A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol
Affiliation:
1. Perelman School of Medicine, University of Pennsylvania, Division of General Internal Medicine, Philadelphia 19104, PA, United States;2. Penn Center for Community Health Workers, Penn Medicine, Philadelphia 19104, PA, United States;3. Perelman School of Medicine, University of Pennsylvania, Department of Biostatistics and Epidemiology, Philadelphia 19104, PA, United States;4. Center for Health Equity Research and Promotion, Corporal Michael J. Crescenz VA, Philadelphia 19104, PA, United States;1. Center for Obesity Research and Education, Temple University, 3223 North Broad Street, Suite 175, Philadelphia, PA 19140, USA;2. Puentes de Salud Health and Wellness Center, 1700 South Street, Philadelphia, PA 19146, USA;3. Perelman School of Medicine at the University of Pennsylvania, 3400 Civic Center Boulevard, Philadelphia, PA 19104, USA;4. Department of Epidemiology and Biostatistics, College of Public Health, Temple University, 1301 Cecil B. Moore Avenue, Ritter Annex, 9th Floor, Philadelphia, PA 19122, USA;5. Weight Watchers International, Inc., 675 Avenue of the Americas, 6th Floor, New York, NY 10010, USA;6. Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL 60611, USA;7. Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Drive, 6th Floor, Chicago, IL 60611, USA;1. University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine, 1717 11th Avenue South, Birmingham, AL 35205, USA;2. University of Alabama at Birmingham, Department of Surgery, 1922 7th Avenue South, Birmingham 35233, USA;3. University of Alabama at Birmingham, Department of Family and Community Medicine, 930 20th Street South, Birmingham, AL 35294, USA
Abstract:
Upstream interventions – e.g. housing programs and community health worker interventions– address socioeconomic and behavioral factors that influence health outcomes across diseases. Studying these types of interventions in clinical trials raises a methodological challenge: how should researchers measure the effect of an upstream intervention in a sample of patients with different diseases? This paper addresses this question using an illustrative protocol of a randomized controlled trial of collaborative-goal setting versus goal-setting plus community health worker support among patients multiple chronic diseases: diabetes, obesity, hypertension and tobacco dependence.At study enrollment, patients met with their primary care providers to select one of their chronic diseases to focus on during the study, and to collaboratively set a goal for that disease. Patients randomly assigned to a community health worker also received six months of support to address socioeconomic and behavioral barriers to chronic disease control. The primary hypothesis was that there would be differences in patients' selected chronic disease control as measured by HbA1c, body mass index, systolic blood pressure and cigarettes per day, between the goal-setting alone and community health worker support arms. To test this hypothesis, we will conduct a stratum specific multivariate analysis of variance which allows all patients (regardless of their selected chronic disease) to be included in a single model for the primary outcome. Population health researchers can use this approach to measure clinical outcomes across diseases.Clinical trials registration: ClinicalTrials.gov Identifier: NCT01900470.
