More Individualized Care: Assessment and Recovery Through Engagement

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Indiana University Health

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Boston Medical Center

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Purdue University

  collaborator OTHER

• Montana State University

  collaborator OTHER

• Kaiser Permanente

  lead OTHER

Principal Investigators

• Lynn DeBar, PhD · Kaiser Permanente

• Katharine A Bradley, MD, MPH · Kaiser Permanente

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-10

Primary Completion

2026-02-28

Completion

2026-02-28

Countries

• United States

Study Locations