Who Should Deliver Palliative Care in Liver Disease? Chris Woodrell, Manisha Verma, Marie Bakitas

Eric 00:13

Welcome to the GeriPal Podcast. This is Eric Widera.

Alex 00:17

This is Alex Smith.

Eric 00:19

And Alex, we’ve now done several episodes, I believe, on liver palliative care or palliative care and liver disease. Today we’re going to be talking about a JAMA article titled palliative Care Intervention for Patients with End Stage Liver Disease, a cluster randomized controlled trial with three of its authors. Who do we have with us today?

Alex 00:36

We have Manisha Verma, who is an internist and researcher and director of research in the Department of Medicine at Thomas Jefferson University. Manisha, welcome to the GeriPal Podcast.

Manisha 00:50

Thank you. Thank you for having us.

Alex 00:52

We have Chris Woodrell, who is a palliative care doctor and researcher and associate professor at the Icahn School of Medicine at Mount Sinai. Chris, welcome back to the GeriPal Podcast.

Chris 01:03

Hi. Thank you.

Alex 01:04

And we have Marie Bakitas, who is a nurse, researcher, is retired professor and associate director of the center for Palliative and Supportive Care at the University of Alabama, Birmingham. Welcome back to GeriPal.

Eric 01:20

Hey, so before we talk about this article and in general, how we think about palliative care and liver disease, who has a song request for Alex? Manisha, is it you?

Marie 01:32

Yeah.

Manisha 01:33

So, Mr. Wallingley, thank you, Eric and Alex, for having us. The song request we have today is Slipping Through My Fingers by abba.

Eric 01:42

Why did you pick this up?

Manisha 01:44

I felt this song is really resonating with what we have accomplished so far and particularly the advisory board members. This study involved patients and caregivers. Those advisory board members really reflected on the passage of time, cherished relationships, and moments they wished to kind of be together. And above all, I really want to dedicate this to my father, who I really lost before I entered medical school. So it was a really tragic event. But his motivation, his passion, his way of living has really shaped me. So I really want to dedicate this to him because I’m sure he’s very happy with the outcomes and where we are at this point in life. Thank you.

Eric 02:24

And are you an ABBA fan?

Manisha 02:26

Not too much, but okay.

Alex 02:29

I think this might be the first ABBA song in over 400 requests.

Eric 02:34

No way.

Alex 02:35

Yeah. Congratulations, Manisha. I think you’ve hit upon a new artist that we haven’t done before. Here’s a little bit.

Alex 02:46

(singing)

Eric 04:11

Wonderful. Now we gotta have more ABBA on the podcast.

Alex 04:15

Careful, dear listeners, those are tough to play with solo guitar, but you can request it’ll probably sound a little different than the original. All right, thank you.

Eric 04:24

Thanks Manisha. Marie, Chris, Are you either of you ABBA fans?

Chris 04:28

Casual ABBA fan.

Marie 04:33

I like Australia.

Eric 04:35

Okay, we’ll have to have you back on. Well, we’re not going to be talking about Abbott this podcast. We’re going to be talking about really wanted to talk about this study that you did. So Manisha, I’m going to turn to you. Why did you decide to do a study looking at palliative care specialists versus hepatologists trained in somewhat in palliative care? Why did you decide to do this study?

Manisha 04:59

I think that takes me Back to like 6 years ago when we proposed this study. Right? You’re like why this study is the first important question for so we really undertook this study despite really. Because I think the really important part is the symptom burden and the psychosocial challenges among patients with advanced liver diseases is under recognized. There is lots of studies which have proven that there is a high burden among this population. But there are no you would say interventions which have addressed these. So there is limited evidence on palliative care in this population.

So this is a chronic complex progressive illness where there are usually at the terminal stage either it’s death or a transplant. Now transplant is not in your hand, organs are limited. So the decision making is very very complex for this patient population. And despite clear evidence we all know panic care improves quality of life, improves symptom burden, improves decision making on many non cancer serious illnesses. And why not learn why are these people getting delayed quality delayed interventions and above all there’s only seven there’s data that shows less than 10% of these patients receive palliative care and that too within six hours of death.

But that’s futile. So we wanted to do an early intervention for this patient population and address some of the major barriers in current care and, you know, designed these two beautiful models and conducted a comparative effectiveness trial.

Eric 06:32

All right, I got a question. I’m gonna turn to you, Maria, on this. Just because you have a tremendous Both having done studies around palliative care and just an incredible knowledge about this. What are your thoughts? Like, if I go to a cardiologist, I don’t have to see that a cardiologist has done that. We have randomized control studies of cardiology controlling atrial fibrillation or cardiology and management of heart failure or cardiology and the management of even hypercholesterolemia.

