Creation and demonstration of a collaborative, multi-site, palliative care research network to reinvigorate biomedical research in Palliative Medicine

We propose to cultivate new collaborations among established investigators, and to assemble a new multidisciplinary team, to facilitate the conduct of innovative, high-impact, clinically relevant research in one of the most challenging biomedical and behavioral areas – palliative care. While developing policies and procedures for inter-institutional, collaborative research, this project will also test the collaborative network and refine its methods through the design and conduct of a specific study addressing clinical uncertainty regarding withdrawal of lipid-lowering agents in the palliative care setting. This study, conducted in the context of a new national cooperative research network, will broaden our research base and enhance cross-fertilization. At the conclusion of the funding period, we expect to have both (1) completed the planned investigation, and (2) created a unique and innovative palliative care cooperative group that is sustainable, poised to conduct multiple future studies, and prepared to serve as a venue for recruiting new investigators and new expertise into the palliative care research community. An embedded clinical trial will serve as a focal point for development of the cooperative group. We propose a randomized comparative effectiveness study that is intended to provide important evidence regarding a standard, but unstudied, palliative care practice – withdrawal of medications for medical comorbidities as death nears. We focus on HMG Co-A reductase inhibitors (a.k.a., statins), prescribed for the primary or secondary prevention of hyperlipidemia, since they are common medications and their withdrawal is a source of major debate. Recommendations for their withdrawal have been proposed, but never tested. Specific aims include: 1. To determine if there is a difference in time-to-event in patients who are discontinued on statins vs. maintained on statins, as assessed via a composite endpoint encompassing death and major cardiovascular events (e.g., myocardial infarction, stroke). 2. To determine whether there are differences in patient- and family-perceived burden, and quality of life of patients and family/caregivers, when patients have statins withdrawn versus when patients continue on statins. 3. To assess the difference in cost between patients who have statins withdrawn versus those who continue on statins. UNC-CH will be a subcontractor for this work.

Principal Investigator: Laura Hanson, MD, MPH

Funding: Duke University Medical Center via NIH

Total Project Period: 09/01/2010 – 09/29/2013