More Individualized Care: Assessment and Recovery Through Engagement

Depression Clinical Trial

— MI-CARE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05122676
• Other study ID #: UF1MH121949
• Secondary ID: 1UF1MH121949-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 804
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Chronic Pain
• Depression
• Opioid-Related Disorders
• Pain, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University Health	Indianapolis	Indiana
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
Kaiser Permanente	Boston Medical Center, Indiana University Health, Montana State University, National Institute of Mental Health (NIMH), Purdue University, University of New Mexico, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Buprenorphine treatment or improved depressive symptoms	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).	1 day - 13 months after randomization
Other	Major acute adverse health events	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).	12 months after randomization
Other	Serious opioid related event	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.	12 months after randomization
Primary	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.	days 1-365 after randomization
Secondary	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.	3-13 months after randomization