From Trials to Practice: Implementing a Clinical Intervention in Community Settings.

Abstract

Diabetes increases the risk of complications, especially for vulnerable populations. Our previous randomized clinical trial (RCT), TIME (<u>T</u>elehealth-supported, <u>I</u>ntegrated Community Health Workers (CHWs), <u>M</u>edication access, group visit <u>E</u>ducation), showed the efficacy of CHW-led diabetes care. This study aimed to gather data on transitioning TIME from clinical trials to practical implementation. We conducted a 12-month RCT at a nonprofit community clinic using the Consolidated Framework for Implementation Research (CFIR). Participants, Hispanic adults without insurance and with type 2 diabetes (N = 58; 29/arm), were randomized to TIME (intervention) or usual care (control). The intervention included monthly group visits and weekly CHW mHealth contact (6 months, Action Phase), followed by quarterly visits and bi-monthly mHealth contact (6 months, Maintenance Phase). The research team provided tele-mentoring to the clinic team throughout the intervention. Outcomes included implementation measures including acceptability, adoption, appropriateness, cost, feasibility, fidelity, satisfaction, and effectiveness. The program showed high levels of fidelity (direct observation), adoption (CHW-participant contact: 844 successes of 957 attempts [88.2%]), and feasibility (3.4% attrition). The intervention's net savings was $16,435 ($566/participant). At 6 months, intervention participants had greater HbA1c reductions (-0.85% vs 0.35% [δ = 1.2%]; <i>P</i> = .004; effectiveness) compared to the control. At month 12, more intervention participants improved HbA1c (-0.52% vs 0.25% [δ = 0.8%], <i>P</i> = .062) and preventive care adherence (<i>P</i> < .0001) compared to the control. Surveys revealed high appropriateness (mean = 4.8/5.0 and 5.95/6.0), satisfaction (mean = 4.6/5.0), and acceptability (mean = 4.9/5.0) among providers, CHWs, participants, and stakeholders. TIME met key early implementation measures, including strong engagement at both clinic and participant levels, while demonstrating cost savings and significant clinical improvements. These results support the transition of TIME from efficacy trials to practical, community-based diabetes care. Larger studies are needed to further evaluate these findings.