Wednesday, September 9, 2009
PC Trial in JAMA
Well, summer's over, Congress is back in session, the President is talking health care reform tonight, and I feel like some mundane posts on journal articles. I have developed an impressive backlog of things to blog about during my real-life and then blog-only vacation the last few weeks, and it may soon be time for the fall Mag Citrate session, we'll see.
JAMA recently published a trial of a palliative care intervention for advanced cancer patients. It was called the Project Enable II and was a RCT of advanced cancer patients (n=330 which was a 47% participation rate, mean age 65 years and mean Karnofsky 77%, all patients were at two academic centers in Vermont, all within 12 weeks of diagnosis of an advanced solid tumor malignancy - they said with a diagnosis of approximately 1 year although it's unclear how this was determined). They were randomized to either usual care (including ad hoc palliative care referrals, etc.) or a palliative care case management/patient education package, and were followed over time.
The intervention is complex and tough to summarize: it involved telephone symptom assessment, education, counseling, and care coordination (e.g. organizating appropriate referrals) for these patients by a nurse practitioner. There was a heavy self-problem solving element as well (see here - the Charting Your Course handbook halfway down for more details). Phone calls were monthly and lasted 30-40 minutes.
Health related quality of life (via FACIT-Pal) and mood were modestly improved in the intervention group compared to control. Survival (14 vs 8.5 months) and global symptom burden were improved in the treatment group as well - not-statistically significantly however despite the marked difference in median survival. They reported no differences in resource use (days in hospital, ED visits etc.) between groups; rates of enrollment and length of stay in hospice weren't reported.
A few things of note:
- The trial is important as it represents a trial of early palliative care involvement (from the time of diagnosis, or nearly) - it tries to exemplify the 'concurrent care' model most of us have been trying to move towards a long time now (as opposed to the 'I've got nothing left to offer you' hand-off to palliative care model). And it's gratifying to note that this model provided some modest benefits, and while it will surprise no one who practices palliative care that survival was similar, if not improved with the palliative care intervention, it's been the sort of month in which any non-threatening news about palliative care is welcome (and this is about as non-threatening as it comes; 'we' make people feel better with no impact on anything else including resource utilization). These are the sort of findings which kind of make you want to be a wee bit threatening.
- But is this palliative care? On the one hand, sure, and it sounds like a worthwhile project which improved the lives of those patients who received it. But this is very different from 'palliative care' as it's actually practiced, in the US, in cancer centers and hospitals (which involves, you know, clinicians seeing patients). The intervention package, as described, is complex and comprehensive enough to make generalization of it (other than if one were to enact the project wholesale) impossible. One also wonders if this falls into the grand, and rapidly expanding category of 'studies which show people feel better if you call them frequently and talk with them about what they're struggling with' (cf here).
- And so - why JAMA? This is not to denigrate the importance of the paper and study - certainly any well done randomized controlled trial that has anything to do with palliative care is of note for those in the field, but for a general audience? I've been puzzling over this one for a while, as it's been a long time since JAMA published some original palliative-centric research (CWCS is the last I can recall), and certainly a lot of the palliative research that's been put out in Archives the last year would be of equal interest to a general audience (here, here)? And while my lack of imagination should never be assumed to be anything more than that, it's tough for me to see the interest of this for a general audience? PC doesn't do much? PC improves QOL? PC doesn't affect survival? PC doesn't effect resource utilization? An abiding interest amongst the JAMA editors in patient problem solving/self-empowerment interventions?
3 Responses to “PC Trial in JAMA”
September 10, 2009
Thanks for opening this up, Drew--it's been on my mind for the past couple of weeks. I hadn't known about the ENABLE II study before seeing this JAMA article (the lead, no less), and I share some concerns about how the study could be interpreted.
To start, I agree with you that the ENABLE intervention is not interdisciplinary palliative care as most of us practice it. A phone-only relationship with an APN once monthly (even if the nurse is well-trained in palliative care and has a developed toolkit) looks much like the long-studied 'disease management' model, which is losing support among health policy folks and CMS adminsitrators. A systematic review of 15 such programs was published earlier this year in JAMA (2009; 301(6):603-618--also a lead article, interestingly), concluded that they had minimal to no impact on important outcomes such as care quality, adherence, hospitalizations and cost.
On the slightly brigher side, the few trends toward positive outcomes occur in disease management programs with higher intensity in-person components that target patients with higher needs--something that looks perhaps more like fully realized palliative care and hospice IDT care.
I want to be clear that I have no fundamental criticism of ENABLE II--it was designed to do just what it did, and in a rural population for whom phone contact was perhaps the only practically available approach. It also confirms that an isolated phone-based intervention may not be any more successful in a palliative care setting than it is in other disease managment programs. This is valuable evidence as we try to evolve mature, broadly sustainable models of integrated palliative care.
There is a risk, however, that a high-profile portrayal of 'palliative care' as a narrow, almost ancillary intervention with such a modest impact (mood and QOL effects notwithstanding) will lead some to doubt the effectiveness of our practice, particularly if they have pre-existing skepticism about HPM. Disease management programs are not only fading from CMS favor, but they are on the chopping block at many institutions.
I would hope for some vigorous letters to the editor in response, putting this study into the broader context of HPM in the US.
Anyone writing?
September 14, 2009
It's important to note that both the control and the experimental group were allowed to see palliative care clinicians as their providers saw fit. I agree this is not a trial evaluating the effectiveness of PC. In fact, I think the research designers may have been saying, Pall Care is so accepted in the standard of care that we can't randomize it. Instead this is a study looking at whether skilled RNs who perform monthly phone triage provide meaningful benefit for advanced cancer patients. I even take issue with the language "palliative care intervention" that is used in the title.
Personally, I'm not sure what to make of this. I'm sure all specialists would find it comforting and helpgul to have dedicated, skilled RNs call their complicated patients and provide well-thought out assessment, advise and care coordination. I'm just not convinced, however, that this study proves its effectivenss in such a way that we should change our practice and the way we utilize our resources and time to do all this.
This leads me to the same question, why was this, essentially negative study, a lead article in JAMA? My concern is, it had something to do with the timing of the national political discourse.
September 15, 2009
PR: thanks for supplying that improtant context about disease management and the CMS, and I agree completely with your concerns about this misleading skeptics (or the uninitiated) about what palliative care is, and can do.
And SM I too have no idea why it got into JAMA. As I said in the post there is a brisk flow of fascinating, and broadly interesting palliative care-related research coming out in general journals....
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