Wednesday, July 26, 2017

Should Clinicians Be More (or Less) Politically Active?

by Christian Sinclair

Politics and healthcare are occupying much of the news cycle this summer with all of the discussions around the possible repeal of the Affordable Care Act (AKA Obamacare). On one hand it can viewed as must-see reality TV with all of the drama and back and forth arguments with passionate opposition. Late-night TV hosts help turn the drama into satire and give everyone a good laugh and some entertainment. Yet it is important to see that this will greatly impact the care of the patients we see every day.

To be honest, it was not until a few years ago that I started to see the power of getting more politically involved as a physician. . I thought that dutifully voting was doing my part as a citizen. Nowhere in my education was it ever modeled for me that I should use my training and experience as a doctor to help influence public policy. Talking to legislators? I don’t have enough time. I’m a busy doctor. Emailing legislators? They probably hear from other people. Reading up on the pros and cons of new legislation and how it may impact me as physician? That is why I pay dues to professional societies and their lobbyists.

A few years ago, I got the chance to go to a Hill Day with the American Academy of Hospice and Palliative Medicine. The morning started off great with legislators and their staffers coming to tell us about the importance of the public voice in a thriving democracy. It was just like being back in High School in American History class with Mr. Horvath! We were given our assignments for the afternoon to walk around Capitol Hill and meet our Representatives and Senators and tell them why we supported the Palliative Care and Hospice Education and Training Act (PCHETA).

Despite speaking on the merits of hospice and palliative care to thousands of people over the years, this setup for a small meeting with political leaders was intimidating. As legislators, they seemed distant and removed from my everyday life, but yet they were critically important to the function of government. Reflecting back on the passage of the Medicare Hospice Benefit, I tried to muster up the courage of those empowered volunteers of the early 1980’s. Many of us would not have careers if they had not knocked on Senators doors and told the story of people at the end of life.

Sitting in Senator Roberts office, I waited with my advocacy team. We struck up a conversation with the other people waiting to visit the Senator. They were from the United Motorcoach Association and mentioned in the course of our small talk they had been here before. I was bewildered. What important policy issues could the United Motorcoach Association have to talk about? Were they more important than the care of hospice and palliative care patients? But then it hit me. They have every right to be here, to advocate for their interests, to represent their story. And if they were here telling their story and I didn’t show up today, Senator Roberts would have no knowledge of what I care deeply about. If we don’t show up and tell our story, then no one is going to care enough to reach out to us to find out more information and therefore other policy priorities will be advanced long before ours.

So knowing that physicians vote less often than the general population (and even less often than lawyers), how politically involved should we get on behalf of our profession and more importantly on behalf of our patients? This will be the topic of the July 2017 #hpm Tweetchat too so if you want to join the conversation, get on Twitter at 9p ET on July 26th. You can also add your comments below.

Christian Sinclair (@ctsinclair) is a palliative care doctor at the University of Kansas Health System, and immediate past president of the American Academy of Hospice and Palliative Medicine. He writes for Pallimed when he doesn't have other deadlines impending.

Wednesday, July 26, 2017 by Christian Sinclair ·

Monday, July 17, 2017

Choice: The Hidden Curriculum in Palliative Care

By Paul Carr

Thank you to Dr. Naheed Dosani and the excellent team at William Osler Health Centre for inspiring this post.

What three words describe the essence of palliative care for you? When I asked my friends, family, and colleagues, the most common answers are: pain management, personal and spiritual support, and end of life planning. Those are all key components. But what quickly became apparent to me during my palliative care elective is that excellent palliative care providers embrace the role of enabling patients and families to make well-informed choices.

I have taken a long and untraditional route to arrive in the field of medicine. I’m over 40 and spent 16 years teaching elementary school before starting the MD program. As a teacher, I heard and read a great deal about the Hidden Curriculum: things that are not taught explicitly but are ingrained institutionally and learned through experience. Examples include behavioural protocols such as “Do not challenge your preceptors” even though you are told to question authority, and subtle reinforcement of gender roles in institutions that outwardly advocate for individuality. And I argue that patient choice is part of the Hidden Curriculum in palliative care.

Choice and Palliative Care

This is the World Health Organization’s (WHO) website's definition of palliative care:

It is an approach that improves the quality of life of patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.

Following this definition is a series of bullet point items which explain what palliative care is or does, but without any reference to patient values, wishes, or choice. This is the essential mistake we all make in medicine. We guess at what will make our patients happiest, and then recommend the treatment most likely to attain that outcome. The danger is that if we don’t know what our patients want, we may end up providing them with longevity when they are seeking contentment and the company of family (or vice versa).

