Evaluating the Implementation of the Diabetes Prevention Program in an Integrated Health System

June 29, 2022 updated by: Kaiser Permanente
In preparation for the roll out of the Medicare Diabetes Prevention Program (DPP) in 2018, Kaiser Permanente Northwest (KPNW), a large, integrated health care system, plans to pilot the implementation of DPP starting in April 2017. Patients 19-75 years old at high risk for diabetes will be offered DPP online or DPP in-person. A pragmatic, rigorous, quantitative and qualitative evaluation will be conducted to compare patients enrolled in DPP (either online or in-person) to those not enrolled to better inform future implementation efforts of DPP within and outside of KPNW. This study is a natural experiment project.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of prediabetes and obesity among U.S. adults age 40 and older is significant, with over 30% having prediabetes and over 40% having obesity.[1,2] Prediabetes and obesity increase the risk for diabetes, cardiovascular disease, and poor quality of life, and are responsible for substantial healthcare costs.[3] In response to the multi-level burden of prediabetes and obesity, there have been several efforts to prevent diabetes at the population level and reduce healthcare costs,[4,5] including national implementation and reimbursement of the successful Diabetes Prevention Program (DPP).

Beginning in April 2018, the Centers for Medicare & Medicaid Services (CMS) made a landmark decision to reimburse clinical and non-clinical settings for providing DPP to Medicare beneficiaries (i.e., Medicare DPP); this coverage is currently for in-person DPP only and not digital DPP.[6,7] CMS's decision to cover DPP among older adults with prediabetes further catapulted efforts within healthcare organizations to address the increasing number of individuals with diabetes receiving care in their facilities. However, few studies have examined the sustainability of providing DPP based on maintenance of the effect (i.e., long-term change in weight and HbA1c), healthcare costs, participant experience, and organizational support. In addition, attracting individuals to DPP and similar lifestyle change interventions remains a significant challenge and identifying useful approaches is important.[8-11] Lastly, whereas the effectiveness of in-person DPP is well-established, prior studies evaluating the effect of digital DPP identified positive outcomes but had significant methodological limitations, such as a single arm pre- / post-test design and participant-reported outcomes.[12,13-19]

In 2017 Kaiser Permanente Northwest (KPNW), a large, integrated health system serving Oregon and southwest Washington, began piloting both digital and in-person versions of DPP for its adult health plan members with prediabetes and obesity. The purpose of this mixed-methods, natural experiment is to evaluate this large health system initiative by assessing the effects of both digital and in-person DPP on change in weight and HbA1c, health behaviors, and psychosocial factors. Also, sustainability based on cost-effectiveness and patient and healthcare stakeholder perspectives will be examined.

KPNW patients eligible to participate in DPP (digital or in-person) will be identified and recruited using the electronic health record (EHR). Both the digital and in-person (group-based) DPP programs will be delivered over 12 months. Demographic and clinical data to be included in analyses will also be extracted from the EHR. Behavioral and psychosocial questionnaires will be administered to DPP enrollees and non-enrollees online using REDCap. Semi-structured qualitative interviews will be conducted with a subset of DPP enrollees and non-enrollees to understand reasons for enrollment and likes/dislikes about the program. Healthcare system providers and stakeholders will also be interviewed to capture factors related to sustainability of offering DPP within the health system.

For the primary analysis, investigators plan to model 12- and 24-month weight and HbA1c trajectories using a linear mixed effects model using time since baseline as the time axis. Because randomization is not feasible in this real-world implementation of DPP, propensity score adjustment will be used to control for potential confounding. Furthermore, investigators will conduct an economic evaluation over the 12-month follow-up period for both the digital and in-person DPP cohorts as well as over the 24-month period for the digital DPP cohort from the perspective of the health plan, following best practices,[20] and guided by previous economic analyses of DPP interventions.[21-26]

The mixed-methods, natural experiment design investigators will use to evaluate KPNW's implementation of digital and in-person DPP will build on existing evidence related to DPP effectiveness across the two delivery modes on change in weight and HbA1c over time. In addition, the cost-effectiveness analysis will determine the impact of digital and in-person DPP on return on investment for healthcare systems and sustainability of the program. Findings from our evaluation will therefore inform best practices for implementing and sustaining DPP within large healthcare systems.

