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Reducing serious fall-related injuries: an interview with NEJM STRIDE Study author Tom Gill


Every year, about a third of older adults fall.  About one in five of those falls result in moderate to severe injury.  What can we do to help not only prevent those falls but also the complications of them?

On todays podcast, we talk to Tom Gill, one of the authors of the recent Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study published in the NEJM.   The STRIDE study was huge, 5,451 patients in 86 primary care clinics from 10 different health care systems.   Individuals assigned to the interventions worked with a “falls care manager” whose goal was to help identify and make plans about risk factors for falls and fall-related injuries. 

What did it show?   Well, the conclusion of the NEJM abstract states that this multifactorial intervention "did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care."   We talk to Tom about whether that is the right take home from this pragmatic study and how should we think about fall prevention in our own clinical practices.



  


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TRANSCRIPT

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

Alex: This is Alex Smith.

Eric: And Alex, we have Mr. Disability on our podcast.

Alex: We have Mr. Disability. We have Tom Gill, who is Professor of Medicine and Geriatrics, and Director of the Program on Aging, and the Director of the Pepper Center at the Yale School of Medicine. This is his second appearance on the GeriPal Podcast. Welcome back to the GeriPal Podcast, Tom.

Tom: Thank you Alex. Thank you Eric. I'm delighted to have a second chance.

Eric: We're going to be talking about your New England Journal of Medicine study, the randomized trial, the multifactorial strategy to prevent serious fall injuries, or the Stride Study. But before we do that, do you have a song request for Alex?

Tom: Right, I had selected Losing My Religion by R.E.M. I know you want a story about that, but I had lots of CD ROM, or CDs, back in the late '80s and early '90s, and I transferred them all onto my MacBook, and that's how I listen to my music is on my MacBook. I have a couple of the R.E.M. albums and I thought, "Oh, that would be a good choice." And then I listened to songs, and gave Alex a few options, and I think we settled on Losing My Religion. I just like the melody, and the lyrics.

Alex: Mm-hmm (affirmative), this is a great one for people to sing along, if you're listening in the car, sing along. It also has maybe a little bit about falls. Consider this, the slip that brought me to my knees failed. Maybe? A tenuous connection?

Tom: I didn't catch that, but I commend you for it.

Alex: Here's a little bit.

Alex: (singing)

Tom: Excellent.

Alex: Love R.E.M., love R.E.M., great choice. Thank you.

Eric: So, let's jump into it. The Stride Study. First of all, congratulations on this study for you and your colleagues. This was huge. How, before we get into the study, how did you get interested in the topic of falls and starting to think about interventions for it?

Tom: Right, well my long-standing mentor, Mary Tinetti is the world's expert on falls, and she'd done most of the seminal epidemiological work, and that led to intervention research in a more traditional efficacy study, and she demonstrated the benefit of a multifactorial approach to preventing falls. It was a relatively small study, the results were published in New England Journal in the '90s, but she didn't have sufficient power to look at injuries. And then she followed that up with a state-based study in which she divided Connecticut into two parts, implemented a similar intervention, more in a real-world settling, and that demonstrated benefit with about a reduction of 8% in serious fall injuries. But it wasn't a randomized trial.

Tom: So PCORI released an RFA. This made it to their top list in terms of priorities, and I was part of a group that responded to this RFA. I think at that point, Mary had moved on to other research endeavors, so she left us to pursue the opportunity that was presented by PCORI.

Alex: That's great, and we should welcome Ken Covinsky back to the podcast. Ken, how are you doing?

Ken: Hi, good to see you all. Hi Tom.

Tom: Hi Ken. Not a good night last night.

Ken: No it was not, we can't lose to the worst team in baseball.

Alex: What is the Cubs' record right now?

Tom: Something like 18-12, or something like that? Ken may know precisely.

Ken: Yeah, I was keeping track for awhile, but then we went on a losing streak, so I stopped monitoring quite as closely. So we're still number one in the NL Central, but we're not, we don't have an .800 record anymore.

