Palliative care, a relatively new subspecialty, needs to build its evidence base supporting clinical practice. The Institute of Medicine has identified palliative care as a comparative effectiveness research priority, but increased scientific productivity is impeded by challenges to research in this field. In addition to factors such as gate-keeping by clinicians/caregivers, patients'fragility, and short prognoses causing attrition, the lack of research infrastructure in palliative medicine presents a major hurdle. Without a "research engine," studies in palliative care are often not robust in design and methods, have difficulty recruiting, and produce data of questionable utility. Palliative care needs a structure for the conduct of high-quality clinical trials;this structure should be scalable, offer support and up-scaling to new investigators and sites, and answer important clinical questions. We propose to create such a structure - a national collaborative research network in palliative care - and to demonstrate the value of the collaborative for research productivity by conducting a multi-site clinical trial that studies a consensually selected, clinically relevant topic in palliative care. The grant's first aim focuses on establishing a unique, innovative, palliative care research cooperative (PCRC) group that: is sustainable;convenes and fosters collaboration between experienced multidisciplinary investigators;facilitates innovative, high-impact, clinically useful research;responds to recognized challenges faced by cooperative research groups in the past;and, serves as a venue for recruiting new investigators and new expertise into the palliative care research community. Further aims are defined within the context of a randomized comparative effectiveness study that will provide evidence regarding a standard, but unstudied, palliative care practice - discontinuation of medications for co-morbidities as death nears. The study population is patients with a life-limiting illness who are on lipid-lowering agents (HMG Co-A reductase inhibitors, a.k.a. statins) prescribed for primary or secondary prevention. Statins are common medications (prescribed for >25% of Medicare beneficiaries), and their discontinuation is a source of major debate. Enrolling patients at 11 sites nationally, the trial will determine if there is a difference in survival time (i.e., time to death) in patients who discontinue statins vs. continue on statins. Additionally, we will evaluate potential differences in adverse events (e.g., hospitalization for cardiovascular events), symptoms, polypharmacy, satisfaction with care, quality of life, and cost when statins are withdrawn vs. continued. This grant coalesces many medical disciplines and clinical researchers. For feasibility reasons, the trial is deliberately chosen to address a simple research question with a clean study design, while yielding information that is vitally important to clinical practice and health policy. Completion of the project will definitively answer an important clinical uncertainty, and also establish the cooperative group as a national infrastructure for the conduct of high-quality, multi-disciplinary, clinical trials in palliative care.

PUBLIC HEALTH RELEVANCE: Many important clinical questions remain unanswered in palliative care, due to the lack of research infrastructure in this field. We will: (1) establish a national cooperative group to support high-quality, multi-site, collaborative research addressing clinically relevant topics in palliative care, and;(2) test the collaborative through a clinical trial addressing the question of whether or not to discontinue statins as patients near death.

UC4NR012584

2010-09-30

2013-09-29