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

Area of Science:

• Implementation science
• Community health
• Diabetes management

Background:

• Diabetes poses significant risks, particularly for vulnerable populations.
• Previous research demonstrated the efficacy of the TIME (Telehealth-supported, Integrated Community Health Workers (CHWs), Medication access, group visit Education) program.
• This study focused on translating the TIME program from clinical trials to real-world application.

Purpose of the Study:

• To evaluate the practical implementation of the TIME program in a community clinic setting.
• To gather data on the transition of a CHW-led diabetes care model from research to practice.
• To assess implementation measures including acceptability, adoption, cost, feasibility, fidelity, satisfaction, and effectiveness.

Main Methods:

• A 12-month randomized clinical trial (RCT) involving 58 uninsured Hispanic adults with type 2 diabetes.
• Participants were randomized to the TIME intervention or usual care.
• The TIME intervention included telehealth-supported group visits and mHealth contact with CHWs, guided by the Consolidated Framework for Implementation Research (CFIR).

Main Results:

• High fidelity (88.2% CHW-participant contact success), feasibility (3.4% attrition), and cost savings ($16,435 net savings).
• Significant HbA1c reductions observed in the intervention group at 6 months (-0.85% vs 0.35%, P=.004) and sustained at 12 months (-0.52% vs 0.25%, P=.062).
• High appropriateness, satisfaction, and acceptability reported by providers, CHWs, and participants.

Conclusions:

• The TIME program successfully met key implementation benchmarks, showing strong engagement and cost-effectiveness.
• The findings support the transition of the TIME model from efficacy trials to scalable, community-based diabetes care.
• Further research with larger studies is recommended to validate these implementation outcomes.