Study Type

Observational

Enrollment (Actual)

8198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

KPNW adult members with prediabetes and obesity.

Description

Inclusion Criteria:

  1. Age 19-75
  2. BMI ≥ 30; and
  3. HbA1c 5.7-6.4%.

Exclusion Criteria:

1) Diagnosis of diabetes prior to the study's recruitment efforts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Digital DPP enrolled
The DPP online program is a CDC-certified translation of the DPP lifestyle intervention delivered in an online small group format of 10-15 participants.
Behavioral: Digital DPP
The online DPP program is 12 months in duration with 16 core sessions delivered over 16-26 weeks and 6 maintenance sessions delivered over 6 months.
In-person DPP enrolled
In-person DPP participants will attend group sessions of ~20 participants in size at KPNW clinics. The group facilitator will use the CDC National DPP curriculum,
Behavioral: In-person DPP
The in-person DPP program is 12 months and consists of weekly sessions for the first 6 months and monthly sessions for the remaining 6 months.
DPP not enrolled (usual care)
Access to usual care services without restrictions.
Other: DPP not enrolled
Access to usual care services without restrictions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline through 12 months
Weight obtained from the electronic health record
Baseline through 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline through 12 months
HbA1c obtained from the electronic health record
Baseline through 12 months
Cost-effectiveness
Time Frame: Baseline through 12 months; and Baseline through 24 months (for digital DPP comparison to usual care only).
Cost data will include: 1) medical care; and 2) the cost of intervention delivery, obtained from administrative and electronic health records.
Baseline through 12 months; and Baseline through 24 months (for digital DPP comparison to usual care only).
Weight (24-month for digital DPP)
Time Frame: Baseline through 24 months
Weight obtained from the electronic health record (for digital DPP comparison to usual care only)
Baseline through 24 months
HbA1c (24-month for digital DPP)
Time Frame: Basaeline through 24 months
HbA1c obtained from the electronic health record (for digital DPP comparison to usual care only)
Basaeline through 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary Intake
Time Frame: Baseline, 6 month follow-up, and 12 month follow-up
Starting the Conversation tool will be used to measure consumption of sugar sweetened beverages, fast food, fruits & vegetables, and fat.
Baseline, 6 month follow-up, and 12 month follow-up
Depression
Time Frame: Baseline, 6 month follow-up, and 12 month follow-up
PHQ-2 will be used to assess the frequency of depressed mood and anhedonia during the two weeks prior to the Baseline and 6 month follow-up assessment points.
Baseline, 6 month follow-up, and 12 month follow-up
Quality of Life
Time Frame: Baseline, 6 month follow-up, and 12 month follow-up
SF36 Vitality subscale will be used to assess the presence of awareness and absence of fatigue.
Baseline, 6 month follow-up, and 12 month follow-up
Stress
Time Frame: Baseline, 6 month follow-up, and 12 month follow-up
Perceived Stress Scale will be used to assess perceived global stress over the past month.
Baseline, 6 month follow-up, and 12 month follow-up
Social Support - Eating Habits
Time Frame: Baseline, 6 month follow-up, and 12 month follow-up
Social Support and Eating Habits Survey will be used to assess perceived social support in this domain from family and friends.
Baseline, 6 month follow-up, and 12 month follow-up
Motivation for enrolling
Time Frame: Baseline
Treatment Self-Regulation Questionnaire for Entering a Weight Loss Program will be used to measure motivation for enrolling in DPP.
Baseline
PROMIS Global Health
Time Frame: Baseline, 6 month follow-up, and 12 month follow-up
Measure of health-related quality of life
Baseline, 6 month follow-up, and 12 month follow-up
Social Support - Exercise Habits
Time Frame: Baseline, 6 month follow-up, and 12 month follow-up
Social Support and Exercise Survey will be used to assess perceived social support in this domain from family and friends.
Baseline, 6 month follow-up, and 12 month follow-up
Motivation for continuing
Time Frame: 6 month follow-up
Treatment Self-Regulation Questionnaire for Continuing Program Participation will be used to measure motivation for continuing with DPP.
6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

April 15, 2021

Study Completion (Actual)

April 15, 2021

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DK115237 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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