Project ENABLE is a landmark palliative care intervention. And yet, I will admit (Eric did too) we didn’t really understand what it was. So we interviewed ENABLE founder Dr. Marie Bakitas and ENABLE distinguished protégée Dr. Nick Dionne-Odom to learn more about ENABLE. During the interview, we learned a great deal about ENABLE, how it has evolved, iterated, and shifted over time to include persons with diseases other than cancer, minorities with serious illness, and caregivers. We break the results of ENABLE CHF-PC, a planned plenary abstract presentation for the State of the Science meeting that was supposed to happen next week (here’s a link to the published abstract https://www.jpsmjournal.com/article/S0885-3924(19)30854-1/fulltext).
About that State of the Science.
Well, as you probably know the State of the Science, the AAHPM/HPNA/SWHPN meeting, and the GeriPal/Pallimed pub crawl have been cancelled, for all the right reasons. Er, reason. Covid19.
So sadly, this will not be an oral presentation next week, but you can still here all about it here on this podcast!
We’d like to express our gratitude to the organizers of AAHPM/HPNA/SWHPN and the SOS meeting, including the staff of these organizations, planning chairs, and committees. They put in countless hours preparing for what would have been the largest palliative care meeting of all time. Thank you for all you’ve done!
And yes, Marie and Nick forced me to sing Taylor Swift. Sorry!
Eric: Welcome to the GeriPal podcast. This is Eric Widera.
Alex: This is Alex Smith.
Eric: And Alex, I’m really excited. This is somebody I’ve wanted on for a very long time talking about something called ENABLE.
Eric: ENABLE. Who do we have on Skype with us today?
Alex: So we have two special guests joining us from the University of Alabama at Birmingham. That’s the emphasis there. They get very unhappy when we leave off the Birmingham [laughter]. The first is Marie Bakitas, who’s professor in the school of nursing and co-director of the center for palliative and supportive care at the University of Alabama, Birmingham. Welcome to the GeriPal podcast, Marie.
Marie: Thank you for having me.
Alex: And the second is Nick Dionne-Odom who is assistant professor in the school of nursing and co-director of the caregiving and bereavement support service at the University of Alabama, Birmingham and co-chair of the state of the science, which we will also be talking about, the meeting coming up. Welcome to the GeriPal podcast Nick.
Nick: Thank you so much for having me.
Eric: Big thank you to both of you for joining us. Before we start talking about ENABLE, which is really one of the foundational palliative care multiple studies out there. We all start off with a song request. Do you have a song request for Alex?
Nick: We do. I’m really excited about this. It’s “Shake It Off”.
Alex: Shake it Off by Taylor Swift. Can we ask why you chose this song?
Nick: I’ll tell you why. Because you have forced me to sing by fireplace knowing that I’m a horrible singer. And so this song, the first one that came to mind that I just could not wait to see you play and sing for thousands to see.
Alex: So in other words, this is just pure torture. And you had a couple of other torture ideas. Marie, you were thinking In-A-Gadda-Da-Vida or something?
Marie: Gadda-Da-Vida, yeah.
Alex: Heavy Metal.
Marie: Yeah, Heavy Metal.
Alex: Iron butterfly.
Eric: I’ve always wanted My Milkshake Brings All The Boys To The Yard-
Alex: Which we did for our hundredth episode. Pure torture [laughter and sympathy]. And there was an attempt to get us to sing Sonny and Cher, I believe.
Eric: Oh, was there?
Marie: The beat goes on. Like the very for, heart failure, like themes-
Alex: Oh yeah, that’s good, but that just wouldn’t have worked.
Marie: I don’t know. I think it would have.
Alex: Well maybe if we have you on again. We’ll see. Okay. Taylor Swift. Here we go. You got to hit that button. There we go.
Eric: He loved that. I can tell that Alex loves singing this song.
Alex: You could tell?
Eric: Yeah. You like that song.
Nick: That was by far my favorite moment of the week [laughter].
Alex: We’ll sing that in person next time.
Nick: I can’t wait. I know I’m not singing.
Alex: So first topic we wanted to address is state of the science.
Eric: State if the science. What’s state of the science?
