Mentored implementation to initiate a diabetes program in an underserved community: a pilot study

Elizabeth M Vaughan, Aanand D Naik, Amber B Amspoker, Craig A Johnston, Joshua D Landrum, Ashok Balasubramanyam, Salim S Virani, Christie M Ballantyne, John P Foreyt, Elizabeth M Vaughan, Aanand D Naik, Amber B Amspoker, Craig A Johnston, Joshua D Landrum, Ashok Balasubramanyam, Salim S Virani, Christie M Ballantyne, John P Foreyt

Abstract

Introduction: Community clinics often face pragmatic barriers, hindering program initiation and replication of controlled research trial results. Mentoring is a potential strategy to overcome these barriers. We piloted an in-person and telehealth mentoring strategy to implement the Telehealth-supported, Integrated Community Health Workers (CHWs), Medication-access, group visit Education (TIME) program in a community clinic.

Research design and methods: Participants (n=55) were low-income Latino(a)s with type 2 diabetes. The study occurred in two, 6-month phases. Phase I provided proof-of-concept and an observational experience for the clinic team; participants (n=37) were randomized to the intervention (TIME) or control (usual care), and the research team conducted TIME while the clinic team observed. Phase II provided mentorship to implement TIME, and the research team mentored the clinic team as they conducted TIME for a new single-arm cohort of participants (n=18) with no previous exposure to the program. Analyses included baseline to 6-month comparisons of diabetes outcomes (primary outcome: hemoglobin A1c (HbA1c)): phase I intervention versus control, phase II (within group), and research-run (phase I intervention) versus clinic-run (phase II) arms. We also evaluated baseline to 6-month CHW knowledge changes.

Results: Phase I: compared with the control, intervention participants had superior baseline to 6-month improvements for HbA1c (mean change: intervention: -0.73% vs control: 0.08%, p=0.016), weight (p=0.044), target HbA1c (p=0.035), hypoglycemia (p=0.021), medication non-adherence (p=0.0003), and five of six American Diabetes Association (ADA) measures (p<0.001-0.002). Phase II: participants had significant reductions in HbA1c (mean change: -0.78%, p=0.006), diastolic blood pressure (p=0.004), body mass index (0.012), weight (p=0.010), medication non-adherence (p<0.001), and six ADA measures (p=0.007-0.005). Phase I intervention versus phase II outcomes were comparable. CHWs improved knowledge from pre-test to post-tests (p<0.001).

Conclusions: A novel, mentored approach to implement TIME into a community clinic resulted in improved diabetes outcomes. Larger studies of longer duration are needed to fully evaluate the potential of mentoring community clinics.

Keywords: community medicine; health services research; medication adherence; telemedicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials diagram of phase I and phase II. *Lost to follow-up defined as the inability to contact the participant at month 6. HbA1c, hemoglobin A1c.
Figure 2
Figure 2
Comparison of hemoglobin A1c (HbA1c) levels by study phase and arm (represents HbA1c levels of individuals who started the study uncontrolled, for example, HbA1c >7%25). Phase I intervention (mean change −1.03%, 95% CI (−1.5 to −0.5)) versus control (mean change 0.04%, 95% CI (−0.7 to 0.8)), (p=0.011); Phase II (mean change −1.34%, 95% CI (−2.0 to −0.7)), (p=0.001)).
Figure 3
Figure 3
Community health worker (CHW) pre-test and post-test by individual and overall (max score=49) (p

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