More Individualized Care: Assessment and Recovery Through Engagement

Completed · Not applicable

Conditions studied: Depression, Anxiety, Opioid-Related Disorders, Pain, Chronic

In brief

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.

Key facts

Study ID

NCT05122676

Run by

Kaiser Permanente

People needed

805

Starts

2021-11-10

Expected to finish

2026-02-28

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Indiana University Health — Indianapolis, Indiana, United States
• Kaiser Permanente Washington Health Research Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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