Clinical trial NCT05122676: More Individualized Care: Assessment and Recovery Through Engagement
Official title: Patient-centered Team-based Primary Care to Treat Opioid Use Disorder, Depression, and Other Conditions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Opioid-Related Disorders
Pain, Chronic
Keywords: Primary health care
Primary care
Primary care nursing
Evidence-based care
Depressive symptoms
Anxiety disorders and symptoms
Mental Health
Mental Health disorder
Opioid use
Opioid misuse
Opioid use disorder
Opioid dependence
Buprenorphine
Substance use disorders
Overdose
Overdose of opiate
Opioid overdose
Motivational Interviewing
Brief psychotherapy
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Indiana University Health
name: National Institute of Mental Health (NIMH)
name: Boston Medical Center
name: University of New Mexico
name: University of Washington
name: Purdue University
name: Montana State University
First posted: 2021-11-17
Enrollment: 804
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.
   2. Medication to treat Alzheimer's or dementia.

   (b) 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)

Primary outcomes:
measure: Days of buprenorphine medication treatment for opioid use disorder (OUD)
timeFrame: days 1-365 after randomization
Secondary outcomes:
measure: Change in depressive symptoms
timeFrame: 3-13 months after randomization
Other outcomes:
measure: Buprenorphine treatment or improved depressive symptoms
timeFrame: 1 day - 13 months after randomization
measure: Major acute adverse health events
timeFrame: 12 months after randomization
measure: Serious opioid related event
timeFrame: 12 months after randomization
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Lynn DeBar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Katharine A Bradley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: