something that is more impartial. We spend a lot of time and we have come up with a series of criteria that people need to follow, certain angles, having a narrator, not using testimonials, even though we are narrative creatures, I could convince you if I wanted with the right patient telling me a story of how they survived CPR, even though statistics are that if you have an advanced illness, it is in the single digit percentages, so we are very careful about that. I make no qualms about it, the truth is that this is a biased medium. The best thing we can do is have lots of people review it. I always say that the end user has to view it and that is people who have had this illness or the families.

     Your other question, which I am forgetting, was "what is the right decision?" The right decision is what Alex tells me is the right decision. What is the right decision, it is what my patient wants when they are fully informed. What I hate is when I see my residents or my med students, the check box, did I ask the question. I am like, was it an informed discussion? The right question is when people understand their options. I happen to feel that video adds a lot of information, but at the end of the day the right option is what my patient wants based on their assessment of the risks and benefits. Also, as a doctor, I think that we have to make our recommendation and the most common question is what would you want if this was your mom? I invite those questions.

Eric:      It must be an absolutely fascinating reviewing process because I remember we did journal club. We have done, I think 10 of your articles on journal club, but one of them was a video of someone with advanced dementia and the big discussion was did she look enough like she had advanced dementia or did she look too much like she had advanced dementia?

Angelo:      It is a wonderful question. That particular video, I get so criticized for. Because let's face it, she looked really good.

Eric:      She does.

Angelo:      I mean she had rouge, she had pearls. I put the make up on myself. She was being cared for and fed by her three loving daughters. That is not usual care, folks. Most people ... I actually, there are 21 Alzheimer centers around the country, probably more now, but when I made that particular video I asked them to send me what they had about advanced dementia. Only one place actually sent me something. It was a patient who was in her hospital bed, filled with feces, in a diaper, and half naked. I would argue that is probably more reflective of the reality. What our group said was lets show what the nicest version is and let's just see if there would be an effect with the nicest version. With that first study, when we saw that there was a tremendous effect in decision making, we said, could you imagine what it is really like if people actually saw it.

     I actually get criticized for this by a lot of docs. When I give a talk and they watch our CPR video, they are like, where is the blood, where is the gore. I tell people that this is not about gratuitous violence, it is more like a drug study. Start with the maximum dose, see if there is an effect. Here we are, showing the nicest possible situation, never show blood, and see what people think about or what do they think about the video? Is it palpable? How does it influence their decision, their knowledge, their anxiety, their depression? I say that if this is the best of both worlds and people still make decisions towards comfort care, could you imagine what the reality is like if they saw it for real?

Alex:      I have heard the criticism of some of these videos, not just yours, but others and this concern about bias. There is a little bit of unfairness to that, I think. Our language is often bias. I have heard docs say things to patients like, if you have CPR, I am going to have to crack your ribs, I may have to cut open your chest and massage your heart, which is ridiculous because that hardly ever happens. I have heard them say things like do not punctuate the end of your life with this senseless act of brutality. So there is certainly framing bias with the language we use, and yet the most common conversation out there is probably like, if your heart were to stop, do you want us to restart it? Or something horrific like that.

     There is, we have to recognize, our limitations to the language that we use and there is certainly propensity for bias there in many different directions. Video, what you are proposing to do is revolutionizing the way that we approach advanced care planning. Having standardized videos for whole populations. That is where it becomes critically important because as you do, we take a really thoughtful, measured approach, deciding on the videos, which we show to thousands and millions, potentially, of people.

Angelo:      Exactly. It is more of a quality issue. Look, every time that I am on service I have my med student and my residents, we play the newlywed game. We all go into perpetrate rooms and I sit down, I am a patient of advanced cancer, let's have the conversation. I usually have my med students say, ìyou don't want me to gently push on your heart, if your heart stopped beating.î Whereas my interns are like, ìI don't want to crack your ribs or anything.î And then my senior resident is like, ìwell if you have the V FIBÖî and I'm like, ìV FIB, what are you talking about?î

     This idea of bias, I think that our language is far more biased, just like you said. I would actually have more comfort in a standardized video that has been vended by people that has been studies, over decades worth of research, so that even if you are a good doc having this conversation, or if you are a bad doc, at least the patient doesn't suffer and the family gets some information, in a standardized fashion.

