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Completed

NCT Number: NCT03249077

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

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.

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 19-75
  • BMI ≥ 30; and
  • HbA1c 5.7-6.4%.

Exclusion criteria

  • Diagnosis of diabetes prior to the study's recruitment efforts

Treatment and study plan

Digital DPP

Behavioral

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

Behavioral

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

Other

Access to usual care services without restrictions.

Primary outcomes

  1. Weight

    Time frame: Baseline through 12 months

    Weight obtained from the electronic health record

Secondary outcomes

  1. HbA1c

    Time frame: Baseline through 12 months

    HbA1c obtained from the electronic health record

  2. 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.

  3. 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)

  4. 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)

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. PROMIS Global Health

    Time frame: Baseline, 6 month follow-up, and 12 month follow-up

    Measure of health-related quality of life

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2017
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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