Contemporary Clinical Trials Communications (Jun 2021)
Bridge to Health/ Puente a la Salud: Rationale and design of a pilot feasibility randomized trial to address diabetes self-management and unmet basic needs among racial/ethnic minority and low-income patients
Abstract
Introduction: Racial/ethnic and socioeconomic disparities in diabetes prevalence and management persist. Unmet basic needs such as food insecurity and unstable housing interfere with optimal diabetes self-management. Bridge to Health/Puente a la Salud is a randomized pilot trial designed to examine the feasibility of testing the effectiveness of addressing unmet basic needs via navigation services versus navigation plus diabetes self-management support (DSMS) on improving diabetes-related outcomes among racial/ethnic minority and low-income patients with uncontrolled diabetes. Material and methods: We recruited and randomized 110 African American, Hispanic, and Medicaid patients (any race/ethnicity) with diabetes and recent hemoglobin A1C ≥ 8% to one of two 6-month interventions: 1) Navigation only; or 2) Navigation + DSMS. In both arms, practice-embedded patient navigators help participants navigate social services and community-based resources to address unmet basic needs. In Navigation + DSMS, participants are also assigned to a community health worker (CHW) embedded in a local community-based organization who provides additional navigation support and delivers DSMS. A1C and unmet basic needs data are collected via routine lab and survey, respectively, at baseline and 6-month follow-up. Qualitative interviews with participants, health system leaders, CHWs, and patient navigators are conducted to explore intervention acceptability and determinants of implementation in a health care setting. Discussion: Findings from this pilot feasibility study will enhance understanding about acceptability, preliminary clinical effectiveness, and facilitators and barriers to implementation of the Navigation only and Navigation + DSMS interventions and inform refinements of the overall study design for the larger, randomized clinical trial.