     You're absolutely right. This is where Pal Care systems, information systems, thinking comes into play because now we are talking about can you take this to scale. That is where it gets interesting because you can train one doctor, one nurse, one provider at a time or you can try scaling video, which is cheap. It is cheap. Totally cheap. But you can start influencing on a larger scale, peoples information and how docs start behaving.

     One of the best things that I have noticed as a provider in my own hospital is now physicians, residents, med students, start emulating what they hear in the videos and seeing that in their records. That is behavioral change. Then, having patients and families start using the language and start asking their providers, sort of flipping the dynamic and the power structure.

Eric:      You just published a study showing that you scale this intervention in Hawaii, is that right?

Angelo:      Hawaii. It has been thirty two trips. Thirty two trips in two years. It is a great ...

Eric:      The place to scale your intervention. I have to do research in Hawaii too in the future. Don't I? At my age.

Alex:      Yes.

Eric:      Podcast on the beach.

Angelo:      Hawaii was amazing. It just happened to be one of those opportunities that just came around and you had nothing to do with it. The Blue Cross of Hawaii, Hawaii Medical Service Association, had read one of our ... We were covered in a magazine, I think, and they called me up three years ago, and they said, do you mind coming and giving a talk. I was like, hell yeah, I had never been to Hawaii. And I gave the talk but it was unusually because it was in the executive suite of a corporate building. It wasn't a bunch of docs. I was like, this is weird. I gave my usual talk and one of the C-suite folks said, would you be willing to make the conversation the standard of care here in the state of Hawaii, by using videos. I am like, Hawaii is pretty nice, sure.

     What we did is we tried to scale it so that we not only hit hospitals but we went to clinics, outpatient practices, specialty clinics. Then, we started going to churches, synagogues, elderly housing. We started going on television, radios. Over the last, let's see the paper that you read was the first 20, 18 months, where we looked at 42 thousand covered lives, and what we saw was an increase in documentation, hospital and patient by 40%. Increase by hospice discharges by, I think it was 22%. Also, and I don't think we included this particular one in that paper, a decrease in hospital deaths by 22% for late stage patients. That is incredible!

     It wasn't just, let's have the conversation when you are about to get tubed in the ICU. It was also, let's bring it out to churches, out into the community, let's get the community involved. There are so many different videos. Our videos is my wife, who is African American narrator. We didn't think that would work in Hawaii necessarily so we used the chair of medicine of Hawaii, who looks a lot more Hawaiian. So we re-film a lot of the videos. We also did it in different languages, which is key, because you want to meet the end user where they are at. These weren't just Google translate, they were adopted and adapted.

     In Hawaii, it was Chinese, Cantonese, Mandarin, Vietnamese, Korean, Japanese. Marshallese, some of the minority languages as well. It has been a fascinating understanding because even though it is about Pal Care, it is also about QI, a lot of this was just quality improvement stuff. It has been a fascinating experience. We are still not complete in terms of the entire state, but right now anybody in the state, 1.4 million residents, have access to all of our videos and it is now the standard the care for most health care settings in Hawaii.

Eric:      I presented one of your articles at the American Geriatrics Society Meeting last year. I think that the biggest question I got was, ìhow do I get these videos?î

Angelo:      We created a non-profit foundation that just does this. I am more of, my responsibilities at MGH are all the research. What we did is for the masses, for everybody, we have free videos that are readily available and they are free videos that anybody, anywhere can use, but you can get started with the process. It is our five most common videos which is, ìhow do you have the conversation? What is palliative care?î because we think that there is too much misinformation about that, about pulse forms, also about, ìhow do I talk to my doctor?î Those are free and available, and they are also in different languages. People can just go to the website and use those as they wish.

     For places that have an infrastructure, where they have taken this on, then we ask them to license the videos through our non-profit, that is how we keep going to make more and more videos. For, I would say 99% of places, all that they need to do is use the free videos and start the process. We have them out there. They have been available for the last few years and in different languages.

Alex:      That is great. What is ahead, what is the next step, what is the future, where are we going here?