Patient Values and Choice In Medicine

An episode of the excellent Balado Critique podcast from Universitié de Sherbrooke reviewed the EXCEL and NOBLE trials, which compare bypass surgery to stents for treatment of heart disease. The experimental endpoints included all-cause mortality, repeat revascularization, stroke, and MI, which are all likely meaningful to some extent for a large majority of patients. But I was struck by the fact that these measurements may miss the point for many patients.They are inadequate for formulating a care plan, because they do not explore the goals, values, and wishes of each patient.

We love ‘hard numbers’. Government health agencies, private insurance companies and hospital executive boards love ‘em. They’re super for projecting on smart boards and backdrops during meetings and fundraisers. But what about the older patient who feels she has completed what she considers a good, satisfying life? What are meaningful primary outcomes for her? I searched the original text of the EXCEL trial for the words ‘pain,’ ‘satisfaction [with treatment or quality of life]’ and ‘happiness’ and I received a grand total of zero hits.

There have been attempts to quantify patient experience in research. As early as the late 1960’s, the concepts of Quality Adjusted Life Years (QALY) and Disability-Adjusted Life Years (DALY) experienced varying levels of acceptance (often by economists and accountants). More recently, research in dermatology has used specific scales such as Skindex and SCI which are based on experiential subjective self-reporting from patients.

The problem is that trying to quantify subjective experience is like trying to create a metric for favourite colour, or flavour of ice cream. The European Consortium in Healthcare Outcomes and Cost-Benefit Research performed an extensive study and concluded that “the hypotheses that found the QALY approach do not correspond to behaviour patterns observed in real populations.” This result was entirely foreseeable because we can no more predict what patients want than we can guess that their favorite colour is blue or their favorite ice cream flavor is rocky-road.

Enabling Patients To Choose

Consent law focuses on the ability to understand illness and treatment options, as well as the consequences of treatment selection or refusal. It sounds strange, but patients often are not aware of their own goals and values because they have not specifically paused to think about them or take inventory. I remember participating in a conversation with a gravely ill patient who asked initially for all available life prolonging options. My preceptor did not challenge the patient or recommend a course of treatment. She simply inquired, “Help me understand your choice. What is most important to you in your life right now, and what would your ideal end of life look like?” The patient talked about grandkids, spending time or even dying at home, and not wanting to be laid up in bed attached to machines. I don’t think my preceptor said more than 10 words in the whole conversation, but the patient had come up with some outstanding goals of care. Over the next couple days, the patient and the entire palliative team came up with a plan of care to meet those goals to the greatest extent possible.

Patient choice must emerge from the the Hidden Curriculum and take its rightful place as the basic starting point of all good medicine.

On the last day of my palliative medicine rotation, a young woman came in with a cake for the nursing staff on the inpatient ward. She explained that one year ago, her mother had died on the ward. At that time, the young woman was too sad but now she wanted to let the staff know they had provided her mother great care. She didn’t mention a single common research metric, but she smiled with gratitude and joy in remembering her mother.

References:

Balado Critique: Épisode 5 Études EXCEL et NOBLE. https://wwwusherbrooke.ca/baladocritique/archives/episode-5-etudes-excel-et-noble/
ECHOUTCOME Report Summary http://cordis.europa.eu/result/rcn/57938_en.html

Mäkikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet 2016; Dec 3; 388 (10061):2743-2752. PubMed PMID : 27810312

Franco Sassi; Calculating QALYs, comparing QALY and DALY calculations. Health Policy Plan 2006; 21 (5): 402-408. doi: 10.1093/heapol/czl018

Stone GW, Sabik JF, Serruys PW, Simonton CA, Généreux P, Puskas J, et al. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016 Dec 8; 375 (23):2223-2235. PubMed PMID : 27797291

WHO definition of palliative care:
http://www.who.int/cancer/palliative/definition/en/


Paul Carr, B. Mus. (McGill University, 1999) is a student in the MD program at McMaster University. He previously spent 16 years as a performing musician and junior/intermediate school music teacher. Paul sees interpersonal skill development as being a key to making healthcare more satisfying for patients and practitioners alike. His Twitter handle is @PaulCarrMD2018

Ice Cream Photo by Markus Spiske on Unsplash

Monday, July 17, 2017 by Pallimed Editor ·

Friday, July 14, 2017

Palliative Care & CHF: PAL-HF trial



The main results of PAL-HF - a randomized, controlled trial of specialty palliative care team involvement in advanced heart failure patients -  have just been published in the Journal of the American College of Cardiology (DOI: 10.1016/j.jacc.2017.05.030. Clinicaltrials.gov registration here). 

This is an important, well-done study, with encouraging results - specialty PC improved the quality of life of patients with HF. I'll discuss the results in more details in this post.

The study was done by a multi-disciplinary team of palliative & cardiology investigators at Duke. This week's publication looks at QOL results which were the main, pre-specified outcomes. Of note, in the clinicaltrials.gov registration for the study, they do pre-specify healthcare resource utilization outcomes as one of their secondary outcomes, but this paper doesn't  present those data - presumably those will take them longer to collect and will be forthcoming. 