Alex: So here's the analogy. Early returns were incredible, right out of the gate, right? The Cubs were, I don't know, 6-1 or something like that. Looked so promising, right? This was a sure thing, just like Mary Tinetti's early studies were incredibly promising.

Eric: Great job bringing it back to falls, Alex. I think Ken thought we were doing a Cubs podcast. [laughter]

Ken: That's right. [laughter]

Alex: So, back to the study. So falls, why are falls a big deal in older adults? Why should we care?

Tom: They're common. So about 30% of persons over 65 will fall every year, and about 30% of those will lead to significant injury. So that's almost 10% of persons over 65 will have a significant injury from a fall in a year, and those values increase with age. So, it leads, at least in our work, our own epidemiologic work, fall-related injuries are one of the most significant, precipitating events in terms of disability and functional decline.

Eric: What do we know, before the STRIDE Study, what did we know about trying to prevent fall-related injuries? You talked a little bit about Mary Tinetti's work. If you kind of had to sum it up, what we knew before this study, what would it be?

Tom: I think it was fairly well-established that falls are preventable, and there are different approaches. There's a literature about different types of exercise, whether it's physical activity or gait and balance, and gait training, generally have been effective reducing falls. And then the alternative approach has been this multifactorial risk factor reduction approach in which focusing on the totality of factors that make an older person susceptible to falls, including sensory impairments, footwear, the environment, medications, in addition to gait and balance problems. So, well-established literature about the reduction of falls, but not ... even the large meta analyses that have pulled the result from the smaller studies, haven't had sufficient power to establish whether fall-related injuries, particularly serious fall injuries, could be reduced from an intervention.

Tom: ... so that was the genesis of, I think PCORI's call for a proposal.

Alex: Mm-hmm (affirmative).

Eric: So that's where this study kind of fits into this environment. Can you tell us a little bit about kind of what you did in this study? How was it set up?

Tom: Right, well, it was quite large. There were 10 clinical sites across the country, from the east coast to the west coast, and there was the data coordinating center and the recruitment and assessment center were based here at Yale. We didn't have one of the clinical sites, and the administrative coordinating center was in Boston. And most of the recruitment and followup in ascertainment of the outcomes was done centrally at Yale. So it was a different model, and this was even pre-COVID, in which the recruitment for nine of the 10 sites was done centrally, and the followup for all the participants, the 5,600 plus participants, was done centrally at Yale. And, that's on the recruitment and followup front. The interventions were implemented at the clinical sites, but they were implemented kind of in real world practices. There wasn't a budget to implement the interventions at each of these sites. We did have support for a fall care manager at each of the site, and this was kind of the ringleader for doing the risk factor assessment to identify the factors that made the participants susceptible to falls and fall-related injuries, and then developing a plan and partnership with the participant that was done by the fall care manager, and then who would then follow the participant over time.

Tom: It was a much longer intervention than we're accustomed to. For those who enrolled early, it was up to 40 months. So, and the followup went to 44 months. So it was very large in terms of number of participants, the number of sites, the duration of followup and the duration of the intervention.

Eric: So you had multiple different sites, the patients that you were enrolled all had risk factors for falls, right?

Tom: That was part of the screening that was done, it was based on three screening questions that whether they've had a fall-related injury in the past year, whether they've had two or more falls in the past year, or whether they're have had ... or, if they're afraid of falling because of a gait or balance problem. So, one or more of those questions, if they were answered yes, was the primary entry criteria for the study, in addition to age. We started with age 75 and older, and over time we had to reduce that incrementally to 73, and then to 70, in large part because these populations were fixed at each of the 10 sites. We didn't have an opportunity to recruit an 11th site when, not surprisingly there were challenges in implementing a large scale trial such as this in terms of recruitment.

Alex: And let's hear a little bit more about the intervention itself. So you had these nurses who were trained as fall specialists, and can you tell us a little bit more about what they did? I understand it was a multi-component intervention. What were the key components of this intervention?

