More Individualized Care: Assessment and Recovery Through Engagement (NCT05122676) | Clinical Trial Compass
CompletedNot Applicable
More Individualized Care: Assessment and Recovery Through Engagement
United States805 participantsStarted 2021-11-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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;
Exclusion criteria
✕. 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:
What they're measuring
1
Days of buprenorphine medication treatment for opioid use disorder (OUD)