But we have patients go to cardiologists all the time for these things. Do we need randomized controlled trials of palliative care in condition X, like palliative care in this case liver disease, or palliative care in different types of cancer? Palliative care and als. Palliative care. And what are your thoughts on that?

Marie 07:18

Yeah, I don’t think we do. But guess what? We are not going to get those patients seen or those clinicians convinced unless the palliative care study is done in disease A, B, C or N D. Because everyone turns around and says, well, just because it works in cancer, you know, advanced liver disease is way different than cancer, although, you know, HCC is part of that. Right. So I think it’s a matter of more convincing the clinicians who refer and the patients who will and caregivers who will benefit.

Eric 07:59

Do you agree with that, Chris?

Chris 08:01

Yeah, and I think we are having a conversation a lot as a field about palliative care versus usual care. In this case, that’s not what was done. It’s palliative care delivered by the specialist team or by hepatologists who received the module training, depending on what site you were at. I think that, you know, in this case, everyone in the study received some sort of palliative care. And this was also an opportunity for Manisha and Vigil Navarro, the PIs, to take part in that, you know, palliative care call for applications that PCORI had done in, what was it, 2017, a decade ago. Can you imagine?

Manisha 08:46

No, it looks like a decade. You’re absolutely right. The study went through middle school and now high school and now preparing for college. So I would just like to add that really the study was designed not to answer the question, does palliative care work? We all do. It works. I think putting efforts into this question is just futile, probably. We already have substantial evidence on this point. The question we were trying to answer was very different. For patients with advanced liver disease, what is the best way to deliver it? That’s why we compared these two active competitors, you know, and what were the

Eric 09:22

two active comparators for? Because our listeners may have not read this study. What, what, what are the two active comparators?

Manisha 09:28

So the two active competitors was treatment A or model one is where palliative care was delivered by palliative care specialists who have decades of training, experience, board certification, and they are the ones who are delivering palliative care using evidence based guidelines. And treatment B or Model 2 is our hepatologists who underwent primary palliative care training for 12 weeks. We had an online program. We can go into details for that. But those people who are already taking care of these patients or patients with advanced liver disease, most of their care happens within the field of hepatology because that’s a complex population needing specialized care. What we equipped these hepatologists was not liver knowledge.

They already had. What we equipped them with some was some basic primary care, palliative, you know, primary palliative care skills on effective communication, seriousness, conversation, caregiver assessment, symptom management, decision making, shared decision making. Like all those beautiful 10 aspects of palliative care were integrated into their routine care to deliver these services.

Eric 10:35

How long was the training?

Manisha 10:38

So the training was about 12 weeks. The training was adapted from the field of medical oncology. So I myself took the course again a decade ago. Palliative care always focused on medical oncology offered through Stanford online program. Again, probably at that time Coursera was free. So, you know, like you’re just giving your time and effort and this is always interesting to learn. So I did the course and I’m like, can we convert this if scenario from medical oncology to liver? Because to treat your liver specific providers, you need something which is there, which is important to them, which they care about day in and out.

So we utilized some funding from our local foundation, Albert Einstein Society. Really thank you for their support for helping us tailor the entire program from A to Z. So the entire liver case scenario, which was informed by palliative care physicians, by hepatologists, There is a group of hepatologists who are much committed to integrate palliative care into their routine practice. So we identified those key members as a part of our executive committee. Dr. Volk, Dr. Navarro, Dr. Teddy. So all of them came together and we tailored the entire program along with our research advisory board members who were patients who lived with Liverpool, you know, cancer or other chronic illnesses. So this training program was offered online. 12 weeks weekly sessions with some zoom sessions.

Eric 12:00

How many hours?

Manisha 12:03

About say two to three hours.

Eric 12:07

Three hours.

Marie 12:07

I’ll jump in here. So there, there was like a pre course knowledge survey and then each of the modules you could spend like from one to three hours in that. And in each of the modules there were also some active synchronous case studies and discussion groups of the case studies that you know, we evaluated what the hepatologist thought about the case studies and the course in general. And there was really overwhelming positive feedback maybe because this was a tried and true course that had been done in other diseases.

And you know, Janofrio and Kavitha Ramchandran were leaders in doing the course and they were sort of helped us to specify the course or tailor the course to hepatology.

Chris 13:02

I would just add that it includes what you would expect. There’s modules on physical symptoms, psychological symptoms, spirituality, psychosocial need, communication, hospice, advanced directives, et cetera.