Angelo:      One of the hardest things for me is talking to an audience and getting NICU nurses, coming up to me saying why aren't you doing this in the neonatal ICU. I was like, NICU, I haven't been there since third year medical school, what would I go there for? That is where it was fascinating. Pediatrics, the variability of how this is occurring in pediatrics populations, whether it is for the extremely premature infants or pediatrician, that is where I think that this really needs to occur because there just isn't enough standardization. We are focusing now on pediatric populations, as well as care givers. Not creating videos just for patients, but for the sons and daughters who are making these decisions.

     For example, we were just working on a video to help say a daughter of a mom who has advanced dementia, or advanced heart failure, and they now have shortness of breath. How do I know when to take my mom to the doctor or to the emergency room versus trying to do some simple things at home that might be able to alleviate some of the symptoms?

     In terms of the research, what we have done, over the last decade it has been more of randomization at the individual patient level, whereas now it is at the facility level. Now we are doing large pragmatic trials. Our biggest one is six hundred nursing homes, half of them get usual care, the other half get our suite of nursing home videos, and looking at about an end of about 100,000, using MDS data base, and CMS data, looking at what happens to rehospitlizations, interventions, and stuff like that. Which is very exciting because ...

Alex:      That is incredible.

Angelo:      ... I know that that's the sort of stuff that gets you going as well.

Alex:      This is amazing.

Eric:      I am just trying to figure out how this works as far as, workflow in the hospital is for a hospital...

Angelo:      It is all done differently and I think that you have to be respectful of the local medical milieu before you say this is how you do it. Some places have the nurses during the intake on the floor -they do it. Other places have the docs show it. Other places say this is an interdisciplinary thing, it is not the pervue of just the docs, we are going to have our social workers do it. It all depends. Most of the places it is an iPad or on a tablet. Not on a TV which is twelve feet away but you know, it is very powerful when I use it with my patients. I have it on an iPad, it is a few inches from the patients face, often I will have a family member scooch in with mom on the hospital bed, and it is a powerful experience. I just sit back and observe them, I don't watch the video, I look at them. So much of the information I get is just looking, not at what they are saying, but at their body language. That is just powerful to watch.

Alex:      The non-verbal communication.

Eric:      Did you see the JAMA IM article that came out yesterday on ...

Alex:      Laura Hansen.

Eric:      Laura Hansen's randomized controlled trial of ...

Alex:      Video advanced care planning for nursing home residents with advanced dementia, actually for their surrogates.

Angelo:      Absolutely. It is for the surrogates. Both Laura and Susan Mitchell, the senior author, are my colleagues. Susan is actually my co-PI on two of our grants and Laura is a co-investigator on one of those grants. What I really enjoy is to see more people doing this because I think that it is important because of that issue of bias. To have other people make all different types of videos, I think different frame works, different perspectives, artistic choices, colors, literally colors of graphics, the type of people that you pick, or who is the narrator.

     I enjoy more and more people studying the use of video. The video is here to stay folks. We are on audio but it is going to go to video very soon. It is just our brains are rewired just like that. I invite other people to try to do this and I encourage people to just try different things. Even though we have a couple hundred videos now, in 20 different languages, I tell people to do the same things that we are doing because you will have a different take. And we have to see because it is still a very nascent field.

Alex:      Rebecca Sudore in our group has her own video take on things that prepare for your care.

Angelo:      I think that Rebecca is a pioneer in this. She was the first really, to use videos in the advanced care planning context. What I love about Prepare for Your Care is that it is values neutral but it walks you through at a wonderful way, at a means that people with a low health literacy can understand. Vulnerable populations. It is just wonderful. In fact most of my patients know about her site. In fact, I would say most of our videos include a link to Prepare for Your Care, because I think that is the way to scale something like this.

Alex:      That is terrific. How should we wrap this up Eric?

Eric:      Maybe a little bit more Johnny Cash, just to finish us up.

Alex plays "Folsom Prison Blues" by Johny Cash.

Transcript was edited by Sean Lang-Brown .


