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. 2014 Dec;48(6):1021-30.
doi: 10.1016/j.jpainsymman.2014.04.008. Epub 2014 May 23.

Strategies to support recruitment of patients with life-limiting illness for research: the Palliative Care Research Cooperative Group

Laura C Hanson  1 , Janet Bull  2 , Kathryn Wessell  3 , Lisa Massie  2 , Rachael E Bennett  4 , Jean S Kutner  4 , Noreen M Aziz  5 , Amy Abernethy  6
Affiliations

Strategies to support recruitment of patients with life-limiting illness for research: the Palliative Care Research Cooperative Group

Laura C Hanson et al. J Pain Symptom Manage. 2014 Dec.

Abstract

Context: The Palliative Care Research Cooperative Group (PCRC) is the first clinical trials cooperative for palliative care in the U.S.

Objectives: To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial.

Methods: The parent study was a multisite randomized controlled trial enrolling adults with life expectancy anticipated to be one to six months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semistructured interviews with 18 site principal investigators (PIs) and clinical research coordinators (CRCs) and reviewed recruitment rates. Interviews covered three topics: 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC.

Results: All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of 381 patients. Site enrollment ranged from 1 to 109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients' needs, support from clinical champions, and the additional resources of a trials cooperative group.

Conclusion: The recruitment experience from the multisite PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field.

Keywords: Palliative care; clinical trials; recruitment; research networks.

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Conflict of interest statement

DISCLOSURES AND CONFLICTS OF INTERESTS:

Dr. Hanson has research funding from the National Institute of Nursing Research, the National Institute on Aging, and the National Heart, Lung and Blood Institute. Funds are distributed to the University of North Carolina for salary and research support. Further consulting is pending for the Research Triangle Institute.

Dr. Abernethy has research funding from the National Institute of Nursing Research, National Cancer Institute, Agency for Healthcare Research and Quality, DARA, Glaxo Smith Kline, Celgene, Helsinn, Dendreon and Pfizer; these funds are all distributed to Duke University Medical Center to support research including salary support for Dr. Abernethy. Pending industry funded projects include: Genentech, Bristol Myers Squibb, Insys, and Kanglaite. In the last 2 years she has had nominal consulting agreements with or received honoraria from (<$10,000 annually) Novartis, Bristol Myers Squibb and Pfizer. Further consulting with Bristol Meyers Squibb is pending in 2013, for role as Co-Chair of a Scientific Advisory Committee. Dr. Abernethy has a paid leadership role with American Academy of Hospice & Palliative Medicine (President). She has corporate leadership responsibility in AthenaHealth (health IT company), Advoset (an education company that has a contract with Novartis), and Orange Leaf Associates LLC (an IT development company).

Dr. Kutner has research funding from the National Institute of Nursing Research, National Cancer Institute, Agency for Healthcare Research and Quality. She is supported by the Informed Medical Decisions Foundation (IMDF) in her role as Medical Editor. All of these funds are all distributed to University of Colorado School of Medicine to support research including salary support for Dr. Kutner.

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Palliative Care Research Cooperative Group (PCRC)
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