Alex: This is coming up next week, right?
Eric: Next week.
Alex: So, we’re pushing this podcast out a week before the state of the science as a way of hyping it up to our listeners. By this point many of you have probably either registered or not registered and maybe some of you want to do some last minute registration. But we wanted to hear from Nick who’s co-chair of the state of the science, a little bit more about it. What is this meeting? This is first time this is happening in conjunction with the Academy meeting. Who’s it for, what should we be excited about?
Nick: So, state of the science will be an inaugural symposium that’s led by HPM and is a two day conference targeted at palliative and hospice care, researchers of all stripes to really create a space to do three things. Number one, promote further dissemination of our science across all career stages, two, to really promote networking and collaborations amongst our community, and three, to promote mentor mentee relationships through end person contact. So really those three objectives are the primary motivation.
Nick: And the conference features a lot of presentations that will be focused on cutting edge research with specific concentrations and the research methods and how things were done.
Alex: And what are you two most excited about in terms of the state of the science meeting?
Marie: Well, I’m super excited about all the opportunities to network and to hear about really great findings. I’m also super excited that once it’s over, Nick will get a night’s sleep, not worrying and planning. There’s so much planning that’s gone into this and a lot of excitement. So I’m excited about those two things for sure.
Alex: And we should mention … Oh yeah, Nick, go ahead. What are you excited about?
Nick: I think I’m really excited about those early career folks out there who really want to connect with people in the field who they’ve only seen on paper and they’ve really just wanted to meet in person or they’re really looking for some direction in life career-wise, work-life balance wise, and really can’t wait to hear stories of hopefully them finding it or at least hopefully them making a little bit further headway.
Alex: We should mention that Nick has had a partner in crime is the wrong word, but as co-chair he’s worked closely with Abby Rosenberg who at the University of Washington in Seattle as the other co chair of this committee. We’d love to have Abby on this podcast at some point, but she studies pediatric care of patients with cancer-
Alex: So for geriatric palliative care podcast, that’d be a stretch. But thank you to you, Nick, to you and Abby, both of you for doing so much work and organizing this first conference.
Nick: Yeah, special shout out to my partner in crime, and she would be great to have on geriatric podcasts because I’ve tried to express in writing many of the challenges and issues that happen with young adults are actually quite similar to older adults. So I think that actually-
Alex: That’s our tenuous link.
Nick: That’s the tenuous link.
Eric: It sounds like you’re also going to be talking about a lot of new interesting studies in palliative care, and one of them that we wanted to talk about was ENABLE CHF-PC. Is it slash PC, is it just PC?
Marie: Yeah, PC.
Eric: So just PC. But before we talk about kind of a little bit about … Oh, Siri is talking-
Alex: Siri wants to join the podcast [laughter].
Eric: I am not talking to you Siri. Before we talk about ENABLE CHF-PC, I just love to take a step back, because ENABLE’s been around since what, 1999?
Marie: 1999 was the birth of ENABLE.
Eric: And I remember going back to a GeriPal post in 2000, I think 15 or 16, there was a New England journal article that came out by Scott Halpin and it said, but one of the most sobering facts is that no current policy and practice designed to improve the care for millions of dying is backed by the fraction of evidence that the FDA would require even on a relative innocuous drug. And I loved in that post, Marie, I saw your name pop up and actually commented that we actually had at that point, a lot of evidence thanks to studies like ENABLE.
Eric: Can you kind of walk us through the development of ENABLE and that multiple different trials that you’ve done around this?
Marie: Sure. Probably the clinicians would be interested to know that, we were trying to do palliative care for a while in the acute care hospital. But it wasn’t until we got an acronym that we got funded.
Eric: Yeah, like cardiology, right?
Alex: Yeah. Taking a cue from cardiology.
Marie: Yes. And so ENABLE stands for educate, nurture, advise before life ends. And that was the acronym we used for the first study, which was a demonstration project in three rural sites in New Hampshire and Vermont and was funded by the Robert Wood Johnson promoting excellence and end of life care. They put that effort forward after their support study that showed that things in care hospital at end of life were not very good.
