Knowledge deficits related to pain management persist in nursing homes. An interactive multifaceted educational program was only partially successful in improving knowledge across settings and job categories. Attitudes and beliefs appear more difficult to change, whereas environmental and contextual factors appeared to be reducing perceived barriers to effective pain management across all participating nursing homes.
Researchers conducting multi-site studies of interventions for end-of-life symptom management face significant challenges with respect to obtaining an adequate sample and training and retaining on-site study teams. The purpose of this paper is to describe the strategies and responses to these challenges in a multi-site randomized clinical trial (RCT) of the efficacy of massage therapy for decreasing pain among patients with advanced cancer in palliative care/hospice settings. Over a period of 36 months, we enrolled 380 participants across 15 sites; 27% of whom withdrew prior to study completion (less than the anticipated 30% rate). We saw an average of 68% turnover amongst study staff. Three key qualities characterized successful on-site study teams: (1) organizational commitment; (2) strong leadership from on-site study coordinators; and (3) effective lines of communication between the on-site study coordinators and both their teams and the university-based research team. Issues of recruitment, retention and training should be accounted for in hospice-based research study design and budgeting.Overview of the REST (Reducing End-of-Life Symptoms with Touch) Study I n 2003, researchers from the University of Colorado Denver Schools of Medicine and Nursing received funding from the National Institutes of Health (NCCAM-1 R01 AT01006-01A2) to conduct a multi-site randomized clinical trial (RCT) to examine the efficacy of massage therapy for decreasing pain, improving quality of life, and lessening symptom distress in people with advanced cancer. Fifteen organizations, 14 of which were hospices and members of a national palliative care practice-based research network 1 served as study sites. Patients from these sites who were eligible and consented were randomly assigned to receive massage therapy (intervention) or the control condition, simple touch. Both treatment arms followed similar protocols which included up to six 30-minute treatment sessions over a 2-week period. At each site a team of committed hospice employees or volunteers implemented the study procedures. Participants receiving massage therapy had significantly greater immediate improvement in pain and mood; differences that were not sustained over time. Participants in both study arms experienced some improvement in pain and symptom distress over the course of their study enrollment; use of pain medications remained stable. 2 Methodologic ChallengesObtaining an adequate and appropriate sampleIn designing and implementing the REST study, we encountered the common challenge of obtaining an adequate sample. Participant recruitment may be difficult in any clinical trial; characteristics of the hospice/palliative care environment present unique challenges. Despite palliative care/hospice studies devoting significant time and resources to participant recruitment, sample sizes are often smaller than anticipated. [3][4][5] Researchers may significantly modify study designs to maintain trial viability. 6 In the REST study, we planned for a sample size of...
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