More Individualized Care: Assessment and Recovery Through Engagement
MI-CARE
Patient-centered Team-based Primary Care to Treat Opioid Use Disorder, Depression, and Other Conditions
3 other identifiers
interventional
805
1 country
2
Brief Summary
The MI-CARE trial tests 12 months of telephone-based nurse care management for patients with depressive symptoms who take or have taken opioids at some time. The study tests whether offering nurse support to the patient and their primary care team that addresses these things and related issues can improve patients' health and well-being. Eligible subjects are identified automatically using health system data and randomly assigned 50:50 to either a no-contact usual care arm or to the arm offered the MI-CARE program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Nov 2021
Longer than P75 for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2021
CompletedStudy Start
First participant enrolled
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedMarch 30, 2026
March 1, 2026
4.3 years
October 29, 2021
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days of buprenorphine medication treatment for opioid use disorder (OUD)
A continuous measure of days of OUD treatment with buprenorphine in the 365 days after randomization from secondary electronic data sources.
days 1-365 after randomization
Secondary Outcomes (1)
Change in depressive symptoms
3-13 months after randomization
Other Outcomes (3)
Buprenorphine treatment or improved depressive symptoms
1 day - 13 months after randomization
Major acute adverse health events
12 months after randomization
Serious opioid related event
12 months after randomization
Study Arms (2)
MI-CARE program
EXPERIMENTALThose automatically identified as eligible and randomized to the MI-CARE arm are outreached by a study nurse care manager and offered the 12-month long virtual Collaborative Care program by telephone or video visits. Individuals are free to accept or decline the offer (e.g., stop/restart, not accept right away) during the 12 months after their randomization date.
Usual care
NO INTERVENTIONThose identified as eligible and randomized to the usual care arm have no contact with the study. All outcome data for both study arms are collected from secondary, electronic sources.
Interventions
This study evaluates whether offering nurse collaborative care management for 12 months by telephone or video can improve depression-related symptoms, increase access to evidence-based medication treatment for opioid use problems, as well as decreasing adverse health events. Participants randomized to the nurse support arm can work with the nurse at no cost for up to 12 months via phone or video visits. The nurse asks questions about stress, mood, worry, pain, sleep, and medication and substance use; participants choose what to focus on. The nurse meets weekly with clinical consultants who may recommend treatment options, tailored to the patient. The participant and their regular provider(s) can discuss the options and decide which to try. The nurse and primary care provider can then help the patient access selected options. The nurse can also offer behavioral activation to help build skills to increase day-to-day positive adaptive experiences and support broader treatment gains.
Eligibility Criteria
You may qualify if:
- Eligible patients must meet all 4 criteria:
- ≥1 in person or virtual encounter in a primary care setting in the 365 days prior to the data extraction date (pull date);
- Age ≥18 years at the pull date;
- ≥1 PHQ-9 depression screening score of ≥10 within the 7 days prior to the pull date.
- Evidence of potential OUD in the 365 days prior to and including the date of the qualifying PHQ-9 score. Any 1 of the following qualifies as evidence of potential OUD:
- ≥1 active OUD ICD-10 diagnosis code in any setting except labs;
- ≥1 prescription (orders or dispensed) for buprenorphine (oral formulations indicated for OUD, extended release injectable, and implant);
- ≥1 procedure code for buprenorphine (oral formulations indicated for OUD, extended release injectable, and implant);
- ≥1 ICD-10 codes for opioid overdose;
- ≥1 OUD ICD-10 code, including remission, and prescription (orders or dispensed) or procedure code for injectable naltrexone.
You may not qualify if:
- Patients are ineligible who meet any of the criteria below:
- The only indication of OUD or only PHQ available to determine eligibility came from data protected under 42 CFR Part 2;
- The patient has already been randomized to the trial or was outreached in the pilot study (including outreach to the primary care provider only);
- English interpreter required (per health system records).
- Any one of the following conditions in the 2 years prior to and including the date of the qualifying PHQ:
- Alzheimer's disease or dementia diagnosis, or medication to treat Alzheimer's or dementia.
- Severe cognitive limitations.
- Current active treatment for cancer with chemotherapy or radiation therapy in the past 3 months (not including non-melanoma skin cancers).
- Previously requested to not participate in research studies at the health system;
- Documentation of hospice care in the 2 years prior to and including the date of the qualifying PHQ score;
- Patient is actively being outreached for (or is participating in) depression care management (Kaiser Permanente Washington only)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Mental Health (NIMH)collaborator
- Boston Medical Centercollaborator
- University of New Mexicocollaborator
- University of Washingtoncollaborator
- Purdue Universitycollaborator
- Montana State Universitycollaborator
- Kaiser Permanentelead
- Indiana University Healthcollaborator
Study Sites (2)
Indiana University Health
Indianapolis, Indiana, 46202, United States
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101, United States
Related Publications (1)
DeBar LL, Bushey MA, Kroenke K, Bobb JF, Schoenbaum M, Thompson EE, Justice M, Zatzick D, Hamilton LK, McMullen CK, Hallgren KA, Benes LL, Forman DP, Caldeiro RM, Brown RP, Campbell NL, Anderson ML, Son S, Haggstrom DA, Whiteside L, Schleyer TKL, Bradley KA. A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial. Contemp Clin Trials. 2023 Apr;127:107124. doi: 10.1016/j.cct.2023.107124. Epub 2023 Feb 18.
PMID: 36804450DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn DeBar, PhD
Kaiser Permanente
- PRINCIPAL INVESTIGATOR
Katharine A Bradley, MD, MPH
Kaiser Permanente
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Usual care arm participants are not informed of the study; their secondary data are used for study analyses. Investigators are masked to all individuals in usual care arm and to the safety monitoring reports shared with the Data and Safety Monitoring Board (DSMB); study arms are masked in safety monitoring reports provided to the Data Safety and Monitoring Board unless the DSMB requests that they be unmasked; and statistical analysts conducting main outcomes are blinded to arm by masking and omission of any data in main analytic datasets that would indicate intervention arm (e.g., any measures related to nurse care managers).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2021
First Posted
November 17, 2021
Study Start
November 10, 2021
Primary Completion
February 28, 2026
Study Completion
February 28, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Access Criteria
- Although our trial had planned to publicly share data with the NIMH data archive (NDA), they determined on February 24, 2022 that they would remove our grant from NDA data sharing because the subjects in this trial do not have signed consent forms.
The MI-CARE trial will involve analysis of a large amount of detailed proprietary secondary electronic health plan data from the Kaiser Permanente Washington and Indiana University Health systems, and state-wide datasets, e.g., prescription monitoring programs (PMPs). We will seek to obtain data use agreements that allow us to share all de-identified data. However, if that is not possible, we will share those de-identified data for which we do have permission to share.