Marie: And so they put their money where their mouth was and they funded 23 programs across the country, to look at different ways to bring hospice principles earlier into the trajectory of illness. So that’s what we proposed was, we came at it with the idea that the World Health Organization said, “You should be doing palliative care at the initiation of a new diagnosis of cancer.” And the analogy we use was, if you’re going to have a baby, you don’t wait eight months and 29 days before you say, “Oh, I’m going to have a baby. Maybe I could do something about that. Prepare a room, or know what’s going to happen.” And so, like childbirth, we said, illness was kind of the same thing and that we needed to be prepared for what was going to happen next.
Marie: So that’s kinda how we got to ENABLE. The most important thing I think is that we went to clinicians and patients and family members and asked them, “What do you really wish you knew at the time that you were diagnosed that would have helped you go through your cancer?” And so they told us all of the list of things that, had they known, they wish that things could have been better, et cetera. And that’s where we got the idea for the topics that are part of ENABLE, which by chance end up being the same essential elements that palliative care promotes. So that’s symptoms and physical wellbeing, psychosocial or emotional wellbeing topics. Problem solving is like how to deal with issues, communication and advanced care planning is part of that.
Marie: And then this thing called life review. And that was a component we added afterwards where they didn’t want to necessarily always just think about having cancer. But cancer is just like a snapshot in the video of life. So we wanted to really focus on their life trajectory without cancer too.
Eric: And ENABLE’s, changed a little bit over time. In that first ENABLE one study or I guess just ENABLE, what was the actual intervention? Who was delivering this intervention?
Marie: It was actually in person, and it was delivered by a nurse coach, kind of like, we had this little joke like Lamaze for lymphomas. It was like a childbirth model. So people who’ve had children have come in for various sessions to learn how to be prepared for the birth and after the birth and so forth. And so we had these sessions in the cancer center with patients and families, and we sort of covered these topics. It was mostly an advanced practice nurse who had oncology and some palliative care training. But we had chaplains and social workers come in, somebody from finance to talk about, people were always worried about billing and how to pay for their treatment.
Marie: So we had a host of different people come. A nutritionist came and presented. So we had a host of different people come on these various topics.
Eric: And ENABLE, what did you actually find in this study? Did it work?
Marie: Yeah. Did it work? It’s an interesting thing. Because again, it was a demonstration project, so we did it in a small rural clinic way up North in Berlin, New Hampshire, and then down south in the urban center of Manchester, New Hampshire. And then, in Hanover where Dartmouth was, which again was very rural. And we found that it was feasible. People said, “Oh, the oncologist, they’re not going to want their patients to do this.” We actually had no conflicts with the oncologists. They were all recommending patients come. And so in a year and a half, we managed to enroll 380 patients and their family members.
Marie: The big problem was that we could not get everybody to come for the session. And we felt committed for them to get the information, and so we started calling them up and doing it one-on-one by phone. And when this data we use as our preliminary data for what became ENABLE II, we decided why go through that hassle of trying to get people there, we’ll just do it by phone. And that’s when we converted to phone based intervention.
Marie: Halfway through ENABLE II, we had such a thing as called a palliative care consult team. And so then we started having them meet the consult team to do that initial assessment and then go through the rest of the sessions by phone.
Eric: And who was on that palliative care consult team? Was it just one person was an interprofessional team?
Marie: It was just either a nurse practitioner or a Board Certified Physician that did the initial intro, but there were others available if they it seemed like a need. And usually the nurse coach on the phone referred them to further in person services if they needed them from chaplaincy or whatever other members of the team.
Eric: So they saw the whole team, they were followed by this nurse coach. If symptoms arose, like untreated pain, did they go back to the palliative care team?
Marie: Well if need be, for sure. The answer is yes, they did. And they had met them early on, so it wasn’t really a big deal. It’s like you remember those people that you saw, early on from palliative care? Well, maybe they could be helpful. But we really encouraged the patients to be empowered to bring these issues to their clinicians, their oncologist and the oncologist would refer them. But occasionally we would call on their behalf if we had a patient that we just felt like, with their permission of course.