Alex 13:14

And is this. So I was emailing back and forth to Carl Bischoff, who’s a researcher and clinician, palliative care doc here at ucsf and we were saying, you know, is this realistic like in the real world, outside of a study that hepatologists would do 12 three hour sessions? Like they’re pretty busy people, I mean like incredibly impressed they did it for this study. But like in the real world, I don’t know. Did that come up in the qualitative interviews? Were there people who declined to do it because there’s absolutely no way they had time to do 12, three hour training sessions.

Manisha 13:53

We had no declines, honestly. So I, I mean we’ll go back again a decade ago when we recruited these sites. So these sites and these investigators were, you know, not picked, but they were recruited from a group of healthcare delivery special interest group which we have in a month within our national organization, the aasmd. Where people come together, you know, they engage and that’s the place where we were able to identify some people who were really interested to be trained. And like this really seems interesting. And since I think the biggest selling point was this was all liver disease specimens. So whatever they are talking about really matters to them in a lot. They want to help improve the quality of life of their patients.

They want their patients to be satisfied. They already know. So we didn’t talk too much on, as I said, we didn’t talk too much about the liver. We talked about how to do it, how to integrate these things into their you know, routine practice. And to your point, there was a mix. You know, as I was telling Chris in the morning too. It’s like we had a wide variety of people, some who said, I already do it. So this is a part of our practice. I talk about symptoms, I talk about quality of life.

And some are like, I don’t really do it. So I would love to know. So there is a wide variety of people and I think the training helped us level them to one standard for a clinical trial. For a trial you need to have some sort of an intervention. Fidelity maintenance. And this training along with a checklist which Marie really helped design based on her feedback, like what are the key elements they will assess? So those things really helped bring everybody to one common point.

Eric 15:27

Go ahead, Chris.

Chris 15:28

I want to jump in with two points. One is just acknowledging that I think Manisha in the beginning, as part of preparation for the study, did incredible coalition building in a field that hasn’t had much cross talk with palliative care in the past. Number one. And then number two, this is jumping into the future or sort of spinoff ideas a little bit. But to Alex’s question, in the further iterations of these trainings that we’ve worked on, we adapted it for liver and GI fellow trainees and then we’ve also adapted it for materials for the AASLD online, like online content.

And both of those were obviously updated but also condensed. So the fellows course was condensed in terms of the length of the synchronous sessions and also the number of weeks. Like, no, I’m forgetting if it was six or eight. But so yes, it is a consideration.

Manisha 16:24

That’s been the focus. That’s been the focus. We are trying to condense it because now we also have learned, you know, what, what is the missing part? What is the missing part in the current training program that should be filled in with these primary palliative care skills. Now AASLD has given us the guidance document which kind of summarizes the entire palliative care aspects in 34 pages. If someone is really interested, the homework would be to just read through them and understand it. But I think the effective communication practice is where our training program was well suited and people really appreciated the opportunity

Chris 16:56

to undergo this training just for the, the audience. The AASLD commissioned a, a clinical.

Eric 17:04

What is aasld, by the way?

Chris 17:06

Sorry, American association for the Study of Liver Diseases. It’s an international organization, but it’s the one that’s based in the US it’s our. It’s our it’s their AHPM, HPNA. And so they commissioned this document in 2022 to have a comprehensive palliative care sort of statement and included symptom management for the management of decompensated cirrhosis.

Eric 17:31

And real quick, the folks of that. So you compare this group, hepatologists that got this 12 week training versus palliative

Alex 17:39

care specialists who got no training in liver disease.

Eric 17:42

No training in liver disease, which is a key point. And what did that palliative care specialist look like? Were they physicians, nurse practitioners, nurses, social workers, pharmas? Like who was this palliative care specialist?

Marie 17:56

So the palliative care specialists. Oh, sorry, Go ahead, Marie. The palliative care specialists were both nurses, advanced practice nurses or physicians were the primary provider of the palliative care assessment and follow up sessions which were a standardized thing, but it wouldn’t be anything unusual that a palliative care person wouldn’t normally do in, you know, an initial assessment and three follow up visits that were done monthly.

Eric 18:25

Okay. Any other team members involved besides the advanced practice nurse or the physician for the initial assessment?

Marie 18:33

No, but then they were referred amongst the team members, you know, as need be.

Manisha 18:38

As need be, yeah. So I think that’s the distinct point of this study is we did not rely on a, the team based model to begin with. We’re like, you can build your team if you have to. That depends on the patients. It’s so individualized. And if the patient needs pt, you can refer them. But we did not require a team.