Tom: Right. Well they're fairly standard factors that had been part of prior multifactorial interventions, and one of them is medications. So they were, and I know that's an area of great interest at UCSF, with the deep prescribing network. We probably, if that had been in place before Stride, we probably could've taken advantage of some of the discoveries that will likely be made there. So medications were a big focus; impairments in gait, balance, and muscle strength; there was osteoporosis, was a third area, because we were interested not just in reducing falls, but fall-related injuries, and up to half of the injuries that are related to falls are fractures, at least serious injuries. Posture of hypotension was a fourth area, a fifth was vision impairment, a sixth was home safety, or home hazards, and in fact ... missing one here. Oh, footwear, primarily footwear.

Alex: Right. So critically important areas that we all think about as major risk factors for falls and injury related to falls, and then what, after they'd assessed these areas, what did they do? So, what did the participants do, or what were they asked to do?

Tom: Right. Well, this was what Dave Ruben, who was in charge of the intervention component of the study, called a chronic care model and so for individual participant would identify if there are, which of those seven areas were flagged as being relevant for them, and then they would negotiate and try to prioritize the risk factors, so not try to do everything at once. Try to prioritize. If there were four risk factors were identified, try to identify which ones the participant was interested in starting with. And then they would work together, there was a plan, a series of interventions that were linked to the identification of the risk factor. And these are all fairly standard practices. We didn't develop new interventions, these are interventions that are already available in clinical care. They may not be implemented routinely, but there are standard approaches for postural hypotension, that's often linked to medications.

Tom: And so we just, the fall care manager will work with the participant, try to implement the intervention for the risk factors that were prioritized. And then they would have followups on a semi regular basis. I believe there was at least quarterly, some of those followups would be over the phone. I think the annual assessments were done in person. The initial assessments were done in person, but a lot of the other activity between the fall care managers and participants were done over the phone.

Alex: Ken, jump in here, you got a question?

Ken: Yeah, no, just I think one thing that just seems to ring through with this, Tom, is just the intricate, massive effort of this study. I mean, I think you could teach a whole course on clinical trial design looking at Stride, and just the way you incorporated the best practices of pragmatic trials but also really, everything we know about preventing falls in real world practices, but really moving beyond the kind of typical experimental setting to the real world. So, I can't ... I wonder if there's anything you think maybe, with the post hoc knowledge of the study you would've added, but I don't think anyone ... it's hard to find anything that you could've done better. But I'm wondering if you think there's anything.

Tom: Right, well thanks for pointing out, I neglected to say this earlier, that this was designed as a pragmatic trial because we already know from efficacy studies that aren't necessarily based in real world practice that falls can be prevented. So this was a trial design to see if similar strategies, more in real world settings, could be equally effective. In terms of what could've been done better, we've had a lot of discussions internally about that, and I ... behavioral interventions are challenging to implement. It's not as straightforward as opening your pill bottle and taking a single pill once or twice a day for some period of time. It's not easy to change behaviors, and particularly in this setting with multiple different providers, because the gait and balance, the physical component of the intervention, was really done in partnership with home care services, and outpatient physical therapy groups, and senior programs, and things like that. There wasn't an intervention that the fall care manager implemented him or herself for that risk factor. This is taking advantages of the resources that were available through that clinical site or that surrounding community.

Tom: I think giving patients the opportunity, the participants the opportunity to prioritize the factors, at least to start with, is probably wise, and this being PCORI, we worked in partnership with patient stakeholders both on a national level and each clinical site had their own patient stakeholders committees, and we learned a lot from them. But I think we perhaps weren't as attentive during, as the intervention was being implemented, in monitoring how the intervention was being implemented, as carefully and as closely as we might have done otherwise, given-

Alex: Meaning that you're worried that you may have recommended somebody go take an exercise program, but they may not have followed through and done the exercise program, particularly since you weren't paying for the exercise program, you were referring them to some community class.

Tom: Or in part, that's part of it. I mean I think the fall care manager would monitor that, and then would encourage them, but yeah, there was some limitations on our part of what we could actually do ourself for that specific risk factor. There are certain things, I think there's a tendency probably for the participants and maybe the fall care managers together to focus on the low-lying fruit, things that aren't as difficult.

