INTEGRATE-D: A Pilot Test to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes

NCT04461405 | Completed Results

• 2 other identifiers: 207835R34DK124146
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type II Diabetes; Primary Health Care; Behavioral Health

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention

  A post-intervention four-item survey that evaluates the extent to which the intervention meets practice members' approval, is appealing and is liked and welcomed. The items were assessed on a Likert scale, ranging from -2 to 2 (i.e., completely disagree to completely agree, with 0 indicating neutrality). Composite scores were created by averaging scores for the four individual items. The scale range is from -2 (minimum) to +2 (maximum), where higher values represent a better outcome (more approval).

  At 15 months, post-intervention

• Feasibility of the Intervention

  A post-intervention four-item survey that evaluates the extent to which the intervention is implementable, seems possible, seems doable, and seems easy to use. The items were assessed on a Likert scale, ranging from -2 to 2 (i.e., completely disagree to completely agree, with 0 indicating neutrality). Composite scores were created by averaging scores for the four individual items. The scale range is from -2 (minimum) to +2 (maximum), where higher values represent a better outcome (more approval).

  At 15 months, post-intervention

• Appropriateness of Intervention

  A post-intervention four-item survey that evaluates the extent to which the intervention meets practice members' approval, is appealing and is liked and welcomed. The items were assessed on a Likert scale, ranging from -2 to 2 (i.e., completely disagree to completely agree, with 0 indicating neutrality). Composite scores were created by averaging scores for the four individual items. The scale range is from -2 (minimum) to +2 (maximum), where higher values represent a better outcome (more approval).

  At 15 months, post-intervention

Secondary Outcomes (2)

• Change in Hemoglobin A1c

  Baseline (pre-intervention) and 15-months (post-intervention).

• Change in Patient Health Questionnaire-9 (PHQ-9)

  Baseline (pre-intervention) and 15-months (post-intervention).

Study Arms (2)

Intervention Arm

EXPERIMENTAL

INTEGRATE-D is a step-by-step blueprint that will assist practices with employing American Diabetes Association recommendations for integrating medical and psychosocial care. INTEGRATE-D consists of a set of implementation strategies that enable clinical teams to put evidence-based care in place. The intervention consists of training and education; audit and feedback materials; a facilitation implementation protocol; and health information technology support materials.

Behavioral: INTEGRATE-D

Control Arm

NO INTERVENTION

Usual care

Interventions

INTEGRATE-D BEHAVIORAL

INTEGRATE-D provides primary care practices with evidence-based training and support which includes: (1) Electronic health record (EHR)-based support-to help align EHR use with ADA recommendations and enable screening for depression, anxiety, DM 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 the practice changes needed to align care with ADA recommendations.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Deborah Cohen
• Organization: Oregon Health & Science University

cohendj@ohsu.edu

503-781-8795

Study Officials

• Deborah Cohen, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Research

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 8, 2020
• Study Start: March 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 7, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)