Project Summary/Abstract
The proposed Latinos Understanding the Need for Adherence in Diabetes using Care
Coordination, Integrated Medical and Behavioral Care and E-Health (LUNA-E) randomized
controlled trial will test the effectiveness of an innovative patient-centered, team-based, primary
care intervention in improving diabetes outcomes in Latino patients of San Ysidro Health (SYH),
a large federally qualified health center (FQHC). The proposal builds on more than 17 years of
research by our academic (San Diego State University; SDSU) community (SYH) partnership.
LUNA-E will recruit and randomize N=400 Latino adults with poorly controlled diabetes into "usual
care plus" (UCP) or "special intervention" (SI). UCP represents methods recently initiated by the
SYH Patient Centered Medical Home initiative, in which a medical assistant provides care
coordination, referrals, and brief health education in collaboration with the primary care provider.
The LUNA-E SI is a highly integrated, culturally specific for diabetes, team-based approach
informed by the Chronic Care Model of healthcare and Resources and Supports for Self-
Management Model of behavior change. The SI includes: 1) Care Coordination by a specially
trained health navigator; 2) Visits with a Behavioral Health Provider with knowledge of diabetes,
local culture, the integrated model, and psychosocial aspects of diabetes care; 3) Care integration
among the Primary Care Provider, Behavioral Health Provider and Care Coordinator via a clinical
decision support “dashboard” in the patient electronic health record (EHR); 4) Evidence-based,
culturally adapted diabetes self-management education delivered via patient portal. The study will
test hypotheses that the LUNA-E SI will lead to larger improvements in glycemic control (HbA1c
levels; Aim 1) and psychological distress (depression and anxiety symptoms; Aim 2) at 6-months
post randomization when compared to UCP, and the degree to which these differences are
explained by conceptually driven mediators (improved resources and supports for self-
management, patient activation, medication adherence and self-management behaviors; Aim 3)
A matched retrospective True Usual Care (TUC) group (N=200) will be extracted from EHR using
propensity score matching, to evaluate diabetes outcomes in UCP and SI versus patients with
little to no care coordination and health education and no study visits. A thorough process
evaluation will assess intervention reach, effectiveness, adoption, implementation, and
maintenance (RE-AIM). LUNA-E has excellent potential for high impact and broad dissemination
due to its community partnered approach, reliance on EHR and E-Health, and implementation
within a large, exemplar FQHC primary care environment.