Marie: But one of the really important pieces that we missed out on or we didn’t really think through for both the demonstration project and ENABLE II, we always had caregivers around, but they were just like always around. It wasn’t as though we had something specific that we were going to do for them. And so, thank goodness Nick came along and had an interest in caregivers. We finally wised up because, our first study, the first randomized trial we looked at caregivers, we did some measures, caregivers to see how they were. But really what we wanted the caregivers around for, it kind of sounds bad to say this, but patients can’t always report towards the end of life, especially how they are. And we wanted to get a sense of that, and so we did after death interviews with them. So we engaged caregivers along the way as sort of an add-on, but not really as a focus.
Marie: And so that’s when Nick came along and we wised up and found that the caregivers that we were treating in ENABLE, that we really were treating it ENABLE II, that those caregivers were not benefiting. And in fact, the ones in the intervention group might’ve been a little bit worse off in the few measures that we did with them. Simply because here we are activating these patients, and we’re getting them, raising their issues and concerns, but we’re not doing any sort of parallel support for their family caregivers. So they might be like, “Whoa, who’s this person speaking up or whatever.”
Eric: It sounds like that led to ENABLE III. But before we go to ENABLE III, this was published in JAMA – ENABLE II right? This was-
Eric: I’ve heard of that journal.
Marie: I think you might have heard of it. Nick’s heard of it too.
Eric: Real quickly, what did you actually find as far as maybe not for the caregivers, but for the patients? Did it help the patients?
Marie: Yes. Well, of course I’ll point out it was the lead article on August 9th 2009 in JAMA. And what we found was the patients had improved quality of life compared with people who did not have the intervention. They had less depression or improved mood as well as a longer survival.
Marie: And you might ask the question, “Well, gee, we’ve heard a lot about Jennifer Tunnel’s paper and the survival issue.” well we didn’t actually put survival as an A priority outcome. So we weren’t planning on looking at that. We weren’t really powered to look at survival, but the survival was actually almost six months longer in the intervention group than that. So they let us put this teeny weeny little graph on the last page of the paper. We couldn’t say anything about it in the actual abstract because, JAMA has pretty high standards because it wasn’t an A priori thing we were going to look at.
Marie: We had been contacted though by the Associated Press, and we did some initial press, but the day that the paper came out was the day that … Do you all remember Sarah Palin?
Eric: Who? Oh. We were just teaching my 11 year old son about Sarah Palin yesterday.
Alex: Yes. We remember Sarah Palin.
Marie: Yeah. It was motivating that these things like palliative care were akin to death panels.
Eric: Oh, the death panel phase …
Marie: And so, the whole news cycle pivoted. So you can go back and look up what happened on August 9th with death panels.
Eric: I love that you remember the dates. It’s so clear.
Marie: And I’m not bitter at all [laughter].
Eric: Not at all. Well … Okay. ENABLE III. ENABLE III right? Now we’re starting to include caregivers, is that right?
Marie: Yeah. I would love for Nick to give his version of ENABLE III.
Nick: Because there are so many versions. ENABLE III was a waitlist controlled trial where we actually looked at the timing of early palliative care. What that means is the one group started right after enrollment, and one group waited 12 weeks, and this was within 60 days of new diagnosis of advanced cancer. And this is, caregivers were assigned to the group that patients got. And their curriculum was in some ways mirroring the patient curriculum. They had their own nurse coach. They received also a series of weekly sessions over the phone lasting 30 minutes or so with topics including their role as a caregiver and what is palliative care, how to partner with patients in self care, how to partner with patients and symptom management, communication and advanced care planning.
Nick: And those were the three main topics that were discussed under the caregiving version of the ENABLE III trial. ENABLE III for patients included all the stuff from ENABLE II and the outlook intervention developed by Karen Steinhauser, which is a legacy intervention where patients are asked to sort of reflect on their life story, to think about aspects of their life related to forgiveness and also to think about aspects of their life related to legacy and specifically things they would still like to do.
