MI-CARE: More Individualized Care: Assessment and Recovery Through Engagement

Sponsor

Kaiser Permanente (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05122676

Collaborator

Indiana University Health (Other), National Institute of Mental Health (NIMH) (NIH), Boston Medical Center (Other), University of New Mexico (Other), University of Washington (Other), Purdue University (Other)

800

Enrollment

Locations

Arms

28.7

Anticipated Duration (Months)

400

Patients Per Site

13.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Opioid-Related Disorders Pain, Chronic	Behavioral: More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

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).

Primary Purpose:

Treatment

Official Title:

Patient-centered Team-based Primary Care to Treat Opioid Use Disorder, Depression, and Other Conditions

Actual Study Start Date :

Nov 10, 2021

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MI-CARE program Those 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.	Behavioral: More Individualized Care: Assessment and Recovery through Engagement (MI-CARE) 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.
No Intervention: Usual care Those 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.

Arm

Intervention/Treatment

Experimental: MI-CARE program

Those 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.

Behavioral: More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)

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.

No Intervention: Usual care

Those 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.

Outcome Measures

Primary Outcome Measures

Days of buprenorphine medication treatment for opioid use disorder (OUD) [days 1-365 after randomization]
A continuous measure of days of OUD treatment with buprenorphine in the 365 days after randomization from secondary electronic data sources.

Secondary Outcome Measures

Change in depressive symptoms [3-13 months after randomization]
Change in depressive symptoms from the study qualifying Patient Health Questionnaire (PHQ) score to follow-up PHQ score documented as part of routine clinical care 3-13. months later from secondary electronic data sources. The 9-item Patient Health Questionnaire (PHQ9) has a minimum score of 0 and a maximum score of 27. the 2-item Patient Health Questionnaire (PHQ2) has a minimum score of 0 and a maximum score of 6. An increasing PHQ score indicates an increase in depressive symptoms.

Other Outcome Measures

Buprenorphine treatment or improved depressive symptoms [1 day - 13 months after randomization]
Composite measure identifying whether a patient is treated with buprenorphine and/or has documentation of clinically-significant improvement in depressive symptoms from secondary electronic data sources: Treatment with buprenorphine is a binary measure of treatment with buprenorphine formulations for pain or OUD defined as > 90 days of buprenorphine during the 12-month follow up period. Clinically significant improvement in depressive symptoms is a binary measure of documented clinical response of depressive symptoms during follow-up (50% decrease in PHQ9 score or negative PHQ2 screen).
Major acute adverse health events [12 months after randomization]
A composite of any major adverse event over 12 months of follow-up, which includes: opioid overdose, other drug overdose, suicide attempt or other self-harm, hospitalizations (opioid and non-opioid), or death (from secondary electronic data sources).
Serious opioid related event [12 months after randomization]
A count of the number of serious opioid-related events over 12 months of follow up; defined as emergency department visits or hospital admissions with a primary OUD or opioid-related diagnosis or an opioid-related overdose (lethal of non-lethal), from secondary electronic data sources.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA

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.

EXCLUSION CRITERIA

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.
Medication to treat Alzheimer's or dementia.

(b) 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Health	Indianapolis	Indiana	United States	46202
2	Kaiser Permanente Washington Health Research Institute	Seattle	Washington	United States	98101