Eric: Give them some vitamin D, call it a day.

Tom: Right, and that's one thing, and for the osteoporosis, calcium vitamin D, so you can see that that had pretty good uptake. But when we looked at bisphosphonates, not that they're without risk or harm, but they're much more effective in terms of reducing fall-related fractures. So, I think we probably could've done a better job in retrospect of pressing the participants more aggressively to try to reduce the and focus on the factors that were going to be most potent in terms of reducing the outcomes.

Eric: Well maybe we can talk about what outcomes you actually saw. We can talk about kind of what we've learned from afterwards a little bit more. What did you find?

Tom: Right, well the primary outcome was defined as a serious fall-related injury, and that could either be a fall-related fracture, a laceration, or a joint dislocation. That was one set of outcomes. The other was a fall-related injury that led to hospitalization. But even then, there was a finite number of reasons for that. This was an interesting, I know you have mostly a clinical audience, but if we were designing the trial or the protocol, initially any fall-related injury that led to hospitalization was going to be included as the outcome. But as we worked through the details, we realized that that could lead to some bias in that we're working in partnership with the primary ... fall care manager's working partnership with the physicians, the patients' physicians. So, and the fall care manager's obviously not blind to the treatment group, and the physicians wouldn't be blinded.

Tom: So, if a participant had a fall and some type of injury, they would more likely ... we were concerned that they were more likely to be sent to the emergency department, and once you go to the emergency department, the more likely to be admitted, and that would be a conservative bias. So we thought we had to limit the hospital-related injuries to injuries that no one would dispute warranted being hospitalized. We had to omit the ones that could be discretionary, and that's one of the reasons why our outcome rate was lower than we had originally projected. Now that's kind of the backstory, that's not in any of the manuscripts.

Eric: And early on you said about one out of 10 older adults will have a serious fall, fall-related injury over the course of the year. Is that what you found, or sounds like maybe a lower number.

Tom: Well, it's not just, I mean it's moderate to severe injuries, and it's always a challenge to, how do you define a serious fall injury? And there's a lot of different definitions out there, and in the end, we had to select one that was going to reduce the possibility of biased ascertainment, which is often an issue in the context of a behavioral intervention, in which it's not possible to ... blinding is of concern, to the other clinicians that are part of the equation.

Eric: Yeah, so-

Tom: It's probably less than 10%. We were projecting I believe, and it's per 100 the way that the statisticians worked this out was on a per 100 year basis, and I believe the projections were somewhere along the lines of 20 fall-related injuries per 100 person years. And we ended up with rates probably a third of that. And part of it may have been because we had to modify the primary outcome, but also, and this is almost for any trial, the outcome rates are lower than are projected because the outcome rates were often based on epidemiologic studies, and trials notoriously recruit persons that have a lower risk of the outcome of interest.

Alex: Right.

Tom: That's the nature of the beast.

Alex: Yeah. We'll get to who was in the study and do they look like geriatrics...clinic patients, but before we do, I want to ask what the control condition was.

Tom: Yeah, usual care got some education. We had a brochure, we took advantage of the information that was available through the CDC, there's a well-established program called Steady and there are materials that we pretty much pulled off the CDC and we provided them to participants, but they didn't have access to a fall care manager. We also had training for their primary providers, or primary care providers, but that was-

Alex: And the primary care providers also got the result of the risk assessment?

Tom: That's true, but all ... that was in both treatment groups. Yes.

Alex: So, do these patients look, we asked Jeff Williamson this question when we did a podcast with him about Sprint Mind. We said, "Jeff, we did a journal club on your paper, and we looked around the room, and we said, 'Did anybody see any patients like this in clinic?' And nobody saw any patients like that in clinic." And he responded honestly, like, "Yes, this is really designed for a primary care population, the well older adults. How about your study? Are these patients who you might see in a geriatrics clinic?