Nick: That was followed by monthly follow up for indefinitely actually in that trial. And the early versus delayed group comparison for patients did not demonstrate any impact on patient reported outcomes. However, there was a survival advantage in the patient group, and the reasons for that were likely due to Dartmouth having greatly advanced in their palliative care capacity after the ENABLE II trial, meaning that the level of palliative care for all cancer patients at that time is extraordinarily high and which may have explained the [crosstalk 00:23:54]-
Marie: So we sort of looked back and looked at this thing called contamination, and it turned out that half of the patients in the arm that was supposed to be not starting for 12 weeks after diagnosis, so half of them got a palliative care contact before they should have. And so it turns out that they had exposure for a lot of the symptoms things and so forth before they should have. I think that nobody across the country, when I would tell the story, believed it, but when we proposed this design, because we had already demonstrated, it wouldn’t be ethical to withhold palliative care when we’d already shown that it was a benefit in so many ways for patients. We proposed this design so that we would have that rigor of having a randomized trial with this delayed arm.
Marie: And it was the surgical oncologist, the GI surgical oncologist who did a lot of pancreatic cancer surgeries said, “Are you kidding me? I have to wait 12 weeks to get my patient on palliative care?”
Eric: I love that.
Marie: It was crazy.
Alex: You know you’ve made it win.
Eric: So, patient outcomes like quality of life, symptom burden, mood didn’t show a difference. And I can imagine contamination may be a reason. This was not palliative care versus placebo. You can’t say palliative care didn’t work because people were getting palliative care. What about survival? That was a primary outcome in this study, right?
Marie: That’s right. This time we powered for survival. And we speculated a lot of different reasons why survival still would have been better in the early group. And that’s because some of the things that we taught people about was, we did a lot of decision support. And so people made choices about their treatment. They were prioritizing their own preferences and values. And so, it’s possible that some of the things in ENABLE that didn’t have to do with the symptoms per se, were the active ingredients for the survival advantage.
Eric: And real quickly, the palliative care part of this. There was a palliative care team that they saw, there was the nurse coach. So all the kind of components that you kind of built on over ENABLE I, II kind of led to III.
Marie: Right, right. And-
Eric: And the caregivers.
Marie: And then the caregiver piece, which was really critical. And actually though, even though the patients didn’t show a difference, the caregivers did. Nick, you want to comment on that?
Nick: Yeah. Usual care for caregivers is virtually nonexistence, so real formal direct support per se. And so what we did find was that early group caregivers at 12 weeks before the delay group had started demonstrated benefit to both their mood and their stress burden. We also did an analysis looking backwards in time from patients’ deaths 36 weeks and found even more impressive effect size differences in those early group caregivers. And that’s even after the delay group caregivers had still gotten a version of early palliative care. So really impressive results there.
Nick: We also published exploratory findings looking after death to look at grief from bereavement outcomes. And while not statistically significant, there was a clinically appreciable effect size difference, benefiting the early group suggesting at least the hypothesis that early palliative care may in fact affect post-death caregiver grief and bereavement outcomes, which we thought was really impressive and which we’re still figuring out ways to measure in our current clinical trials, just given that the timeline and the difficulty of doing that type of trial.
Alex: This is terrific. And at this point, I don’t know if this is the point where you moved to Alabama, but at this point is you’re leading into ENABLE IV, you’re thinking, we’ve conducted this primarily I’m assuming in a largely white populations in the Vermont, New Hampshire area and you decided to expand to a more diverse area in the South. Is that kind of the thinking that went into ENABLE IV?
Nick: Everything is clear in retrospect.
Marie: Yeah. I fell like it was a good idea in retrospect, but it turned out that we actually started our heart failure work at the same time we were doing ENABLE III as a pilot, and that was based on some clinical experiences where we were getting really late heart failure referrals. And so we did a retrospective look at … And this was, I guess back in 2011. We did a retrospective look at how many heart failure patients had a palliative care consult, and it was only about 10% of them.
Marie: And so we partnered with one of the Dartmouth heart failure, the head of advanced heart failure program. He was really gung ho on having palliative care involved, and involved way before people were in the unit and, stuck in all kinds of event or on inotropes or on stuff that they had never really had a chance to make a decision about. And we said, okay, well, let’s see if we can translate what we were doing in cancer into heart failure.