Eric 18:55

Yeah, so, and so you’re comparing these two groups, palliative care specialists, MDs, nurse practitioners, to these trained hepatologists in palliative care over this 12 week. It was a cluster randomized control trial. Right. Because now you’ve trained these hepatologists. You, you, you can’t now randomize the patients. But who are the patients that you were looking at? What was the inclusion for the patients?

Manisha 19:19

So the patients. So I’ll just kind of refer to the patients and the cluster design. So by design it was randomization of the site. This whole center, it gets randomized to the PC or the palliative care specialist. So they’ll see all the patients, all their follow up because their hepatologists did not undergo any training. Just to be clear, the hepatologists and the palliative care site did not undergo any training, only the hepatologists at the hepatology kind of randomized arm. And this training happened post randomization, before random, before randomization, all the Centers had a clear perspective that they can be randomized to this arm or to this arm.

They should be prepared to do whatever. And they were committed, fully committed. Now we get randomized to this. But again, randomization happened which was thing which really sparkled ideas as to where each center would fall. But the patients enrolled were decompensated cirrhosis patients who had any of a single episode of decompensation or more in the past six months. So decompensation means they had a deteriorating effect of liver disease related to ascites or development of decompensation, bleed, encephalopathy and those things. Or they were liver cancer patients except stage D. So we have, we did not include very, very advanced patients because the primary endpoint was three months. So we wanted to make sure we have enough patients who do not die or other things to make sure there is enough follow up.

Marie 20:50

I think importantly the transplantation maybe. Chris or Manisha, you want to comment on the criteria that related to transplantation?

Manisha 21:01

So it was like we did not want to include patients who are expected to be transplanted within the next three months because transplant is, you know, a life changing whole journey and that needs a separate whole conversation.

Chris 21:14

There was also an exclusion, Manisha, correct me if I’m wrong of if the hepatologist felt that the person had less than six months prognosis, which I think is an important point because if you look at the composition of the, of the study population, it’s a relatively functional, higher functional status with a relatively low, not that low, but mortality rate.

Eric 21:37

And that’s the hepatologist in either group. The, the ones who got the control mayor, I guess palliative care specialists versus

Chris 21:44

whatever, whoever their epidologist is who was under. Whoever was taking you caring for them.

Manisha 21:50

Yeah, yeah.

Eric 21:51

You also excluded hospice patients or patients who are enrolled in hospice.

Manisha 21:57

So finally we did not respecify any criteria. I know the patient was going to hospice. Probably they were not included anyways because the key exclusion was also people who received palliative care within the past three months.

Chris 22:11

Okay.

Manisha 22:12

Any patient who do have a washout period for three months was considered. But in the actual analysis we excluded people who were either transferred to hospice or received a transplant within three months of intervention.

Alex 22:26

I wonder if in the quest to obtain this like clean sample that hadn’t been contaminated by palliative care to the extent that palliative care can be a

Marie 22:35

contaminant or a transplant, they had been contaminated by a transplant or contaminated by hospice, which is palliative Care too.

Alex 22:44

Yes. Right, right. Or had a limited prognosis. I’m wondering if our listeners are thinking, gosh, like, you know, when our palliative care team sees patients with liver disease, that’s the majority of patients they see, you know, patients who are of limited life expectancy who, like, might get on the transplant, you know, might be getting a transplant, but might not be because they’re, you know, to get a transplant, you’ve got to be sick enough to get a transplant.

That bumps you up the list. So you’re pretty sick at that time, you know, so maybe they co. Manage those patients as well. Maybe they see patients who are enrolled in hospice. I think that’s less likely. But do you worry that you’ve could have taken the major group that sort of benefits from and in practice is seen by palliative care out of this study population?

Marie 23:32

I think that that was the goal, actually, is all those people that you just described, Alex, are very near end of life. And we are talking about what one would call maybe your garden variety advanced liver disease patient who’s not currently heading immediately for a transplant or not in hospice. Right. And so those two groups are ones that might be likely to get more involved in palliative care. So this was like everybody else. So I’d actually describe it like the opposite way. This was like the majority of ALD patients and we kind of cut off the edges of people who were sort of near death or headed down a curative route.

Alex 24:15

That’s very.

Chris 24:17

I mean, how often do you see somebody in outpatient palliative care routinely who has, like, who has advanced cirrhosis, but their meld is low, Very, very rare, at least for me. You mentioned the issue of contamination. I just have a sort of funny. Not funny, but anecdote. You know, I got involved in this study at one of our affiliates, which Crystal Hunt’s the hepatologist there. But she invited me knowing that I was very interested in palliative care for liver disease. And we were going to be a site for the study.