Tom: I think these patients more so than in Stride, the one characteristic that I think would perhaps not as generalizable was education. About 50% of the participants were college educated, and that's higher than you're probably accustomed to in most settings. That's often the case in clinical trials. But when you look at other indicators of frailty or physical limitations, I believe a third of our participants were using a mobility aid. They had the whole panoply of chronic conditions. A significant proportion had had a prior fall-related fracture. I'd have to look for the details here, but-

Alex: I think one other piece that stood out to me is it's really laudable that you went after people who had cognitive impairment. You didn't exclude them from the trial, as is often done, and yet even by trying to recruit them, I think it was only like 3% or something.

Tom: Right, yeah, you're right, 3-4%. They weren't excluded. We had, again, all the recruitment was done over the phone, so we used the Callahan Cognitive Screen, and if they had four or more errors on that, we had to identify a proxy who could assist on the intervention side of the equation, and in the ascertainment of the outcome of the every four month followup interviews, because we obviously couldn't rely on the participant to accurately report about falls or injuries that they had had over the prior four months.

Ken: Yeah, so Tom, it seems like the intervention really dealt ... if you were to sort of classify the two big probably in primary care practice with respect to falls, the first is that they're not identified. So we're just not trained much to ask about falls in a review of systems, and I think a lot of primary care physicians who are sensitive to falls will tell you that they don't really know what to do when they identify a fall. So it sounds like really, I mean two central features here are that you had a systematic way of identifying either people who are at risk for falls, so fall risk, which of course included a previous fall. But then you really, you had a structure for what to do.

Tom: And that was the kind of the rationale for the a fall care manager. If the intervention led to more robust findings, and then ultimately was shown to be cost-effective, this is a model that could be implemented in real-world practice. You could have a fall care manager responsible for a panel of 200 at risk older patients, and this could be their job, and that was kind of the frame of reference when we developed the intervention was the selection of these 10 clinical sites, they all had their own healthcare system. So this could be implemented in real-world practices without a lot of additional time and effort.

Eric: I think that, one of the things is, I love that. When we look at the results though, the primary results are really negative. There was no difference between the groups as far as first time to serious injury fall. So when I see the results, and I see the ... how am I supposed to interpret it? Am I just supposed to say that a nurse led multifactorial fall intervention doesn't work, so what do I do now?

Ken: And actually Tom, I'm going to ask Eric's question, because I'm very curious, I'm going to ask this question, the exact same question Eric asked in a different way. So, that momentous day when the three PIs of this study got together and results were unsealed, and you found out the results of the study, what was the mood in, I guess it was a Zoom room, but what was the mood in that room? Was it happiness, sadness, oh my God? What was it like?

Tom: I think we were disappointed that the findings weren't as robust as we had expected. And yes, in the traditional sense, this was a negative trial. And that's, we interpreted the results a little differently because the intervention group had some reduction, a much smaller reduction in fall-related, serious fall injuries, than the usual care, or enhanced usual care group to the effect of about a 8% reduction. We were postulating a 20% reduction, and we didn't have the power to detect an 8% reduction, and it would've taken a trial three times the size to detect a reduction that low. So, when we were trying to put these results in the context of prior literature, this is about the size of the reduction that Mary Tinetti had reported in her earlier New England Journal paper for the Connecticut Collaborative Fall Prevention Network, which is not a randomized trial. I alluded to it earlier, in which she implemented this intervention in the northern part of the state, and then the southern part of the state was the control, and it was not, it was an intervention that was more ecologic. It wasn't on a per participant level, and she reported a reduction of about 8%.

Tom: So, and then we took, had some solace in the self-reported fall injury outcome, which was a predefined secondary outcome, and that, the reduction was about 8-10%, and that was statistically significant because the outcome rates were much higher than for the adjudicated serious fall-related injury outcome. And the adjudication process was quite rigorous, and I think that led to a lower than anticipated outcome rate of somewhere, as I mentioned earlier, five per 100 year.

