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

NCT ID: NCT04822480

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2024-12-31

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.

Conditions

PreDiabetes; Prediabetic State

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

DPP Patients

UMMC Patients with prediabetes or risk for diabetes based on risk parameters referred to and enrolled in the DPP.

Diabetes Prevention Program (DPP)

Intervention Type: BEHAVIORAL

Individuals with prediabetes can mitigate the risks and costs of diabetes by taking preventative action, such as participation in a National Diabetes Prevention Program (DPP). The DPP began as a multisite randomized controlled trial demonstrating the effectiveness and cost-benefit of a 12-month intensive lifestyle intervention over pharmaceutical treatment for preventing or delaying diabetes among prediabetic participants. In 2010, Congress authorized the Centers for Disease Control and Prevention to lead the dissemination of the DPP as a targeted approach (high risk populations) and population-based strategy to reduce the incidence of diabetes and diabetes-related healthcare costs. The goal is to achieve modest weight loss (7%) by developing and implementing behavior change skills resulting in lifestyle modifications such as physical activity (150 minutes per week) and dietary and nutritional practices.

Non-DPP Patients

Control matched UMMC patients with prediabetes or risk for diabetes based on risk parameters not enrolled in the DPP.

No interventions assigned to this group

Interventions

Diabetes Prevention Program (DPP)

Individuals with prediabetes can mitigate the risks and costs of diabetes by taking preventative action, such as participation in a National Diabetes Prevention Program (DPP). The DPP began as a multisite randomized controlled trial demonstrating the effectiveness and cost-benefit of a 12-month intensive lifestyle intervention over pharmaceutical treatment for preventing or delaying diabetes among prediabetic participants. In 2010, Congress authorized the Centers for Disease Control and Prevention to lead the dissemination of the DPP as a targeted approach (high risk populations) and population-based strategy to reduce the incidence of diabetes and diabetes-related healthcare costs. The goal is to achieve modest weight loss (7%) by developing and implementing behavior change skills resulting in lifestyle modifications such as physical activity (150 minutes per week) and dietary and nutritional practices.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Medical Association

OTHER

Sponsor Role: collaborator

Mississippi State Department of Health

OTHER_GOV

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Abigail Gamble

Assistant Professor of Preventive Medicine and Population Health Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abigail Gamble, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Tamkeen Khan, PhD

Role: PRINCIPAL_INVESTIGATOR

American Medical Association

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Countries

United States

References

Gamble A, Khan T, Hughes A, Guo Y, Vasaitis S, Bidwell J, Christman B. Telehealth Diabetes Prevention Program for Adults With Prediabetes in an Academic Medical Center Setting: Protocol for a Hybrid Type III Trial. JMIR Res Protoc. 2023 Nov 13;12:e50183. doi: 10.2196/50183.

Reference Type: DERIVED

PMID: 37955955 (View on PubMed)

Other Identifiers

2020V0327

Identifier Type: -

Identifier Source: org_study_id