And I helped with the, you know, the grant and the hiring and the study startup at Eyesight. And then they got randomized to the hepatologist arm. And I was like, all right, well, it was nice knowing you guys, because I was like, I can’t come to your. Like, I can’t come and contaminate this. But I guess a lesson for early career me, you know, showing up is so critical for this work and for success, I think, in what we do. And so I kind of just kept showing up at the larger meetings for the steering committee. And you know, you do that enough and not be annoying and be helpful and end up on committees.

Manisha 25:24

And you know, Chris, you were very helpful. No, very helpful. And actually we became. Became very good friends. So Chris was a part of our team.

Eric 25:34

I got another question. I got two questions about the methods and we’ll go into the results. First is you did a modified intention treat and then that modified you excluded. We talked about transplant patients, but also hospice patients, people who transition to hospice before three month assessment. Why? Because I feel like an important part of palliative care consults is also knowing when to refer to hospice and talking about hospice. I mean, that’s something that’s important that we do. Why exclude that from. From the analysis or from the modified intention to treat?

Manisha 26:08

So I’ll take the response. I think the sense that was mainly the effect of the hepatologist intervention. You know, for the first three months. That’s the primary endpoint. And you cannot allow contamination by when you depend patient is in hospice. The entire care is, you know, all hospice, drug hospice, palliative care providers. So it was very difficult for the hepatologist to even intervene into the care planning at all. So I.

Eric 26:32

Isn’t that part of palliative care training? Like knowing when to refer somebody to hospice?

Alex 26:37

It’s like a post hoc thing that couldn’t be known in advance.

Manisha 26:43

Yeah.

Eric 26:43

And it’s one of our interventions that we do. And isn’t an important outcome to like why remove those patients? Because it is part of our armentarium.

Marie 26:54

I think it was a very small number. It was a very small number.

Eric 26:58

It didn’t actually influence anything.

Manisha 27:01

Yeah, it’s only 17 patients, 10 in the consultative PCR and seven in the hepatologist around Hoover transferred to houses within the house.

Eric 27:09

So there’s no big difference there.

Manisha 27:11

No big difference.

Eric 27:12

All right, I’m gonna take away that away then. My second is, is that you, you had some ways a statistical squeeze here. You had Covid, which I understand hit there again 10 year study. And you had to decrease the sample size. But then you also switched to an interesting framework where you first assess for superiority. Was hepatology one better than the palliative care specialist one. And then if it didn’t meet superiority outcomes, you switched to non inferiority framework which happened not was not planned at the start, but somewhere during the middle of the study you added the non inferiority which like if this was a drug and I saw pharma do This I would be like ew, that’s a big no no.

Because if you add something like non inferiority now you’re at non inferior margins are super susceptible to bias. Like I’m going to choose a non inferiority margin that I think will work. And it also significantly changes how you think about sample size calculations. So tell me how that happened and why you did that.

Manisha 28:19

Yeah. So maybe I’ll tell you a little story. PCORI built a PCORI Learning Network. PCORI Palliative Care, PCL and Palliative Care Learning Network which comprised of eight large science studies which PICORI invested almost 80 million into this funding announcement including Jennifer Tamil, including Corita from New York, there’s eight to nine funded studies. So as a part of the Palliative Care Learning Network they put together a team of biostatisticians to discuss about what kind of analysis should go in me being very naive. We attended and we worked with Duke Dr. Andrei Kusinski as our key statistician lead. He, you know, he is a key part of this kind of decision making as the statistical expert. So we attend the meeting and everybody was like what if the superiority fails?

Again this is a meeting which is for learning, for exploring what are the best way or put your foot forward. Particularly during COVID these meetings happened virtually and during those times there was a brilliant idea from some of the like minded statisticians that there is a way you can inbuilt a non inferiority to again not to demonstrate that one is non inferior but to actually keep your studies integrity intact. So we thought here we are. I mean I would recognize this is tough. Having a hepatologist deliver palliative care is tough. It’s tough, it’s a lot of time issues which I’m sure Marie will talk from our qualitative interviews.

They liked it but there was a lot of other competing priorities and there were things which were not going right at some places. So we added this non inferiority during the triumph design but without any outcomes data. None of the investigators, not even the statistician himself. So since we worked with Duke, I think they had a very rigorous system of blinded versus unblinded statisticians. Very rigorous. I mean they really follow the protocols. I had no access to any outcomes data, did Andre.

