N/A
N=294
INTEGRATE-D: A Pilot Test to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes
Type II Diabetes · Primary Health Care · Behavioral Health
Bottom Line
View on ClinicalTrials.gov: NCT04461405 ↗Enrolled (actual)
294
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Acceptability of Intervention — 0.60 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- INTEGRATE-D (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of Intervention |
0.60 | — |
| PRIMARY Feasibility of the Intervention |
0.50 | — |
| PRIMARY Appropriateness of Intervention |
0.79 | — |
| SECONDARY Change in Hemoglobin A1c |
-0.04; -0.08 | — |
| SECONDARY Change in Patient Health Questionnaire-9 (PHQ-9) |
-1.25; 2.44 | — |
Summary
In 2016, the American Diabetes Association (ADA) published its first-ever recommendations for integrating medical and psychosocial care for patients with Type II Diabetes Mellitus (DMII) and common mental and behavioral health (MH/BH) problems. In the United States, 30 million people live with DMII, and the majority receive care in primary care settings. By implementing the ADA recommendations, primary care practices will help patients better manage their MH/BH needs, meet recommended goals for DMII management, and reduce the risk of adverse outcomes. Making these recommendations a routine part of practice is a major change, and it is critical to understand how best to implement the ADA recommendations and test its effectiveness in the real world. The pilot study builds on a series of prior studies to refine and pilot test a package of implementation strategies - called INTEGRATE-D - to support practices in implementing the ADA recommendations for integrated DMII care. INTEGRATE-D combines the following evidence-based implementation strategies: (1) electronic health record (EHR)-based support - to help align EHR use with ADA recommendations and enable screening for depression, anxiety, diabetes distress, cognitive impairment, and self-management, and support identifying and tracking progress on patient treatments and goals; (2) Audit and feedback - which involves assisting practices in accessing clinically relevant, actionable data reports to inform measurement and identification of care gaps in DMII and behavioral health care; (3) Skill-building resources - including training on ADA-recommended care; and (4) Facilitation - to help implement the above strategies and tailor the intervention so that practice work on the subset of areas where practices are ready to change to align care with ADA recommendations. The study aims are Aim 1: Refine the INTEGRATE-D intervention by incorporating the preferences of stakeholders. In partnership with patients, primary care key stakeholders and experts, compile and refine the package of implementation strategies in the INTEGRATE-D intervention. Aim 2: Demonstrate feasibility, acceptability, and estimate cost. Conduct a mixed-method, pre-post pilot comparing two practices that receive the INTEGRATE-D intervention to two control practices that receive training materials only.
Eligibility Criteria
Inclusion Criteria
In order for patients to become eligible, their primary care practice must meet the following inclusion criteria:
- Primary care practices are affiliated with the Oregon Rural Practice-Based Network (ORPRN), at time of recruitment.
- Primary care practices must be located in Oregon.
- Primary care practices have more than 100 adult patients aged 18 years or older with an electronic health record-based diagnosis of Type II Diabetes Melitus (DMII).
Once the criteria for a primary care practice is satisfied, the inclusion criteria for DMII patients includes the following:
- Patients are 18 years of age or older.
- Patients have an electronic health record-based diagnosis of DMII.
- Patients were seen by an ORPRN practice at least once in the 15 months prior to the start of intervention and once during the intervention.
Exclusion Criteria
Primary care practices that do not meet the inclusion criteria established are not eligible for the pilot study.
Data sourced from ClinicalTrials.gov (NCT04461405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.