title: A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol.
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.
  
  
  
  ClinicalTrials.gov Identifier: NCT01900470.
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Division of General Internal Medicine, Philadelphia 19104, PA, United States; Penn Center for Community Health Workers, Penn Medicine, Philadelphia 19104, PA, United States. Electronic address: kangovi@mail.med.upenn.edu.
authors.forename: Shreya
authors.initials: S
authors.lastname: Kangovi
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Department of Biostatistics and Epidemiology, Philadelphia 19104, PA, United States. Electronic address: nanditam@mail.med.upenn.edu.
authors.forename: Nandita
authors.initials: N
authors.lastname: Mitra
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Division of General Internal Medicine, Philadelphia 19104, PA, United States. Electronic address: lindsey.turr@uphs.upenn.edu.
authors.forename: Lindsey
authors.initials: L
authors.lastname: Turr
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Division of General Internal Medicine, Philadelphia 19104, PA, United States. Electronic address: huoh@mail.med.upenn.edu.
authors.forename: Hairong
authors.initials: H
authors.lastname: Huo
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Division of General Internal Medicine, Philadelphia 19104, PA, United States. Electronic address: dgrande@wharton.upenn.edu.
authors.forename: David
authors.initials: D
authors.lastname: Grande
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Division of General Internal Medicine, Philadelphia 19104, PA, United States; Center for Health Equity Research and Promotion, Corporal Michael J. Crescenz VA, Philadelphia 19104, PA, United States. Electronic address: jalong@mail.med.upenn.edu.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Long
mesh_terms: D003150:Community Health Workers; D003920:Diabetes Mellitus / Q000628:therapy*; D019468:Disease Management; D006040:Goals; D006801:Humans; D006973:Hypertension / Q000628:therapy*; D000071069:Multiple Chronic Conditions / Q000628:therapy*; D009765:Obesity / Q000628:therapy*; D010347:Patient Care Planning; D064890:Social Determinants of Health; D012944:Social Support; D014029:Tobacco Use Disorder / Q000628:therapy*
keywords: Randomized controlled trial; Socioeconomic determinants; Upstream medicine