A Telehealth Diabetes Prevention Program in an Academic Medical Center Setting: Hybrid Type III Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PreDiabetes
- Sponsor
- University of Mississippi Medical Center
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Hemoglobin A1c
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Abigail Gamble
Assistant Professor of Preventive Medicine and Population Health Science
University of Mississippi Medical Center
Eligibility Criteria
Inclusion Criteria
- •UMMC patient within the previous 3-years (at least one UMMC clinical visit within the previous 3-years)
- •≥ 18 years AND
- •Clinical diagnosis for prediabetes (R73.03)
- •OR any of the following combinations:
- •BMI ≥25 (non-Asian) OR
- •BMI ≥23 (Asian) AND
- •HbA1c 5.7 - 6.4 percent within the past 12-months OR
- •Fasting plasma glucose 110 - 125 mg/dL within the past 12-months OR
- •2-hour plasma glucose 140 - 199 mg/dL within the past 12-months
Exclusion Criteria
- •Pregnant or planning to become pregnant within the next 12 months
- •\<18 years
- •Primary or secondary diagnosis of diabetes mellitus (all codes with prefix of 250 and 249) and other conditions associated with diabetes (357.2, all codes with prefix 362, 366.41, and all codes with prefix 648).
- •End stage renal disease
Outcomes
Primary Outcomes
Hemoglobin A1c
Time Frame: Change in HbA1c from baseline to 36-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
2-hour plasma glucose
Time Frame: Change in 2-hour plasma glucose from baseline to 36-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Type 2 diabetes mellitus diagnosis
Time Frame: Change diabetes diagnosis from baseline to 36-months in DPP compared with non-DPP patients
Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
Fasting plasma glucose
Time Frame: Change in fasting plasma glucose from baseline to 36-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Medical encounters
Time Frame: Number of medical encounters between baseline and 36-months in DPP compared with non-DPP patients
Extracted from electronic health record
Medical expenditures
Time Frame: Medical expenditures from baseline to 36-months in DPP compared with non-DPP patients
Total dollar amount billed per encounter extracted from electronic health record
Secondary Outcomes
- Body weight(Change in body weight from baseline to 36-months)
- Waist circumference(Change in waist circumference from baseline to 36-months)
- Resting heart rate(Change in resting heart rate from baseline to 36-months)
- Decisional balance(Change in decisional balance from baseline to 36-months)
- Self-regulation of physical activity - goals(Change in self-regulation of physical activity goals from baseline to 36-months)
- Coping self-efficacy(Change in coping self-efficacy from baseline to 36-months)
- Fat mass(Change in fat mass from baseline to 36-months)
- Systolic blood pressure(Change in systolic blood pressure from baseline to 36-months)
- Total cholesterol(Change in total cholesterol from baseline to 36-months)
- HDL cholesterol(Change in HDL cholesterol from baseline to 36-months)
- Visceral fat(Change in visceral fat from baseline to 36-months)
- Skeletal muscle mass(Change in skeletal muscle mass from baseline to 36-months)
- Diastolic blood pressure(Change in diastolic blood pressure from baseline to 36-months)
- Triglycerides(Change in triglycerides from baseline to 36-months)
- Readiness to change, stage of change(Change in stage of change from baseline to 36-months)
- Readiness to change, processes of change(Change in processes of change from baseline to 36-months)
- Self-efficacy for overcoming barriers to physical activity and healthy eating(Change in barrier self-efficacy from baseline to 36-months)
- Hemoglobin A1c (point of care)(Change in HbA1c from baseline to 36-months)
- Self-efficacy for weight loss and maintenance(Change in self-efficacy from baseline to 36-months)
- Self-regulation of eating behaviors(Change in self-regulation of eating behaviors from baseline to 36-months)
- Self-regulation of physical activity - planning(Change in self-regulation of physical activity planning from baseline to 36-months)
- Social support from family - eating(Change in social support from baseline to 36-months)
- Social support from friend - physical activity(Change in social support from baseline to 36-months)
- Outcome expectancies(Change in outcome expectancies from baseline to 36-months)
- Social support from friends - eating(Change in social support from baseline to 36-months)
- Social support from family - physical activity(Change in social support from baseline to 36-months)