Read more »

Wednesday, November 23, 2016

The Role of Cranberries in Preventing Urinary Tract Infections



Just in time for Thanksgiving, we are having a GeriPal podcast episode dedicated to the humble cranberry (click here to listen).

We discuss the use of cranberries to preventing urinary tract infections with Dr. Manisha Juthani-Mehta.  In addition to hearing about something called proanthocyanidin, we discuss her recent publication in JAMA on whether cranberry capsules decrease the presence of bacteriuria plus pyuria in older women living in nursing homes (spoiler alert - they don't).

If you want to read more about the paper, as well as a Cochrane review summarizing the evidence for cranberries to prevent urinary tract infections, please check out the following:

by: Eric Widera (@ewidera)

---

GeriPal Podcasts can be found on:


Transcript of the Podcast:

Eric: Welcome to the GeriPal Podcast. This is Eric Widera.

Alex: This is Alex Smith.

Eric: And Alex, we have a special guest with us today.

Alex: Who do we have today, Eric?

Eric: So we have Dr. Manisha Juthani-Mehta, who's with us. And can you, Manisha, just describe where you are and what you do?

Manisha: Absolutely! So I'm a faculty member at Yale School of Medicine. I'm an infectious diseases specialist. I've been doing research on infections in older adults for about the last 14 years and I'm also the ID (Infectious Diseases) Fellowship Program Director here.

Eric: And you have written a lot on geriatrics and palliative care infectious disease issues, especially writing about UTIs in older women. I remember a 2014 JAMA article. That is one of my favorite articles when it comes to UTIs and how to think about them in older adults. Is that right?

Manisha: Well thank you! I've never thought of myself as haven written so much, but it's nice to have a fan and somebody who actually knows your work.

Eric: We just had journal club on one of your articles, “The Effect of Cranberry Capsules on Bacteria Plus Pyuria Among Older Women in Nursing Homes”, just published in JAMA late last month.

Alex: It's topical! It's Thanksgiving!

Eric: It is Thanksgiving time.

Manisha: Exactly, that's why I think it's so timely, because people obviously are thinking about all the cranberry products that they love at Thanksgiving time.

Alex: It also stirred a little bit of a controversy online, but maybe before we get to that, we can just talk a little bit about why you decided to study this.

Manisha: Absolutely. So as you know, UTIs are certainly the most common infection diagnosed in older women in nursing homes. One of the main challenges is that it's so difficult to differentiate asymptomatic bacteria from a symptomatic UTI population because of the challenges with deciding what's a real symptom and what really is a clinically important UTI that deserves antibiotic treatment. And so I spent a number of years trying to figure out better ways to prevent, to diagnose, to manage UTIs and I started a couple of different pilot studies. The first one was looking at the feasibility of cranberry capsules in this population. And the reason we got there in the first place is because of a 1994 JAMA paper that looked at cranberry juice cocktail for prevention of UTI in older nursing home women.

That particular study, which was conducted in assisted living facilities and in nursing home residents showed that 10 ounces of cranberry juice cocktail was effective at reducing bacteria and pyuria in that population. But the reality is that it's so hard for so many women to actually drink 10 ounces of cranberry juice cocktail. Some of them complain about the taste, some of them don't like the glucose load, some of them are just are trying to avoid hydration, period, because of incontinence. And so this is why the idea of capsules was an appealing alternative.

Alex: Right, so you made these capsules. And how similar or different are the capsules from the kind of like folklore medicinal remedy out there of cranberry juice?

Manisha: So this is some of the challenge in the capsule literature and the capsule space in general. Capsules in the United States are not really regulated by the FDA. The FDA has some general guidance out there but there are manufactures that make products on the market that have all different combinations of what is in the capsule. Is it the actual full cranberry itself? Is it a component of the cranberry? And prior literature showed that 10 ounces of cranberry cocktail juice had 36 milligrams of proanthocyanidin, which is a type of tannin, or PAC for short.