Marie: And so we did some focus groups and we met with some patients and we said, “Hey, we’ve been doing this thing in cancer. We know heart failure is really different. Help us to know how would we apply this information for heart failure group?” And so we did two pilot studies. The first one was done at Dartmouth. And at that point is when we were recruited down to UAB. So when we got the pilot study funding from the national palliative care research center we did the pilot both at Dartmouth and down in Alabama.
Marie: And we learned a lot from that pilot study. It was approximately 30 patients and caregivers at each site. And we learned that you cannot do the same thing in the North that you need to do in the south.
Alex: Say more.
Eric: Are we talking about that primaries? No.
Marie: There are a lot of things that are different in the North and the South come to think of it. I hadn’t noticed before until you pointed it out. But for sure in the heart failure study, there was much more involvement with spirituality and religion in people’s … And I don’t want to say that up North is a bunch of atheists or agnostics, but in our religion is spirituality measures much higher. And then in empowerment, we had a patient activation measure, typically much more activated up North versus down South. And then there were literacy issues that we hadn’t picked up as much of up North that were definitely those.
Marie: So we changed all of our materials. certainly there was a trust issue. People trusted UAB, so we made sure we branded everything very clearly. This was a UAB program. So those were some of the things.
Marie: And also for caregivers there was a difference too.
Nick: Yeah. Just sort of very much in sync with a lot of those patient differences. Just more at a higher proportion of African Americans. The number of Protestants by proportions was way higher in the deep South-
Marie: Versus Catholics.
Nick: Yeah, versus in New England. And so there was certainly a difference though. The caregivers in the South younger and to be a non spouse. Which is a little bit different of a caregiving situation in spousal relationships which tend to be the most prevalent at least in cancer and heart failure.
Alex: Seems there’s a really important lesson here for people who might want to take the ENABLE intervention as ENABLE intervention is disseminated across locations, that there’s a need to adapt it and refine it for your local setting and for the needs of the particular patients that the people serve in the new setting.
Marie: Yeah, that’s definitely true. Because we’ve learned this lesson about the need for translation to different diseases and different cultures, we’ve been very strong advocates of any intervention that you’re doing, starting with bringing the patients in the community onto your team and having them advise you.
Marie: And I think we were really clear with the patients that were doing the heart failure studies by saying, “Look, we don’t want you just to tell us, this is great.” Because there’s probably a tendency to just want to be pleased by the researchers. But we’re like, “What you say and do and tell us is going to affect future people. And so if you tell us that something is great and it really isn’t, it’s going to impact people in the future. So we want you to be our co-researchers and be brutal. Don’t try to please us. Please tell us the things.” And they did. They told us the writing was too dense in the book. And they didn’t want to focus so much on this area, they’d rather focus on another area. And so I think we got really good advice.
Eric: So at the state of the science, you’re going to be presenting the abstract on ENABLE CHF-PC-
Alex: Which stands for Congestive Heart Failure Palliative Care, right?
Marie: No [laughter].
Marie: No. We don’t use the congestive part.
Eric: It actually doesn’t? [laughter]
Alex: No, I thought it did too. Sorry. Go ahead.
Marie: So it’s stands for Comprehensive Heart Care for Patients and Caregivers.
Alex: For patients and caregivers. That’s good. Yeah. So what did you do in ENABLE CHF-PC, and it could you give us the findings of the abstract you’re presenting at the plenary session of the state of the science and in a sort of a nutshell.
Eric: What day is it?
Marie: Am I allowed to do that Nick?
Nick: We’re not under any topic-
Eric: What day is the plenary?
Alex: It’s Saturday?
Marie: Saturday morning, right.
Nick: March 21st.
Alex: All right. March 21st, Saturday morning.
Eric: And you can talk about abstracts, just like if they press at say the science and they want to talk to you about your abstract, they can talk to you about it?
Marie: Yeah. Well, for the presentation there, and also the caregiver data is being presented at the academy meeting. And that’s actually already impressed, the caregiver data. I’ll hold that one back for just a second.
Marie: The essence is that we had 415 patients, more than half of whom were African American, which was probably the largest study of heart failure palliative care in a diverse population. And we did not find statistically different outcomes of quality of life and mood, which are primary outcomes. But we did find statistically improved pain intensity and pain interference, which was a secondary outcome in the patient population.