Eric: I'm also trying to think about this like if this was a drug, would this be clinically an important difference? When I look at that primary outcome of first adjudicated serious injury fall between the two groups, the intervention group was 4.9, the control group was 5.3, so a difference of .4 for time to first event. Is that a big difference? Again, it's always hard to wrap my head around in 100 years. How am I supposed to think about that?

Tom: Those numbers aren't based on 100 years, but I mean I think that's a small difference, and it depends on what intervention is necessary to get an effect at that level. And I think the intervention is not, would not be cost-effective for an effect that small. So I don't think we would ... if there was a pill that gave that same reduction, and that's all you had to do? It would probably be meaningful, and maybe cost-effective.

Tom: A behavioral intervention can be much more expensive, and it's very, they're time consuming and it required repeated touchpoints between the participant and the intervention, it was not nearly as easy as Jeff Williams Sprint Study, which you take a pill.

Ken: So Tom, could I ... a thought, and I'd be interested in what your reaction to this, is that one of the things that strikes me about Stride is it was this incredibly well-done study, and it makes me wonder if it's time for the field of geriatrics in our field to have a little bit of introspection that everything was really done well and right. And you could point to a few things maybe you would've don differently, but nothing's been as good as Stride in terms of fall reduction, or for that matter, any geriatric syndrome. Yet, we could not prevent fall-related injuries, at least we couldn't prove it, and even if it was there due to lack of power, it's on the order of a very small amount, like 10%.

Ken: So the thought is, does our field need to be a little bit more humble about the ability to really prevent things like fall-related injuries and prevent fall-related syndromes? And at the same time we're trying to move forward there and keep moving the needle there, also say well, irrespective of fall-related injuries, this is a phenotype of patient where there's lots of suffering, that patients who fall, and their families, suffer a lot, and clinical geriatricians deal with this a lot, and should we focus as much on the palliative aspect of that? So in addition to preventing falls, should the next study on fall prevention also say even if we can't prevent fall injuries, can we prevent the life space constriction that people have with falls? Can we prevent the caregiver stress and the levels of depression patients have who fall? Should we really actually be looking beyond falls itself, but looking more to the wide spectrum of suffering that really geriatricians and palliative medicine providers are expert at dealing with, even if we can't change the fall outcome?

Tom: That's an interesting question. Let me, and I think there's two components to that. First, in terms of what clinicians should do with this information, I think there's a distinction here between what might be done at the systems level and what might be done at the level of the patient and physician. I think on a patient level, I would not want to discourage physicians or providers from trying to work with their patients to reduce risk factors for falls, because I think on a per patient basis, falls and fall-related injuries are preventable. But when you take a step back and try to implement that on a systems basis, it doesn't work as well as we would like, and I think that's an important distinction, and this is an intervention that won't be picked up by health systems. But I think there's useful information here for physicians and other providers in terms of working with their older patients who are at risk for falls and trying to reduce those risks and improve their outcomes. So that's part one.

Tom: Part two, I think you're right that you can also address the consequences of fall-related injuries as part of a more expansive intervention, although that's going to be even more challenging to design and implement, because you're broadening the scope, and to do that from a trials perspective, I think would be maybe a challenge that the UCSF Pepper Center might be willing to embrace. Now we did include other outcomes that were secondary, and they're labeled as wellbeing outcomes, and there's a manuscript under review now providing the results of the wellbeing outcomes, and they pretty much mapped the results of the primary outcome. So, there's no evidence that in an expanded array of outcomes that the intervention provided meaningful benefits.

Eric: That was one of my questions, especially to Mr. Disability, is that you have this group of people, vast majority were afraid of falling on trial enrollment. So we give them potentially physical therapy, exercise, you correct vision, you help with orthostasis, you do all of these things, so maybe they're just going out more and when you're exposed to going out more, to a hazardous outdoor environment in those cities, maybe that's why they're falling more because they're actually doing more. Sounds like that may not be a correct assumption.

