INTEGRATE-D: A Pilot Test to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes
NCT04461405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 294
Last updated 2025-02-07
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
Interventions
- BEHAVIORAL
-
INTEGRATE-D
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.
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
Oregon Health and Science University
lead OTHER
Principal Investigators
-
Deborah Cohen, PhD · Oregon Health and Science University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-03-01
- Primary Completion
- 2022-07-01
- Completion
- 2022-07-01
Countries
- United States
Study Locations
More Related Trials
-
Remotely Delivered Mindfulness-Based Diabetes Education
NCT06312553 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Diabetes Support Project: Couples Intervention
NCT01017523 ·Status: COMPLETED ·Phase: PHASE3
-
Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes
NCT05925556 ·Status: COMPLETED ·Phase: NA
-
Integrated Behavioral Healthcare for Youth With Type 1 Diabetes
NCT05915975 ·Status: COMPLETED ·Phase: NA
-
Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
NCT06405373 ·Status: RECRUITING ·Phase: NA
-
Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study
NCT01486290 ·Status: COMPLETED ·Phase: NA
-
mHealth for Diabetes Adherence Support
NCT02990299 ·Status: COMPLETED ·Phase: NA
-
A Pilot Intervention Study of Health Coaching to Promote Diabetes Self-Care in the Community
NCT01695278 ·Status: COMPLETED ·Phase: PHASE3
-
Minimal Psychological Intervention in Diabetes Patients
NCT02473081 ·Status: COMPLETED ·Phase: NA
-
Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes
NCT06459596 ·Status: COMPLETED ·Phase: NA
-
Improving Medication Adherence in Comorbid Conditions
NCT00072891 ·Status: COMPLETED ·Phase: NA
-
The Effect of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes
NCT03083795 ·Status: UNKNOWN ·Phase: NA
-
Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c
NCT03363100 ·Status: COMPLETED ·Phase: NA
-
Translating Telephonic Diabetes Self-management Support to Primary Care Practice
NCT02137720 ·Status: COMPLETED ·Phase: NA
-
Boosting Emotions & Happiness in Outpatients Living With Diabetes: Phase I
NCT03001999 ·Status: COMPLETED ·Phase: NA
-
Improving Diabetes Outcomes: a Couples Intervention
NCT00250731 ·Status: COMPLETED ·Phase: PHASE1
-
Multi-arm Intervention Diabetes Adherence Study
NCT00754741 ·Status: COMPLETED ·Phase: PHASE3
-
Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)
NCT00745342 ·Status: COMPLETED ·Phase: NA
-
Type 1 Diabetes and Diabetes Distress
NCT06936280 ·Status: RECRUITING ·Phase: NA
-
Breaking Down Barriers to Diabetes Self-Care
NCT00142922 ·Status: COMPLETED ·Phase: NA
-
Identification and Treatment of Diabetes In Solid Organ Transplant Recipients
NCT02605200 ·Status: COMPLETED ·Phase: NA
-
Taking Action: a Care for Type 2 Diabetes Intervention for Couples
NCT04014582 ·Status: COMPLETED ·Phase: NA
-
Diabetes Homeless Medication Support
NCT05258630 ·Status: COMPLETED ·Phase: PHASE2
-
Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications
NCT05463705 ·Status: COMPLETED ·Phase: NA
-
Pilot Trial of the Nutrition-Supported Diabetes Education Program
NCT05067452 ·Status: COMPLETED ·Phase: NA