So proanthocyanidin. P-A-C. So PAC was what is thought to be the important ingredient in cranberry juice, and it is thought to inhibit binding of e. coli to your epithelial cells or to bladder wall cells. So I used a product that specifically had 36 milligrams of PAC in one capsule. And the reason I did that was to try to mimic the juice trial that actually showed to be a benefit. Then based on a dosing study that I had done before this particular trial, it looked like we had a dose-dependent effect, where we looked at zero, one, two and three capsules, cranberry capsules with 36 milligrams of PAC in each one. And it looked like two capsules was the best dose to test. It seemed that we had more inhibition going on. It also seemed like that was the best dose that patients actually could take, and that's why we ended up testing the equivalent of 20 ounces of cranberry juice cocktail, so double what the 1994 study showed, or 72 milligrams of PAC.

Alex: This point you make about what, proanthocyanidin ... Say that five times fast. Proanthocyanidin. Proanthocyanidin. PAC, right? ... is that it inhibits binding of e. coli, which is the bacteria, most commonly, that causes UTIs. It inhibits the binding of that bacteria to the bladder wall. This is an important point that you bring up and I wonder whether that would affect bacterial replication within the bladder. In other words, does the bacteria need to bind to the bladder wall in order to proliferate and cause bacteria? Or is there something about the binding of the bacteria to the bladder wall that causes symptoms?

Manisha: Right, so I mean I think that's one of the challenges and nuances of this type of study. So to your point, this is supposed to inhibit binding, which is what is thought to then lead to an inflammatory response, more white blood cells, potentially then symptoms or what would potentially be an invasive cystitis or bladder infection. And so that's why binding has always been thought to be important in this whole pathway of UTI. The challenge in the study is what we did was look for whether the bacteria were present in the urine. So whether they were actually binding or not is difficult to tell, but certainly if they are present they could bind. And so that has always been a surrogate in all UTI research, is the presence or absence of these bacteria in the urine.

Eric: So just to restate what you did. This was a double blind, randomized, placebo-controlled study. So one group got placebo, the other group got these two oral cranberry capsules. They were nursing home patients. They were women. And they were English-speaking and all had to be 65 years and older. A whole bunch of nursing homes -21 different nursing homes near New Haven. What did you guys find?

Manisha: We screened over 5,000 patients in these 21 nursing homes. We enrolled 185 women and one of the biggest reasons that women were not able to be enrolled was because they just could not provide a clean-catch urine specimen. We were not allowed to catheterize patients to obtain urine specimens, because when you catheterize the patient, you could introduce an infection, and because these specimens were all collected when patients were asymptomatic, we couldn't justify that.

So we collected clean-catch specimens at baseline, and every two months, so a total of six other specimens, for the course of a year. And unfortunately, what we found was that the rate of bacteria plus pyuria in both groups ... in the control group and in the active cranberry capsule group ... was basically the same. So we controlled for a number of variables, but despite that, we were not able to show that over the course of a year there was any benefit.

Eric: You know, the adjusted results seemed like that one of the primary findings ... In a randomized control study, why the major focus on the adjusted results rather than just un-adjusted?

Manisha: It's interesting you ask that, because the un-adjusted results, which are also there in the supplement,that was actually what we wanted to present, because I think it's just intuitive for people to understand the un-adjusted results, which were also not significant. But in our statistical analysis plan, which was in the grant, in the protocol, all from the beginning, it was the adjusted results that were our primary outcome. And the reason that that's also important is that we took into account the level of incontinence, the amount of missing data that we had, so there were participants who could've provided one or two specimens, and they may have missed a specimen, then they may have provided another one, or any combination of that over the course of the entire study.

We also had people that dropped out because either they became hospice or died, or for other reasons decided they didn't want to take the capsules anymore. So to be able to account for all of that missing data, the adjusted analyses were important. What the adjusted analyses showed though was that it even brought the data more to the null.

Alex: You know, I want to ask also about the secondary outcomes that you looked at and specifically things like hospitalizations, gram negative bacteria, antibiotics for a suspected UTI, total anti- microbials. And if you just look at the numbers, yes, there are no statistical differences. But if you look at the percentages among treatment group for hospitalizations ... 40% rate per hundred person years versus the control group, 60%. Antibiotics for suspected UTI. 8% in the treatment group versus 11% in the control group.

