Evaluation of a Telehealth DPP With Medicare Patients at the University of Mississippi Medical Center

PreDiabetes Clinical Trial

Official title: A Telehealth Diabetes Prevention Program in an Academic Medical Center Setting: Hybrid Type III Trial

Status Active, not recruiting

Clinical Trial Summary

The National Diabetes Prevention Program (DPP) is an evidence-based, 12-month lifestyle change program to prevent or delay the onset of type 2 diabetes mellitus (herein referred to as 'diabetes') among adults with prediabetes. The Department of Preventive Medicine, University of Mississippi Medical Center (UMMC), in partnership with the American Medical Association, is collaborating to develop and implement the DPP as a clinical service for UMMC patients beginning in September 2020. We aim to recruit 245 patients per year over 3 years. Because this is the first attempt to develop and implement the DPP as a clinical service at the UMMC, we are proposing to conduct a comprehensive process, outcome, impact and return on investment evaluation. An effectiveness-implementation hybrid research design will be used to (1) evaluate a multifaceted implementation strategy and the effectiveness and impact of the DPP delivered using telehealth by UMMC's Department of Preventive Medicine; (2) conduct an analysis on medical expenditures among those who participate in a DPP to measure net savings and return on investment (ROI) relative to non-participants; (3) conduct a longitudinal cohort analysis to assess incidence of diabetes and changes in body composition, biomarkers, and psycho-social behavioral constructs among those who participate in a DPP relative to those who do not.

The findings from this comprehensive research evaluation will be used to (1) improve clinical operations and implementation; (2) demonstrate the cost benefit of the DPP as a clinical service for patients with diabetes risk; and (3) provide empirical support for delivering the DPP via different modalities including telehealth to reduce risk and improve health outcomes among patients.

Clinical Trial Description

The purpose of this research is to: (1) Evaluate a multifaceted implementation strategy for the uptake of a remote DPP by UMMC's Department of Preventive Medicine. (2) Conduct an analysis on medical expenditures among those who participate in a DPP to measure net savings and ROI relative to non-participants. (3) Conduct a longitudinal cohort analysis to assess incidence of diabetes, body composition, biomarkers, and psycho-social behavioral constructs among those who participate in a DPP relative to those who do not. Study methods are described below according to each of three specific aims.

Aim 1: Conduct a concurrent implementation and effectiveness evaluation of the DPP in a clinical care setting for patients with prediabetes (n=245). An effectiveness-implementation hybrid type III research design will be used to conduct a non-randomized trial with 245 of patients with prediabetes over a three year recruitment period, while employing an iterative process evaluation to explore the complex processes, dynamic context and organizational influences on implementation. The RE-AIM framework will guide the implementation and effectiveness evaluation including measures of Reach, Effectiveness, Adoption, Implementation and Maintenance. Multiple data sources and data types will be used to assess barriers and facilitators that affect the RE-AIM domains, as well as fidelity, costs, patient satisfaction and physician burnout.

Aim 2: Utilize claims and encounters data to measure medical expenditures for patients with prediabetes, and determine spending differentials among DPP participants compared with non-DPP participants. Track trends in per capita medical expenditures for among a panel of case (DPP participant) and control (Non-DPP participant) subjects. To compare variations in spending, the differences in the arithmetic means, compound annual growth rates, and propensity score matching models will be implemented to compare case and control subjects. The study may also look at those with prediabetes that are later diagnosed with diabetes and individuals with prediabetes who are not later diagnosed with the condition. These estimates of spending differentials and evidence of DPP participation and engagement rates will help to further enhance the algorithm to estimate the potential cost savings and ROI if diabetes is prevented or delayed in the at-risk population who participate in the DPP.

Aim 3: Assess the longitudinal effect of the DPP on participant changes in cardiovascular disease risk including anthropometric and clinical biomarker and psychosocial health outcomes (N=245). A prospective, repeated measures, experimental cohort design will be used to determine the long-term impact of the DPP on diabetes incidence and cardiovascular disease risk among DPP patient participants. ;

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

• NCT number: NCT04822480
• Study type: Observational
• Source: University of Mississippi Medical Center
• Status: Active, not recruiting
• Start date: February 1, 2020
• Completion date: December 31, 2024