So we really designed this non inferiority hypothesis during the design, during the trial conduct prior to any sort of unblinding as a framework to assess whether hepatologists delivered palliative care could achieve outcomes which were comparable to specialty palliative care and this approach was really motivated by feasibility and implementation considerations. And also I’ll just like to highlight that non inferiority still had a non inferiority margin of at least four points. And those four points were based on Dr. Tamel’s trial on palliative care and non on the non cancer patients.

Chris 30:56

Says it’s half of the mini minimal clinical, clinically important difference for the quality of life instrument.

Manisha 31:03

Yeah, and none of the interim data analysis informed this. This was merely, you know, an open ended discussion which brought back home some ideas. It’s like what if everybody is fearful if this doesn’t go then having an inbuilt mechanism. I’m very thankful to all these statistical methods to make sure we have this concept which is new.

Eric 31:23

So what did you actually find?

Manisha 31:26

There was almost a 7 point improvement in the palliative care arm in quality of life which is our primary outcome from baseline to three months. An eighth point improvement. I mean adjusted change in the hepatologist arm from baseline to three months. Superiority wise the P was non significant. However, based on our predetermined non inferiority margin the statistical significance was strong for the non inferiority hypothesis. Which still means the hepatologists did a little bit better and they’re comparable to the palliative care specialists. But again I’ll just like to highlight one thing here.

We are not comparing providers, we are really comparing the two models. We are really comparing the implementation aspects of both these models. And, and both are equally good. That’s the real outcome.

Alex 32:17

And you just said the hepatologist did a little bit better. Could you finish that sentence then did

Manisha 32:24

a little bit better than the palliative care, than the palliative care model.

Alex 32:28

Then the palliative care specialist. But that, that was not a. And that was. Was there a statistically, statistically a difference between them?

Manisha 32:36

No. The non inferiority P was 0.01 and the adjusted mean difference is about 1.

Alex 32:45

Does that mean that there was a statistically significant difference in the.

Marie 32:51

Or non inferiority. So for equivalence. Yeah, to demonstrate that there was equivalence between the models. So the first test which was the superiority of hepatologists was not statistically significant. And so then they went and looked at were the inferiority hypothesis and that was statistically significant. Kind of a double negative. So non inferiority. It shows that they were not inferior to each other. Does that make sense?

Eric 33:28

They were equivalent which means that they fell within side that non inferiority margin, whatever margin that you could put.

Alex 33:35

That’s what I take away from it that they were equivalent, not that the hepatologists were doing better than the palliative care specialists.

Eric 33:45

They had a numerically.

Alex 33:47

Is that fair, Manisha, to change that sentence? Yeah.

Manisha 33:49

Sorry.

Alex 33:49

Okay.

Manisha 33:50

Thank you. Correct. Yeah.

Eric 33:51

And they had a numerically larger improvement, but they actually started a different. The hepatologist group, I think, had a worse quality of life score at the start. Is that right?

Manisha 34:02

Correct. Correct. That is true. There was a slightly. I mean, it was controlled for in the final analysis. It was adjusted. Yeah, but the hepatologist group had a worse quality of life to begin with.

Eric 34:12

Yeah. W. Which is also, I guess, one other critique of this article which is like, if you have to adjust for something in a randomized controlled trial, like, how good was the randomization? I didn’t notice that the number of patients in the hepatology group was significantly less. Not. I wouldn’t say significantly was less than the number of patients in the palliative care specialist group. Any idea why that was the case?

Manisha 34:40

Yeah, yeah. You know, I. I think again, it would go back to those five years we monitored enrollment every single month. There are two kind of things which are not written in the published article. One is, of course, there is randomization, but then there is. Every site has their own research operations. We found there were at least four or five strong research operations sites which were in the consultative palliative care arm. They were enrolling every single month. But here is the hepatologist group struggling to recruit coordinator or there is more staff turnover. We are looking for more staff. There is staff training. The study coordinators actually were the key component of this.

Eric 35:21

Do you think that could have influenced results at all as up for anybody?

Manisha 35:29

I think that’s like. I don’t think the outcomes would have been influenced by that. The number of patients are still comparable. There is no statistically significant difference at baseline among these two. So I think the results would still be the same. It is just the implementation methods which, you know, every site had to do their own. I cannot create a room for a hepatologist site because they don’t have enough room for us for doing this intervention. We had a site where this was a problem. Yeah.

Eric 35:57

Okay, Chris, I’m going to turn to you. Are you doing anything different with the results of this study?