PAL-HF enrolled 150 hospitalized patients with HF at high risk of mortality or rehospitalization, and randomized the patients to receiving specialty palliative care vs usual care. They identified patients using the ESCAPE risk model, which I hadn't heard of - key reference is here. The inclusion criteria involved the patients having an ESCAPE model predicted 6 month of mortality - notably in this study the actual 6 month mortality was 30%.

Intervention-arm patients received a palliative care visit, I think by a palliative NP - the methods section is a little cagey about who exactly saw the patient apart from a palliative NP, if anyone. The NP did a comprehensive palliative evaluation (physical, psychoemotional, spiritual evaluation), had a goals of care discussion, did advance care planning, and presumably made recs about what to do. The patients were followed for 6 months, which is the length of the data collected for this study. They methods say PC remained involved in the patients' care, although the exact nature of that involvement is opaque to me - eg it's not clear the patients actually saw PC in clinic or anything, and the role of PC may have been advisory to the cardiology team. The full methods of the trial were published in a different paper but even reading that it's not entirely clear to me who from the palliative team saw the patient in addition to the NP, nor the real nature of the 6 month planned follow-up. 
The primary outcomes were QOL on the Kansas City Cardiomyopathy Questionnaire and the FACIT-Pal QOL scales st 6 months. I need to say: 6 months, whoa. This is rare to see a study of this kind look at outcomes over such a long period, and it's one of the reasons I think PAL-HF will set a new standard in these sort of complex palliative-intervention trials. In the methods they note that a 5 point improvement in the KCCC and a 10 point improvement in the FACIT-Pal are believed to be clinically relevant outcomes. Their power estimate showed they needed 200 patients to show such a difference - they ended up enrolling only a 150 (but still showed a difference). It's not totally clear to me why they capped enrollment at 150 – they mention survival was better than anticipated. Nonetheless they met their primary outcome with less than the estimated number of patients (which is an argument for the robustness of their findings). Key here is that unlike a lot of  lower quality research they designed their outcomes to explicitly be patient-relevant, and powered their study as such. 

Patients had a mean age of about 70 years, ~50% were women, and ~40% Black. 

The outcomes at 6 months were good: improvement of 9-10 on the KCCC and 11 on the FACIT-Pal in the intervention group compared to the usual care group. These exceeded the thresholds for what is considered clinically relevant. Some secondary outcomes were improved too: depression and anxiety symptoms, and spiritual well-being (as measured using FACIT). 

As above, I am assuming the resource utilization outcomes are forthcoming. They do mention that survival and rehospitalization rates were similar between the groups (30% for each outcome at 6 months). 

My summary thoughts:

This is a well-designed and executed study - the sort of thing I read and say Gosh we need a lot more of these. Eg, fewer retrospective chart reviews and case control studies, more well-thought out, well-designed, prospective studies testing if and how palliative care improves our patients' lives. Besides wishing the methods write-up was a little clearer about the exact nature of the palliative intervention, I am few complaints about the paper. 

The limits of the study are intrinsic to its methods - and I want to talk about one of the major challenges we face in our research base, which is the challenge of generalization. Unlike a drug trial, team-based palliative care interventions are inherently complex, and presumably very sensitive to very local factors. Eg, what the good folks at the Duke palliative care program do may be somewhat different than what my teams do, and any other team in the country. It's well documented that while palliative care has become ubiquitous in larger American hospitals, that does not mean every program is populated by well-trained, competent, interprofessional teams. In fact, we know that many are not. What this means is that we know what the Duke team did really did improve these patients' quality of life. Generalizing, exporting, what they did to other programs is difficult. Ideally the next steps in research like this would be to do a similar study that is national, involving many regions and types of hospital populations (not just academic referral centers). This is not to criticize the PAL-HF trial, it's freaking great, but more to acknowledge that we can't just all go around claiming Palliative Care Improves QOL for HF Patients, Full Stop. As if palliative care is one simple thing, simple intervention, the same everywhere, etc. This is in contradistinction to drug trials. Generalization is a big issue with drug trials too, but it's mostly an issue of extrapolating results to different patient populations (eg community patients to academic center patients, etc). But it's not really a matter of thinking that there's something importantly different about, say, enoxaparin, administered in Loma Linda vs Durham NC. There may very well be important differences in palliative care between Loma Linda and Durham, however. 

I hope those sorts of multi-center trials become more common.

At the end of the day, this is a landmark study. I am really, really glad it was published in a heart journal. We have over a decade of decent research showing the improvements palliative care provides in cancer patients' QOL, but far less in other patient populations, including HF. PAL-HF is a big step towards making the belief that PC benefits patients with HF less up to debate.  

Friday, July 14, 2017 by Drew Rosielle MD ·

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