Eric: This was a randomized controlled trial of the ENABLE intervention versus usual care?
Marie: Usual heart failure care. We learned a lot of lessons from this trial. And again, as I said, the difference between cancer and heart failure and the difference between North and South. We learned plenty of lessons with the pilot. But here, one of the big issues we had was tracking people down by phone.
Marie: Over time, people don’t answer their phones anymore. And I think it’s-
Eric: Right. We’ve got to text them.
Marie: … Fell victim to telemarketers, honestly. Because, we would work really hard with patients and say, “We’re going to be calling you from this particular number, from this particular area code, and this is the time and so on and so forth. And there was a fair number of people that it took a lot longer to get them. And secondly, that in-person console, you figure, well, people with cancer are coming regularly to clinic because they’re getting treated. Not so much with heart failure. People lived far away. And getting them to come for that one face-to-face appointment was really, really difficult. Actually, only half of the people in the intervention group actually were able to adhere to that part of the protocol and come for the appointment with palliative care.
Marie: And, two thirds of the patients did everything they should have done in the protocol. So, we’re wondering whether or not there was this dose effect, like they just didn’t get enough of it to have that quality of life effect.
Marie: The other thing that we found out was that the patients that we enrolled were much less sick than in other heart failures studies that had found positive outcomes. And so basically people came in at baseline with a score that was equal to what the other studies groups improved to. Not for people to be aware, but 50 is like a cutoff score. If you’re above 50, you have a good quality of life and if you’re below 50, it’s a poor quality of life in this one heart failure tool that many clinicians will know the Kansas City cardiomyopathy questionnaire. And it turns out that more than half of our people were above 50. And they have advanced heart failure, so they don’t really have anywhere more to go in quality of life. So that’s kind of why we thought maybe we didn’t see such a difference there.
Eric: What about the caregivers?
Nick: For the caregivers, those findings actually are under embargo.
Eric: All right. Never mind. They were caregivers and we will find out soon.
Alex: You can give as a preview of the methods if not the results.
Nick: Sure. So again-
Marie: It’s going to be published in JAMA network open.
Alex: Great. When is it coming out? Do you have a date?
Nick: I think it’s an April. They were going to try for the conference, so they couldn’t do it that fast. So it should be coming out in April. It was the same research design caregivers were assigned to the group that patients were randomized to. Less numbers. It was 160 something caregivers, albeit it’s already the largest caregiving trial and heart failure to date. Also the most racially diverse, as over half were African American. So a number of strengths of the trial.
Nick: And, the intervention itself was very similar to what we had done in cancer. It was a series of nurse coach led phone sessions that palliative care topics that had been tailored for heart failure, including their role as a caregiver in heart failure, what is palliative care, communication, decision making, symptom management in heart failure or self care in heart failure. We had four sessions as opposed to three in cancer, where we focused a little bit more on values and the role they play in decision making.
Eric: So we’re not going to push you on the results, but I wonder, thinking about the ENABLE CHF-PC study, if I’m starting a palliative care service in a heart failure clinic, are there any kind of big lessons that I should be learning about from these studies?
Marie: I think one of the major lessons is that especially if you’re in a rural area, we can’t be locked into geographic clinics, because you can have these sensitive conversations and establish rapport without having that in-person connection. And in fact what we found was that some people seem to be actually revealing and disclosing more, because they had that little bit of distance where it might’ve been difficult for them to share some things face-to-face.
Eric: And are you using any video conferencing or just telephone?
Marie: Because of our lack of really good broadband coverage in the mountains of Vermont and here in the area, we hadn’t been for ENABLE, but we are trying it in some hospital-based palliative care in rural hospitals that we’re doing now. So we are going to be incorporating video there. We’d like to, but patients just tell us. I mean Nick did a study with caregivers and that’s basically what they said.
Nick: Alabama like a lot of …. Some of them it’s the poorer states have numerous counties without broadband access period, which means that even if we gave them a tablet, they still wouldn’t be able to really use that device to participate in any of these studies. And so that’s a real sort of infrastructure limitation to some of the palliative care that can be delivered outside of an urban setting or a more resource rich environment.
