Evaluating the Implementation of the Diabetes Prevention Program in an Integrated Health System
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      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.
    

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.
    

Intervention name(s): Digital DPP; In-person DPP; DPP not enrolled
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): 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.; 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.; Access to usual care services without restrictions.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        KPNW adult members with prediabetes and obesity.
      
Keywords: Prevention; Medicare