Monday, February 14, 2011

Heart Failure and Palliative Care

NIH has a RFA out on Palliative Care and Heart Failure. The August 2010 publication of a randomized control trial of early palliative care for stage 4 lung cancer showed that those receiving early care had longer survival, improved quality of life and reduced costs got a great deal of attention and helped increase the policy attention paid to expanding access to palliative care. Palliative care addresses symptoms and quality of life regardless of prognosis.

Hospice is a multi-disciplinary approach to providing palliative care to persons who are believed to be in the last 6 months of their life. Hospice is a subset of palliative care, but is not synonymous with palliative care.

The RCT of palliative care described above was particularly notable because patients did not unelect curative treatments as they must if they choose hospice in the Medicare program, but instead, patients in the treatment group were simply referred to the palliative medicine service within 1 week of diagnosis of their lung cancer as being stage 4. They were eligible to receive any treatments, be it chemotherapy, radiation or otherwise. They could also decide to stop receiving such treatments. In policy terms, this is known as concurrent palliative care, or the treatment of symptoms and focus on patient goals alongside treatments designed to forestall the Cancer.

One of the calls after the publication of the Temel et al. study was for replication of this study in other diseases. This is particularly important because Cancer generally has a more predictable time course to death than do other diseases, such as congestive heart failure, or dementia. This has an impact on how palliative care could best be offered, and it likely differs across diseases. In policy terms, at least some of the discussion and debate over long stays in hospice and whether this represents inappropriate or even fraudulent care is related to the increasing use of hospice by persons with congestive heart failure (CHF) and dementia (diseases with a more ambiguous prognosis).

If Cancer is the most predictable disease (and that doesn't mean it is predictable, just comparatively so), then CHF may be the least predictable, with a series of crisis events, one of which eventually ends in death. At the same time, CHF results in a great deal of suffering for patients, and palliative care has lots to offer patients. So, this RFA is timely and important.

I am hopefully working with colleagues at Duke to put together a RCT of early palliative care with CHF patients. I see two huge issues/problems with this type of study, one related to CHF and the other related to palliative care.
  • When do you randomize CHF patients? There is not a diagnostic point as 'clean' as the identification of a stage 4 lung cancer at which to randomize patients to early palliative care or the control group of normal care. There are many clinical possibilities (not my area so won't wade into the details) but this will be a tricky part of doing such a study well with CHF patients.
  • What are patients being randomized to? I sat in on a broad ranging discussion of some stakeholders of the Duke Cancer Care Research Program about two months ago talking about research priorities and protocols. One point that came up (it wasn't the main point of the discussion, but this RFA triggers it for me) was how specific RCT of pharmaceuticals or chemotherapy agents must be. Exactly how much is given, when, how, by whom, etc. But a randomization to a palliative care service is less clear. In the context of pharmaceutical RCTs, often a control group is access to 'best supportive care' which may mean access to a palliative care service. In the context of this RFA, palliative care is the treatment, so needs to be nailed down and replicable. One of the points of palliative care is to listen to patient goals and to even help patients identify their goals given the reality of the disease process. The choices or outcomes won't be the same across patients, but of course that is also true with RCTs of pharmaceuticals, that is why you do them. But, there doesn't seem to be as much experience is nailing down what is meant by palliative care or best supportive care in the control arm of other studies. Getting straight what patients are randomized to will be a big part of doing this well.

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