Chris 36:04

Oh, like in terms of changing practice?

Eric 36:06

Yeah. Should we do anything different with the results of the study?

Chris 36:10

Well, okay, so what? Before we knew what they were, I would always sort of think, I wonder what it’s going to be. And I worried that if it came out one way that hepatologists were, you know, superior, that people would say, well then why on earth would we embed palliative care in our practice or refer people to outpatient or whatever? If the opposite were true, I would worry that people would say, well, why are we bothering spending our time doing these modules and owning some of this care?

Eric 36:45

Just give it to palliative care.

Chris 36:47

Yeah, we can just refer out, which we all know, obviously we are for a hundred reasons, isn’t always easy. And then so in some ways the, the fact that we have a non priority finding is, is interesting because it, I mean, a question begets a question, right? So now it’s like, well, what are the implementation questions? What are the factors in one health system versus another that might promote success of one model’s implementation over another based on preferences, structural, systemic, all the things. So for me that’s a huge takeaway.

Marie 37:26

I think another implementation of what you were talking about, Chris, challenge came out in the qualitative data. When we asked hepatologists what was it like doing this type of care? What did you do differently? How was it like talking to, I mean, and we asked palliative care people, of course, the same question. We also asked hepatologists what they thought of the training. And they universally loved the training. Some of them loved role play, some of them hated it, you know, but overall there was the hepatologists really loved the training.

And we’ve got actually three papers where talks about what they thought about the training. But you know, getting back to the implications of it, they pretty much said the same things with a light, slight nuance. So the hepatologists were like, the amount of time that this takes is really a lot more than my usual, the way I would usually do care. But it was really worth it. And the reason it was really worth it is because it improved their relationships, their communication. A huge finding was they talked about, they had never talked to caregivers before.

I mean, I say never, kind of in, you know, hyperbole, but they hadn’t talked to caregivers before. Now because of the study, they were forced to talk to caregivers and they’re like, wow. And I mean, one of them actually said, I really feel like I’ve neglected caregivers to this point because I just never even thought of talking. But it’s so valuable. I mean, the caregiver piece was overwhelmingly described in all the hepatology. Clinicians. Like this is so important. Like they just discovered it. Interestingly, the palliative care people like, they never talked about caregivers because routinely we’re seeing caregivers.

Right. It’s part of the unit of care. Right. And so it’s very interesting that real dichotomy between hepatologists discovered caregivers and palliative care didn’t think anything of the caregiver piece of it because they do it all the time anyway. So that the timing piece and the caregiver piece were two things that really came out in terms of practical implementation going forward. The hepatologists, they used to book their study patients when there was no other patient following them. So they had plenty of time at the end of the day or on a non clinic day. Like they’d see their research patients on a non clinic day.

So they weren’t wedged in the time. So that was a huge issue. And the palliative care clinicians reflected on time and said they think it’s great, but I don’t know where they’re going to find the time to do this, you know, sort of going forward outside of the study. So those are two really big, you know, reflections.

Eric 40:10

Let me ask you about that then. So you have a busy hepatologist who is, who makes a lot more than a palliative care doctor. Palliative care doctor can generally book a little bit longer visits. The, you know, the hepatologist has like 13 million other things to do. Like if you were to, to design a system knowing the results of these studies, like it one’s, let’s imagine we all agree one’s not better than the other. They’re equivalent, at least within this non inferiority margin. Why not just choose the cheaper one and have the hepatologist do all the hepatology stuff that they gotta do.

Chris 40:53

Well, is it cheaper? Because. Right. We need space. Yeah, space. It’s an opportunity. If you could put a proceduralist in the room that I’m using, you might make more.

Eric 41:05

But I just also heard the hepatologists had to schedule these patients on a day where they had more time in like real life. Like what would this look like outside of the study is, you know, the system is perfectly designed for the results it gets. And we see this kind of over and over is like I was the worst palliative care doctor when I was attending on the wards. I was doing both. Like one week I beat palliative care, one week I attend on the wards. The second I hit the wards, my palliative care doctor like disappeared. And that’s because like you are focused on so many other things.

Manisha 41:42

I think what we also learned, I mean, you know, through personal conversations and through a quantitative input was also experience over time. You know, we all go through kindergarten and then through high school. I know I talk about school a lot. That’s the place I love. But you know, when you were doing these conversations, people were saying they were taking longer during year one. However, over time they become quicker at it. I could do this much more quicker. I know how to build it, code it, use the G22 modifier.