Eric: You know, when we were talking about this in journal club it kind of struck us that there may be something here and that something may have more to do with symptomatic concerns that raise a level of hospitalization or antibiotic treatment, but we're just not ... We may not have the power to detect it or something along those lines. What are your thoughts about that?

Manisha: One of the reasons that we couldn't adjust for the secondary outcomes the same way that we did for the primary outcomes was because there was just a lot of variability in terms of the numbers of each of the different outcomes and each of those different categories that we looked at. And so there were a lot of confounders that actually ... looking at adjusted results would've been very deceptive. So what we presented were the raw numbers essentially, and the adjusted results.

And you're absolutely right. It looks like, well, could there have been something there? Is there something that we're not seeing? That's certainly possible, that if we had had a larger sample size, could that be the case? If you look at symptomatic UTIs alone, using a very strict definition, ten versus twelve symptomatic UTIs, we obviously didn't find any difference there. And that included people who were hospitalized or who were just treated in the nursing home alone. But I think that the secondary outcomes, although the numbers were in that direction, I just think that the level of co-morbid disease at baseline for these groups was different. And we couldn't do statistical comparisons there, just because there's too many different co-morbid conditions on which to compare.

Alex: I'm kind of bummed about these results. I was hoping that cranberries, cranberry juice, cranberry capsules, proantho blah blah blah, PAC, whatever it is, would be effective because this is ... It's practically harmless. It's easy to take. It's pretty cheap. It doesn't spread antimicrobial resistance. How did you feel when you unblinded these results?

Manisha: I had several emotions, which I will tell you about. So the first is ... Obviously I've spent probably about eight years of my life studying this, so certainly I was hoping for a positive result. I think that as you said, it's a relatively harmless intervention and I was hopeful that for an infection that is so hard to diagnose and leads to over-prescription of antibiotics, that this would be a simple intervention that maybe could make a difference in these patients' lives. So certainly I was disappointed.

Having said that, I think that the cranberry capsule industry you've talked about is relatively cheap. Capsules in the free marketplace, or if you look at, let's say, a month's supply could be anywhere from something like six, seven, eight dollars, up to 200 dollars a month. And a lot of that has to with what is actually put in those capsules. Half the time I don't think consumers really know what's in them because they can market things without it having to be validated in a way that medications have to be. And so I think that consumers are a little bit victimized, I believe. And so I have had multiple patients, from people who have emailed me, who've given me anecdotal advice, and their own experiences, and there are people who feel strongly that they work for them. That whatever brand of product that they use really works for them. If they start taking it before getting a UTI or when the symptoms first start or something along those lines, that the capsules really work for them.

I think that ... My fundamental feeling is that cranberry products have been used and were used by Native Americans for thousands of years. When the pilgrims and first settlers came to the United Sates, they learned how to use the cranberry, which was one of the few fruits native to North America. They learned how to use it for a number of purposes, whether it be to prevent scurvy, whether it be to barter with Europe, and whether it be to prevent or treat urinary tract specific symptoms.

So I think that there are many women who will say that if they get symptoms of a UTI, if they start drinking cranberry juice, it will alleviate the symptoms. And so I have to believe that there's some anti-inflammatory effect or something that we have not identified in studies when we're looking at how much bacteria is in the urine. That's what most of the end points for most of the studies have been out there. If we look at that end point, most of the data does not suggest it works. But if we look at anecdotal information about what women say helps them, it seems that cranberry juice may prevent some of the burning that comes with the UTI.

Eric: So I got a question. I've never heard of Big Cranberry before but I saw a press release from the Cranberry Institute that took ... What's the right word?

Alex: Took issue? Took umbrage?

Eric: Yeah.

Manisha: Yes, I think would be fair.

Eric: I saw a press release from the Cranberry Institute that took issue with this study, and especially with the accompanying editorial, which basically said it's time to move on from cranberries for preventing urinary tract infections.

Manisha: That's correct.

Eric: Your thoughts or response to that?

Manisha: So I have to say that given that this was a negative trial, I did not anticipate so much interest in this trial. I thought that there might've been more interest if there was a positive study, but I think the concept of debunking a myth was interesting to many people in the lay press and was very disturbing to people in the cranberry industry. In terms of moving on from cranberries, I think it's fair to say that what we tested in our trial was cranberry capsules with a very high PAC content in nursing home women. And I think in my opinion, it is fair to say it's time to move on from cranberry in that population.

