A Randomized Controlled Trial of a Community Health Worker Intervention in a Population of Patients with Multiple Chronic Diseases: Study Design and Protocol
Contemporary Clinical Trials 53 (2017) 115–121 Contents lists available at ScienceDirect Contemporary Clinical Trials journal homepage: www.elsevier.com/locate/conclintrial A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol Shreya Kangovi a,b,⁎, Nandita Mitra c, Lindsey Turr a, Hairong Huo a,DavidGrandea, Judith A. Long a,d a Perelman School of Medicine, University of Pennsylvania, Division of General Internal Medicine, Philadelphia 19104, PA, United States b Penn Center for Community Health Workers, Penn Medicine, Philadelphia 19104, PA, United States c Perelman School of Medicine, University of Pennsylvania, Department of Biostatistics and Epidemiology, Philadelphia 19104, PA, United States d Center for Health Equity Research and Promotion, Corporal Michael J. Crescenz VA, Philadelphia 19104, PA, United States article info abstract Article history: Upstream interventions – e.g. housing programs and community health worker interventions– address socioeco- Received 14 September 2016 nomic and behavioral factors that influence health outcomes across diseases. Studying these types of interven- Received in revised form 2 December 2016 tions in clinical trials raises a methodological challenge: how should researchers measure the effect of an Accepted 3 December 2016 upstream intervention in a sample of patients with different diseases? This paper addresses this question using Available online 10 December 2016 an illustrative protocol of a randomized controlled trial of collaborative-goal setting versus goal-setting plus com- munity health worker support among patients multiple chronic diseases: diabetes, obesity, hypertension and to- Keywords: Randomized controlled trial bacco dependence. Upstream medicine At study enrollment, patients met with their primary care providers to select one of their chronic diseases to focus Socioeconomic determinants on during the study, and to collaboratively set a goal for that disease.
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