Tom: I mean it's a fair point, and a trial like this doesn't have an opportunity to account in that level of detail in terms of the opportunities to fall and be injured. Now, Yale was previously a site for the life trial, and which was a physical activity intervention that was, showed that major mobility disability could be reduced by a fairly aggressive physical activity intervention, and we published a followup report I think in BMJ about fall-related injuries, and whether this physical activity intervention could reduce the likelihood of fall-related injuries. And again, it was a mixed picture that overall there was no reduction in serious fall injuries, but for reasons that we could only speculate on, there was a significant reduction in men, but not in women. And we were concerned in the life trial about the possibility that by making folks more physically active, they would be more likely to fall and become injured.

Tom: Now what we did find is that there was a slight increase in the number of falls, but generally, a reduction in fall-related injuries that was significant for men. Women had some reduction in fall-related injuries, but there wasn't a significant finding. So, it's a valid point, but I think that there's probably no evidence that by increasing physical activity alone you're going to increase the likelihood of having a serious fall injury.

Alex: That's great. I just want to point out for our listeners who may be wondering why are we calling Tom Gill Mr. Disability, that Tom Gill Tweets @mrdisability. Time for one more question, Ken, you got a last question?

Ken: Well, yeah, no, I mean I think I like the way you've been thinking about this at system and patient, individual levels, because I think you're right, the effect may well be different. And I think one thing you are implying is that if ... it's basically the your group at Yale who've basically showed that there's unifying risk factors for falls, functional dependence, incontinence, all the geriatric syndromes have similar risk factors, so presumably if you're trying to prevent falls, you're trying to do other things that are going to be good in other ways so that these ... I think that you're right that this type of intervention is likely to be good regardless. Yeah, but I do wonder though at the same time we're trying to offer physical therapy and trying to reduce the number of medicines, we should also have the social worker involved and teach our patients how to use paratransit, so at the same time we're trying to prevent falls, we're also making sure they can do all the things that are important to them, fall or not.

Tom: Again, I can't dispute that. I think those are valid points taking a broader perspective. Just maybe a final comment about the distinction between systems and patients, about 14% of the participants in Stride who are in the randomized intervention group didn't get anything at all. So they didn't even get that first visit by a fall care manager. That's just the reality of clinical trials. So you take those 14% off the equation, and then you have to account for adherence to the recommendations that were provided by the fall care manager, and that's why these trials, behavioral trials, are just so darn complicated. And that's why I maintain hope and expectation that this intervention, if implemented on a case by case basis when an opportunity to optimize adherence in the context of a patient-doctor relationship has a high likelihood of demonstrating benefits.

Eric: This is my last question for you Tom, is did anything in this trial change your clinical practice? Bringing back down to doctor-patient relationship and how you think about it, anything change there?

Tom: My practice is not a primary care practice, so I can't put myself in the shoes of a primary care provider. I think I have a greater appreciation of the challenges of implementing an intervention that has multiple components, and have somewhat envious of our colleagues who are implementing pharmacologic trials. They have their own challenges, but ....

Eric: But it sounds like from a geriatric syndrome perspective, while it doesn't, from a systems based standpoint, didn't seem to work as we'd hoped. From a patient perspective standpoint, when we're in there with our patients, that we shouldn't lose our religion about the importance of fall reduction...

Alex: There we go. [laughter]

Eric: You like that Alex? [laughter]

Alex: All right, let's just do a little bit more of the song to close it out, and then we'll thank our guests and wrap it up. Here's the last couple verses of We Won't Lose Our Religion.

Alex: (singing)

Ken: Bravo.

Tom: Excellent.

Eric: Tom, thank you very much for joining us on this podcast.

Tom: Thanks for having me.

Eric: Ken, it's always great to have you on. We'll do the Cubs podcast right after this one.

Ken: Of course. Thank you Tom for all this great work, this was a really amazing study.

Tom: And just to let you know I'm visiting Chicago for the first time tomorrow in a year.

Ken: And regrettably, not Wrigley Field.

Tom: Unfortunately not.

Eric: And a big thank you to all of our listeners, for your continued support. If you have a moment, please share this podcast with one or two of your colleagues to spread the news, and thank you Archstone Foundation for your continued support. Good night everybody.

Alex: Goodbye.



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