More Individualized Care: Assessment and Recovery Through Engagement
CompletedNot applicableNCT05122676
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Patient-centered Team-based Primary Care to Treat Opioid Use Disorder, Depression, and Other Conditions
- Interventions
- Behavioral: More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)
- Sponsor
- Kaiser Permanente
- Collaborators
- Indiana University Health; National Institute of Mental Health (NIMH); Boston Medical Center; University of New Mexico; University of Washington; Purdue University; Montana State University
- Start date
- 2021-11-10
- Primary completion
- 2026-02-28
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
INCLUSION CRITERIA Eligible patients must meet all 4 criteria: 1. ≥1 in person or virtual encounter in a primary care setting in the 365 days prior to the data extraction date (pull date); 2. Age ≥18 years at the pull date; 3. ≥1 PHQ-9 depression screening score of ≥10 within the 7 days prior to the pull date. 4. 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. ≥1 active OUD ICD-10 diagnosis code in any setting except labs; 2. ≥1 prescription (orders or dispensed) for buprenorphine (oral formulations indicated for OUD, extended release injectable, and implant); 3. ≥1 procedure code for buprenorphine (oral formulations indicated for OUD, extended release injectable, and implant); 4. ≥1 ICD-10 codes for opioid overdose; 5. ≥1 OUD ICD-10 code, including remission, and prescription (orders or dispensed) or procedure code for injectable naltrexone. EXCLUSION CRITERIA Patients are ineligible who meet any of the criteria below: 1. The only indication of OUD or only PHQ available to determine eligibility came from data protected under 42 CFR Part 2; 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); 3. English interpreter required (per health system records). 4. Any one of the following conditions in the 2 years prior to and including the date of the qualifying PHQ: 1. Alzheimer's disease or dementia diagnosis, or medication to treat Alzheimer's or dementia. 2. Severe cognitive limitations. 5. Current active treatment for cancer with chemotherapy or radiation therapy in the past 3 months (not including non-melanoma skin cancers). 6. Previously requested to not participate in research studies at the health system; 7. Documentation of hospice care in the 2 years prior to and including the date of the qualifying PHQ score; 8. Patient is actively being outreached for (or is participating in) depression care management (Kaiser Permanente Washington only)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05122676