Promotora assisted depression care among predominately Hispanic patients with concurrent chronic illness: Public care system clinical trial design

Depression frequently negatively affects patient overall self-care and social stress management within United States safety net care systems. Rates of major depression are significantly high among low-income predominantly Hispanic/Latino with chronic illness, such as diabetes and heart disease. The study design of the A Helping Hand to Activate Patient-Centered Depression Care among Low-income Patients (AHH) randomized clinical trial aims to enhance patient depression care receipt and overall bio-psychosocial self-care management. The AHH trial is conducted in collaboration with three Los Angeles County Department of Health Services (DHS) safety net clinics that provide Patient-Centered Medical Home (PCMH) care. The study compares AHH intervention (AHH) in which community-based bilingual promotoras provide in-person or telephone patient engagement and intervention aimed to reduce the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management skill, and activating patient communication with clinic medical providers versus DHS PCMH team usual care (PCMHUC). AHH independent bilingual recruiters screened 1957 and enrolled 348 predominantly Hispanic/Latino patients, of whom 296 (85%) had diabetes, 14 (4%) with heart disease, and 38 (11%) with both diseases. Recruiters identified depressed patients by baseline Patient Health Questionnaire-9 scores of 10 or more, completed baseline assessments, and randomized patients to either AHH or PCMHUC study group. The comprehensive assessments will be repeated at 6 and 12 months by an independent bilingual follow-up interviewer. Baseline and outcome data include mental health assessment and treatment receipt, co-morbid illness self-care, social relationships, and environmental stressor assessments.