Nick: Another comment about clinicians wanting to implement early palliative care like ENABLE is the real importance of identifying a population that needs it most. When we did what’s called a sensitivity analysis, which is analysis where you kind look after you’ve done a study, you didn’t say you’re going to do it up front. When we looked at those patients in this heart failure trial who actually were really sick as indicated by the KCCQ or that quality of life measure, we noticed it actually did have an appreciable effect.
Nick: For those out there interested in p-values was like 0.051. And it was a very good effect size, clinically meaningful and suggesting that had we had a sample of really sick patients, this intervention would have in fact demonstrated efficacy. But because it was not our primary outcome, we have to remain reserved with that conclusion. But that is what it showed.
Nick: And so for a clinician interested in implementing this care, I would say developing mechanisms to identify those patients who are most need. And I’m sure that many people watching this already have very tapped out palliative care service lines. I’m sure their personnel are already maxed out. So to make most efficient use of our specialty services, I think identifying those at most need is important.
Marie: Yeah, definitely.
Eric: Real quickly before we end I’ve got one more question, what’s next for you?
Marie: Can we say that quick way? Let’s see. So we’ve been pilot testing in COPD. Nick’s working on lay navigation. And so, a lot of people don’t have the resources of Board Certified folks to do palliative care. Do you want to talk about lay navigation?
Nick: Just quickly. Given our strained palliative care specialty workforce and knowing that family caregivers would represent, a virtual doubling of people that we’re trying to service, we really need to tap into another workforce if we really want to get serious about offering some measure of formal support. And so I’m really trying to work with models of lay. Lay folks or community health workers, lay navigators who can really deliver at least a first line level of screening and support services as a way to deliver this type of early palliative care.
Alex: That’s terrific. We’ve done a number of podcasts with folks who are using lay health navigators, including Tracy Fisher and Regina Fink who are using Latino lay health navigators in Colorado and in the care ecosystem here at UCSF for patients and caregivers with dementia.
Eric: I want to thank both of you. I’ve got one more question. Let’s say I’m really interested in bringing ENABLE into my medical center, how do I do that? I know how to implement a palliative care service, but what about layering ENABLE onto that? Are there guides, is there meetings?
Marie: There are guides. Actually, we’ve just been funded to bring ENABLE into 48 cancer centers that don’t have palliative care actively in the outpatient setting. And so we’re using two different implementation models. But it was one of the big concerns is, can you do it anywhere? And really, we have training materials. If we were contacted, we would be happy to help you figure out how to do it. But it’s not difficult.
Marie: And for those places that are doing … Obviously you know how to do consults, which is one part of the intervention. The other part is just doing the series of phone-based sessions. And so if you’re interested in tele-health to expand your access, that’s really all that you need. So it’s pretty straightforward.
Eric: Great. And we’ll have a link to the UAB project ENABLE website. I’m guessing there’s more information about who to contact on that site? It looks like it’s your name Marie.
Marie: You bet. We’re working on sharing the wealth a little bit, but yeah, at the present time, that’s what’s there.
Marie: Eric, can I just mention that it has been translated into work in Honduras, Turkey and in Singapore.
Alex: Wow, that’s wonderful. That’s terrific.
Eric: Well, I do want to thank both of you for coming on with us. But before we end, maybe we can hear a little bit more of Taylor Swift.
Alex: Yeah. We just want to say thank you to both of you, Marie and Nick, really enjoyed having you on and learning more about ENABLE. Here’s a little bit more of that torture Taylor Swift song.
Eric: You’re doing it better than Taylor [laughter].
Eric: I just want to say to everybody, Alex is pretending not to know the lyrics, but he listens to the song every day.
Alex: Yeah, right.
Eric: I hear Swift coming out of his office daily –
Eric: Again, big thank you to both of you for joining us.
Alex: Thank you.
Eric: Thank you to all of our audience for supporting the GeriPal podcast.
Alex: Thank you to Archstone foundation for funding us.
Eric: Goodbye everybody.
Alex: Bye everybody. Thanks.