search
Back to results

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

Primary Purpose

Depression, Anxiety, Opioid-Related Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Indiana University Health
  • Kaiser Permanente Washington Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MI-CARE program

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Days of buprenorphine medication treatment for opioid use disorder (OUD)
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
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.

Full Information

First Posted
October 29, 2021
Last Updated
September 1, 2023
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
search

1. Study Identification

Unique Protocol Identification Number
NCT05122676
Brief Title
More Individualized Care: Assessment and Recovery Through Engagement
Acronym
MI-CARE
Official Title
Patient-centered Team-based Primary Care to Treat Opioid Use Disorder, Depression, and Other Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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).
Allocation
Randomized
Enrollment
804 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MI-CARE program
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days of buprenorphine medication treatment for opioid use disorder (OUD)
Description
A continuous measure of days of OUD treatment with buprenorphine in the 365 days after randomization from secondary electronic data sources.
Time Frame
days 1-365 after randomization
Secondary Outcome Measure Information:
Title
Change in depressive symptoms
Description
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.
Time Frame
3-13 months after randomization
Other Pre-specified Outcome Measures:
Title
Buprenorphine treatment or improved depressive symptoms
Description
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).
Time Frame
1 day - 13 months after randomization
Title
Major acute adverse health events
Description
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).
Time Frame
12 months after randomization
Title
Serious opioid related event
Description
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.
Time Frame
12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn DeBar, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katharine A Bradley, MD, MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Kaiser Permanente Washington Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The MI-CARE trial will involve analysis of a large amount of detailed proprietary secondary electronic health plan data from the Kaiser Permanente Washington and Indiana University Health systems, and state-wide datasets, e.g., prescription monitoring programs (PMPs). We will seek to obtain data use agreements that allow us to share all de-identified data. However, if that is not possible, we will share those de-identified data for which we do have permission to share.
IPD Sharing Access Criteria
Although our trial had planned to publicly share data with the NIMH data archive (NDA), they determined on February 24, 2022 that they would remove our grant from NDA data sharing because the subjects in this trial do not have signed consent forms.

Learn more about this trial

More Individualized Care: Assessment and Recovery Through Engagement

We'll reach out to this number within 24 hrs