TY - JOUR
T1 - From Trials to Practice
T2 - Implementing a Clinical Intervention in Community Settings
AU - Vaughan, Elizabeth M.
AU - Yu, Xiaoying
AU - Cardenas, Victor J
AU - Johnston, Craig A.
AU - Virani, Salim S.
AU - Balasubramanyam, Ashok
AU - Ballantyne, Christie M.
AU - Naik, Aanand D.
N1 - Publisher Copyright:
© The Author(s) 2025.
PY - 2025/1/1
Y1 - 2025/1/1
N2 - Introduction/Objectives: Diabetes increases the risk of complications, especially for vulnerable populations. Our previous randomized clinical trial (RCT), TIME (Telehealth-supported, Integrated Community Health Workers (CHWs), Medication access, group visit Education), showed the efficacy of CHW-led diabetes care. This study aimed to gather data on transitioning TIME from clinical trials to practical implementation. Methods: 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. Key Results: 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%]; P =.004; effectiveness) compared to the control. At month 12, more intervention participants improved HbA1c (−0.52% vs 0.25% [δ = 0.8%], P =.062) and preventive care adherence (P <.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. Conclusions: 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.
AB - Introduction/Objectives: Diabetes increases the risk of complications, especially for vulnerable populations. Our previous randomized clinical trial (RCT), TIME (Telehealth-supported, Integrated Community Health Workers (CHWs), Medication access, group visit Education), showed the efficacy of CHW-led diabetes care. This study aimed to gather data on transitioning TIME from clinical trials to practical implementation. Methods: 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. Key Results: 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%]; P =.004; effectiveness) compared to the control. At month 12, more intervention participants improved HbA1c (−0.52% vs 0.25% [δ = 0.8%], P =.062) and preventive care adherence (P <.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. Conclusions: 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.
KW - community clinic
KW - diabetes
KW - diabetes group visits or shared medical appointments
KW - Hispanic or Latino(a)
KW - implementation
KW - patient navigators or community health workers
KW - telehealth
UR - http://www.scopus.com/inward/record.url?scp=105006949917&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=105006949917&partnerID=8YFLogxK
U2 - 10.1177/21501319251339190
DO - 10.1177/21501319251339190
M3 - Article
C2 - 40418742
AN - SCOPUS:105006949917
SN - 2150-1319
VL - 16
JO - Journal of Primary Care and Community Health
JF - Journal of Primary Care and Community Health
M1 - 21501319251339190
ER -