Measurement-based Care to Support Delivery of Buprenorphine-naloxone Treatment in Outpatient Addiction Clinics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Reach
研究概览
简要总结
People receiving buprenorphine-naloxone (bup-nx) for opioid use disorder often face changes in cravings, withdrawal, and return to use risk between clinic visits, but their care team may not know about these changes until the person misses an appointment or returns to drug use. Measurement-based care (MBC) uses brief, repeated check-ins from patients to make these between-visit changes visible. This study tests "Bup-MBC," a strategy that sends patients short questionnaires through their patient portal or by text before and between visits, gives them immediate supportive feedback, shares summary information with their prescriber in the electronic health record, and offers an option to request earlier contact if concerns arise. The study will include providers and patients at outpatient addiction clinics at Vanderbilt University Medical Center, randomly assigned to either receive Bup-MBC or usual care, and followed for 6 months. The main goal is to determine whether Bup-MBC can be practically delivered in routine addiction clinics and whether patients and providers use it.
详细描述
Bup-MBC is an electronic health record-embedded implementation strategy designed to support evidence-based buprenorphine-naloxone (bup-nx) treatment for opioid use disorder (OUD) by integrating patient-reported outcome measures (PROMs) and related indicators into routine outpatient addiction care. The strategy comprises four components: (1) structured between-visit PROMs assessing withdrawal, craving, medication adherence, medication side effects, opioid overdose risk, other substance use, global treatment improvement, and recovery community connection; (2) automated non-punitive patient feedback immediately following PROM completion; (3) EHR-embedded longitudinal clinician-facing summaries with non-directive decision-support prompts; and (4) an opt-in between-visit outreach pathway with predefined safety overrides for critical disclosures.
This pragmatic pilot hybrid type III effectiveness-implementation trial will enroll adults with an active bup-nx prescription at outpatient addiction clinics at Vanderbilt University Medical Center (Bridge Clinic, Vanderbilt Recovery Clinic, and Firefly Clinics). Providers will be individually randomized 1:1 to Bup-MBC or usual care. The 6-month observation period will evaluate implementation outcomes using the RE-AIM framework (Reach, Adoption, Implementation) as primary outcomes, and exploratory clinical outcomes including medication possession ratio, visit adherence, treatment retention, urgent refill requests, emergency department utilization, and urine drug screen results. Qualitative interviews with clinicians and clinic leadership will assess acceptability, feasibility, and sustainability.
Bup-MBC and this study were developed following a qualitative needs assessment, systematic review of single-item PROMs for substance use treatment, and theory-guided intervention design using the Theoretical Domains Framework and COM-B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •(1) Adult (age ≥18); (2) Active bup-nx prescription under a participating prescriber at one of the five VUMC addiction clinics (Bridge Clinic, Vanderbilt Recovery Clinic, or Firefly Clinic); (3) Enrolled in and active in the respective clinic
排除标准
- 未提供
研究组 & 干预措施
Bup-MBC
Patients seen by a provider randomized to Bup-MBC receive automated between-visit PROMs via patient portal or secure text, immediate tailored non-punitive feedback after completion, eligibility for clinician-facing EHR summaries with non-directive prompts, and an opt-in option to request earlier contact between visits, with predefined safety overrides for critical disclosures.
干预措施: Bup-MBC (Behavioral)
Usual care
Patients seen by a provider randomized to usual care continue to receive standard buprenorphine-naloxone treatment and routine clinic services without PROM invitations or Bup-MBC components.
结局指标
主要结局
Reach
时间窗: From enrollment to the end of the study period (12 months) or 6 months, whichever is shorter
Proportion of eligible patients randomized to Bup-MBC who complete ≥1 questionnaire; monthly completion rates with 95% confidence intervals
次要结局
未报告次要终点
研究者
Thomas Reese
Assistant Professor
Vanderbilt University Medical Center