Patient-centered Team-based Primary Care to Treat Opioid Use Disorder, Depression, and Other Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 805
- 试验地点
- 2
- 主要终点
- Days of buprenorphine medication treatment for opioid use disorder (OUD)
研究概览
简要总结
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.
详细描述
The MI-CARE trial is a randomized encouragement trial that will test whether offering a primary care-based collaborative care (CC) model can increase opioid use disorder (OUD) treatment and improve depression outcomes among patients with:
- recent electronic health record (EHR) documentation of depressive symptoms, and
- evidence of OUD documented in the prior year.
The study objective is to evaluate the effectiveness of offering eligible primary care patients the MI-CARE CC program for up to 12 months when compared to usual primary care. Among all eligible primary care patients, MI-CARE and usual primary care will be compared to assess the following outcomes:
- Aim 1: Days of OUD medication treatment (buprenorphine)
- Aim 2: Improvement of depression symptoms.
- Aim 3 (intervention arm only): Examining a) implementation using mixed-methods formative evaluation including reach, adoption, and implementation fidelity, and b) nurse care manager time needed to support the MICARE intervention.
The MI-CARE CC intervention is offered by a nurse care manager (NCM) and delivered by telephone (or video) visits to consenting patients. The intervention is designed to support "whole health" by engaging patients in medication treatment for OUD and depression, reducing depressive symptoms, and addressing common comorbid conditions that complicate OUD and depression (e.g., anxiety, pain, sleep, and other mental health and substance use disorders).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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, or medication to treat Alzheimer's or dementia.
- •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)
研究组 & 干预措施
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.
干预措施: More Individualized Care: Assessment and Recovery through Engagement (MI-CARE) (Behavioral)
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.
结局指标
主要结局
Days of buprenorphine medication treatment for opioid use disorder (OUD)
时间窗: 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.
次要结局
- Change in depressive symptoms(3-13 months after randomization)