More Individualized Care: Assessment and Recovery Through Engagement

Not Applicable

Active, not recruiting

• Conditions: Opioid-Related Disorders; Depression; Pain, Chronic; Anxiety

• Registration Number: NCT05122676
• Lead Sponsor: Kaiser Permanente

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-29
• Study Start: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 804

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Kaiser Permanente Washington Health Research Institute; 🇺🇸 Seattle, Washington, United States

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States