Why Effective Interventions Do Not Work for All Patients: Exploring Variation in Response to a Chronic Disease Management Intervention.

BACKGROUND: Half of all Americans have a chronic disease. Promoting healthy behaviors to decrease this burden is a national priority. A number of behavioral interventions have proven efficacy; yet even the most effective of these has high levels of nonresponse. OBJECTIVES: In this study, we explore variation in response to an evidence-based community health worker (CHW) intervention for chronic disease management. RESEARCH DESIGN: We used a convergent parallel design that combined a randomized controlled trial with a qualitative process evaluation that triangulated chart abstraction, in-depth interviews and participant observation. SUBJECTS: Eligible patients lived in a high-poverty region and were diagnosed with 2 or more of the following chronic diseases: diabetes, obesity, hypertension or tobacco dependence. There were 302 patients in the trial, 150 of whom were randomly assigned to the CHW intervention. Twenty patients and their CHWs were included in the qualitative evaluation. RESULTS: We found minimal differences between responders and nonresponders by sociodemographic or clinical characteristics. A qualitative process evaluation revealed that health behavior change was challenging for all patients and most experienced failure (ie, gaining weight or relapsing with cigarettes) along the way. Responders seemed to increase their resolve after failed attempts at health behavior change, while nonresponders became discouraged and "shut down." CONCLUSIONS: Failure is a common and consequential aspect of health behavior change; a deeper understanding of failure should inform chronic disease interventions.

A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol.

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.

Decision-making and goal-setting in chronic disease management: Baseline findings of a randomized controlled trial.

OBJECTIVE: Growing interest in collaborative goal-setting has raised questions. First, are patients making the 'right choices' from a biomedical perspective? Second, are patients and providers setting goals of appropriate difficulty? Finally, what types of support will patients need to accomplish their goals? We analyzed goals and action plans from a trial of collaborative goal-setting among 302 residents of a high-poverty urban region who had multiple chronic conditions. METHODS: Patients used a low-literacy aid to prioritize one of their chronic conditions and then set a goal for that condition with their primary care provider. Patients created patient-driven action plans for reaching these goals. RESULTS: Patients chose to focus on conditions that were in poor control and set ambitious chronic disease management goals. The mean goal weight loss -16.8lbs (SD 19.5), goal HbA1C reduction was -1.3% (SD 1.7%) and goal blood pressure reduction was -9.8mmHg (SD 19.2mmHg). Patient-driven action plans spanned domains including health behavior (58.9%) and psychosocial (23.5%). CONCLUSIONS: High-risk, low-SES patients identified high priority conditions, set ambitious goals and generate individualized action plans for chronic disease management. PRACTICE IMPLICATIONS: Practices may require flexible personnel who can support patients using a blend of coaching, social support and navigation.