Barriers and solutions to implementing a pragmatic diabetes education trial in rural primary care clinics

Contemp Clin Trials Commun. 2020 Mar 3:18:100550. doi: 10.1016/j.conctc.2020.100550. eCollection 2020 Jun.

Abstract

Introduction: The purpose of this report is to describe barriers and solutions to the implementation and optimization of a pragmatic trial that tests an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care in rural primary care clinics.

Methods: The two-arm pragmatic trial has been implemented in six rural family medicine clinics in Arkansas. It tests a self-management education and counseling intervention for patients with type 2 diabetes compared to enhanced usual care. Barriers and solutions were identified as issues arose and through interviews with clinic directors and clinic administrators and a focus group, interviews, and tracking reports with clinic health coaches who delivered the intervention.

Results: Barriers to optimizing enrollment, intervention delivery, and data collection were addressed through targeted education of and relationship building with leadership, changing enrollment oversight, and ongoing training of health coaches.

Conclusions: Successful implementation and optimization of this pragmatic clinical trial in rural primary care clinics was achieved through establishing common goals with clinic leadership, minimizing demands on clinic staff and administration, frequent contact and ongoing support of health coaches, and collaborative troubleshooting of issues with delivering the intervention.

Keywords: Diabetes; Health literacy; Patient-centered medical home; Pragmatic trial; Pragmatic trial optimization; Rural.