Eric: What do you think about the idea that this study did not test it in the right population, not those individuals with recurrent UTIs, but just women living in nursing homes who are older?

Manisha: Yeah, so I tried to do that in the dosing study that I did. What I did was, I said only if you have a history of UTI and I defined that very loosely and broadly, which was ... If you had documentation of you were treated for UTI in the last year, only then could you be enrolled in the study. And it's very interesting. People who have done research, a lot of people have found this. The minute you start studying a disease, it goes away. It's the best way for an illness to be cured is just to study it. So enrolling people with a history of UTI was virtually impossible. Now look at what we did in our study. We screened over 5,000 women and we didn't even make history of UTI a requirement. I should correct myself, not 5,000 women, but over 5,000 nursing home residents. Some of those were men, so they were excluded because they were men.

So again, what we were looking at was asymptomatic bacteria. That's really what we were looking at. That was our primary outcome. So it would've taken hundreds of nursing homes throughout the United States, for a much longer period of time probably, to be able to test that specific question.

I think that that question has been tested in younger populations, in other age groups of women, and I do think that the vast majority of literature that's out there using either juice or capsules ... The really good, well-done studies ... has more pointed in the direction of "it doesn't work." I think that one of the trials done in the last five years or so looked at a placebo drink and a cranberry juice cocktail drink and the rate of UTI went down in both arms, which would again suggest that hydration was a major factor. That just by hydrating, that is enough to drive down the rate of UTI in this population.

So I think that my study in and of itself, I don't think gives enough information in terms of moving on from cranberries. I do think that there are a lot of other studies though that have already suggested that in other populations.

Eric: Was bacteria plus pyuria the right outcome to look at?

Manisha: The 1994 study, that was the outcome they looked at. And that was the main study that really sent the cranberry industry off in terms of success for UTI prevention. And so one of the thoughts I have was that if we didn't use the exact same outcome that they used and had a positive result, we'd be critiqued for the fact that we had the wrong outcome. So I think that it is a challenge. I think symptomatic UTI would've been the ideal outcome, but the problem is that they're so few and far between that it would've required thousands of patients. So I think it's the best surrogate we have in a population that's very difficult to diagnose UTIs to begin with.

Alex: Great. All right, last question here. What cranberry product, if any, do you have at Thanksgiving?

Manisha: Well I like a bunch of different cranberry products, but I like syrups and sauces and things like that. But I'm open to all kinds of cranberry ... I like dried cranberries in salads. I like cranberry juice cocktail personally. I like cranberry juice in with selzer so. I'll try a number of different things. Whatever's available.

Alex: Eric? Do you ...

Eric: I got a question. Can I continue to eat Craisins?

Manisha: Absolutely! I love Craisins! I mean ...

Alex: Craisins are great, but you know, there's a ton of sugar in them.

Manisha: I tell people all the time, "You should eat ..." I mean see one of the things about the juice and dried cranberries and craisins, things like that, is that you at least enjoy them in the process. The thing about the capsules is there's really not much enjoyment. I mean, the reason you're taking them for a presumed health benefit. So that's my main dissatisfaction with it, and disappointment with it quite frankly. I wanted it to work.

Alex: Yeah, our Thanksgiving tradition is that my mom would open up a can of cranberries, canned cranberries ...

Eric: Ooh, and as it turns around and comes down as one solid ...

Alex: One solid gel mass that then gets sliced into little round circles. That is our Thanksgiving tradition. Cranberry in a can.

Manisha: Once a year.

Eric: Thank you very much for joining us today.

Alex: Thank you so much Manisha. This was treat.

Manisha: Thanks for having me.

Eric: So Alex, do you want to end this with maybe a song about cranberries?

Alex: Sure, so this a song by The Cranberries.

Eric: Ah, I should've known!

Alex: Right, so I think this is called “Linger”. I am unable to sing like The Cranberries. Let's just be clear. But I got a little bit of the chorus.

Alex plays “Linger” by The Cranberries.
Read more »