PreDiabetes, Prediabetic State
Conditions
Keywords
diabetes prevention
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.
Interventions
BEHAVIORALDiabetes 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.
Sponsors
American Medical Association
Mississippi State Department of Health
University of Mississippi Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical expenditures | Medical expenditures from baseline to 6-months in DPP compared with non-DPP patients | Total dollar amount billed per encounter extracted from electronic health record |
| Medical encounters | Number of medical encounters between baseline and 6-months in DPP compared with non-DPP patients | Extracted from electronic health record |
| 2-hour plasma glucose | Change in 2-hour plasma glucose from baseline to 6-months in DPP compared with non-DPP patients | Lab values extracted from electronic health record |
| Fasting plasma glucose | Change in fasting plasma glucose from baseline to 6-months in DPP compared with non-DPP patients | Lab values extracted from electronic health record |
| Hemoglobin A1c | Change in HbA1c from baseline to 6-months in DPP compared with non-DPP patients | Lab values extracted from electronic health record |
| Type 2 diabetes mellitus diagnosis | Change diabetes diagnosis from baseline to 6-months in DPP compared with non-DPP patients | Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | Change in systolic blood pressure from baseline to 6-months | Welch Allyn blood pressure unit following the American Heart Association guidelines for adults. |
| Diastolic blood pressure | Change in diastolic blood pressure from baseline to 6-months | Welch Allyn blood pressure unit following the American Heart Association guidelines for adults. |
| Resting heart rate | Change in resting heart rate from baseline to 6-months | Welch Allyn blood pressure unit. |
| Total cholesterol | Change in total cholesterol from baseline to 6-months | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood |
| HDL cholesterol | Change in HDL cholesterol from baseline to 6-months | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood |
| Triglycerides | Change in triglycerides from baseline to 6-months | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood |
| Hemoglobin A1c (point of care) | Change in HbA1c from baseline to 6-months | A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood |
| Self-efficacy for weight loss and maintenance | Change in self-efficacy from baseline to 6-months | Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991 |
| Body weight | Change in body weight from baseline to 6-months | Total body weight measured using Seca mBCA 554 |
| Fat mass | Change in fat mass from baseline to 6-months | Total body fat mass measured using Seca mBCA 554; bioimpedance analysis |
| Visceral fat | Change in visceral fat from baseline to 6-months | Visceral fat measured using Seca mBCA 554; bioimpedance analysis |
| Skeletal muscle mass | Change in skeletal muscle mass from baseline to 6-months | Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis |
| Waist circumference | Change in waist circumference from baseline to 6-months | Measures using Seca 203 circumference measuring tape |
| Self-regulation of physical activity - planning | Change in self-regulation of physical activity planning from baseline to 6-months | Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002 |
| Social support from friends - eating | Change in social support from baseline to 6-months | Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 |
| Social support from family - eating | Change in social support from baseline to 6-months | Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 |
| Social support from friend - physical activity | Change in social support from baseline to 6-months | Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 |
| Social support from family - physical activity | Change in social support from baseline to 6-months | Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 |
| Outcome expectancies | Change in outcome expectancies from baseline to 6-months | Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018 |
| Coping self-efficacy | Change in coping self-efficacy from baseline to 6-months | Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018 |
| Readiness to change, stage of change | Change in stage of change from baseline to 6-months | Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009 |
| Readiness to change, processes of change | Change in processes of change from baseline to 6-months | Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011 |
| Decisional balance | Change in decisional balance from baseline to 6-months | Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988 |
| Self-efficacy for overcoming barriers to physical activity and healthy eating | Change in barrier self-efficacy from baseline to 6-months | Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018 |
| Self-regulation of eating behaviors | Change in self-regulation of eating behaviors from baseline to 6-months | Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score \<2.8, 2.8 - 3.6, \>3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016 |
| Self-regulation of physical activity - goals | Change in self-regulation of physical activity goals from baseline to 6-months | Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Eligible DPP patients (reach) | Baseline to 3-months | Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record |
| Patients eligible for DPP (reach) | Baseline to 36-months | Total number of patients in the ambulatory setting eligible for DPP; electronic health record |
| Implementation | Continuous processual evaluation | Qualitative assessment of implementation processes |
| Referring providers (adoption) | Baseline to 3-months | Total number of providers referring patients to the DPP; electronic health record |
| Referring clinical sites (adoption) | Baseline to 3-months | Total number of clinical sites referring patients to the DPP, electronic health record |
| Patients enrolled in DPP (reach) | Baseline to 3-months | Total number of patients in the ambulatory setting enrolled in DPP; electronic health record |
| Patients referred to DPP (reach) | Baseline to 3-months | Total number of patients in the ambulatory setting referred to DPP; electronic health record |
Countries
United States
Outcome results
None listed