When we had individual conversations with some of those hepatologists post study to see how it is now part of their practice. Some people are still doing it and I’m really hoping we will do a follow up survey and qualitative interviews with these hepatologists. After one year of PAM liver, how much did you actually take into your routine practice? So we are still, I think again if you really enjoy, if you really value your patients quality of life and you want to make sure it is getting better, people are making time and they are getting good at it. Once they have learned the skills and practiced over some time, the skill set becomes much more advanced.

Eric 42:48

Yeah.

Chris 42:49

I would also add, I perhaps most importantly that we also see and this is not published yet, but under review. The patients valued the time too. The patient and the family. Sorry. And the family. Caregivers in both arms. There’s data from the interviews that where people say I really appreciated the extra time. I felt listened to, I felt like I had access to the, to the team, et cetera.

Marie 43:15

There was always someone there whenever I needed somebody. Which was a very different experience than they had had previously. They were like my friend. They would say like they would answer whenever I called. It was, it was really amazing to hear the patient and caregiver results. And you know, we’re really sort of putting a teaser out there for when the paper, full paper comes out. But you know, that was really a major thing. And so I think there was this really synergistic thing where the clinicians felt more satisfied and the patients definitely felt more satisfied and together, you know, they were happy.

Eric 43:56

Yeah.

Manisha 43:57

And since satisfaction is the goal, you know, I’ll just add one more thing. Since satisfaction is the goal for many healthcare systems to achieve, this is something which they can adapt. Now this intervention is going to help you satisfy your patients, improve your satisfaction scores and test gain new scores. So why not adapt it? I think these are again plannings are steps for making it forward. And we don’t want this intervention to wait for 17 years to be implemented into routine practice. Now we want to cover up with some implementation gaps, I think. Really excited to see where.

Eric 44:30

So what would your, if you had a magic wand. Last question for all three of you. What would that implementation look like? Like what would you use that magic wand on knowing the results of this study. Manisha, I’ll go to you first.

Manisha 44:41

Okay. What I would think is, you know, if I had access to 10 healthcare systems CEOs, they’re just sitting next to me and very friendly and ready to talk.

Eric 44:51

It’s a magic wand. You can do anything right now.

Manisha 44:53

So they’re like, okay, here Mr. CEO, there you have two choices. Model one, the consultant and palliative care arm. We are going to give you the tools, we’re going to give you the checklist and list of criteria so you can focus on early palliative care for these earlier stage patients so they have a better quality of life over time. And here is, you know, we can train your hepatologist and gastroenterologist probably in your network and save you your palliative care resources for your cancerous and serious illness, seriously ill patients who really need that specialist service. Can you train your providers here and use these implementation strategies to adapt the models?

Eric 45:33

Chris?

Chris 45:34

I would take a small palliative care team that’s multi professional to function as champions and also clinicians to provide, you know, longitudinal interaction, liaising between the departments, maintaining ongoing education of the, of the different of both groups and then figure out in that setting what are the facilitators of referral between the trained hepatologists and the specialist.

Eric 46:04

So you’re doing a little bit of

Chris 46:05

both, a little bit of both. And you know, they gotta figure out like what, what is the slot length that you’re gonna do, what is a new appointment, what’s a follow up, et cetera.

Eric 46:14

So Marie, last one. Magic wand.

Marie 46:18

Magic wand. We just take the, the time money continuum out of the picture and just let people do a really good job of what it is that they enjoy doing.

Eric 46:30

Wonderful. How about Alex enjoys singing. Maybe he can do a little bit more abba. What’s the song titled again? Manisha.

Manisha 46:38

It was the slipping through my fingers.

Eric 46:40

Great. Alex,

Alex 46:46

(singing)

Eric 48:10

Chris, Manisha, Marie, thank you for joining us on this GeriPal podcast.

Manisha 48:14

Thanks, Alex. Yeah, I would just like to thank and express gratitude to the entire Paliative team. You know, it was not a single person’s job. It was a huge team of collaborators. And the leadership of Dr. Victor Navarro, who has been my mentor for more than a decade, couldn’t have done it without him. And above all, the Piccore program officers, Dr. Neera Jamara and his team. They were so supportive of each and every step we took.

It was not an easy journey through the six years of this trial to meet the enrollment goals and make sure everything is working. And above all, our research advisory board, really, I think every element of this trial is patient centered and patient focused and really want to thank the entire team.

Eric 48:59

Well, thank you for that. And I’d also like to say thank you to our listeners for your continued support.

This episode is not CME eligible.

For more info on the CME credit, go to https://geripal.org/cme/