Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in reported health related quality of life (4-point scale), assessed via CDC HRQOL questionnaire
研究概览
简要总结
Performance measure can improve quality of care at the patient, provider, and systems level of care, and patient-reported outcome measures bring a needed patient-centered focus. Recovery has been difficult to measure for people with substance use disorders, and is more challenging in the context of opioid use disorders (OUD) and treatment medications. This study will examine a recovery patient-reported outcome measure to determine if patients and clinicians find it useful and acceptable in the clinical context, and if it leads to improved outcomes.
详细描述
The pilot clinical trial will test the newly developed Recovery Patient-Reported Outcome Measure ("Recovery PROM") and approach with patients and clinicians in an office-based opioid medication treatment program (known as office-based opioid treatment (OBOT), medication-assisted treatment (MAT) or medications for OUD (MOUD)), in the specific context of buprenorphine treatment.
Aims
This is a pilot study to assess the feasibility of implementing the Recovery PROM into the workflow of a clinical setting, assess its initial effectiveness, and evaluate its value to patients and clinicians. The aims are as follows:
- Work with a clinical partner to assess and refine the draft Recovery PROM, and examine feasibility and implementation (e.g., workflow, data transfer issues) related to its use in a clinical setting.
- Determine initial effectiveness of the Recovery PROM for improving patient outcomes (self-efficacy, health-related quality of life, patient-provider relationship, social determinants of health, substance use) and facilitating self-directed care and patient-centered shared decision-making.
- Evaluate and update (if needed) the Recovery PROM in terms of recovery while on OUD medication treatment, patient characteristics, and clinical workflow.
Hypotheses Although this pilot study is primarily for information gathering, and ultimately refinement of the Recovery PROM and approach, the study has two broad hypotheses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
The intervention is not blinded to patients, clinicians, or investigators.
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
- •Taking buprenorphine for OUD treatment, in current episode of care at clinical partner site, for at least 6 weeks but less than 3 years.
- •Able and willing to provide informed consent.
- •Able to read English, to provide informed consent and complete study instruments.
- •Able to use a smart phone to complete study instruments [phones with data plan will be provided for those without].
排除标准
- •Patients who do not meet inclusion criteria.
结局指标
主要结局
Change in reported health related quality of life (4-point scale), assessed via CDC HRQOL questionnaire
时间窗: 3 months after baseline, 6 months after baseline
Centers for Disease Control \& Prevention (CDC) Health Related Quality of Life (HRQOL) questionnaire, single item ranging from excellent (score=1) to poor (score=5).
Change in number of days mental/physical health were not good (in past 30 days), assessed via CDC HRQOL questionnaire.
时间窗: 3 months after baseline, 6 months after baseline
CDC Health Related Quality of Life (HRQOL) questionnaire, separate items for mental and physical health, single item measuring the number of days out of 30, where 0 is no days (better) and 30 is daily (worse).
Change in reported self-efficacy for managing chronic conditions, assessed via PROMIS Self-Efficacy measure
时间窗: 3 months after baseline, 6 months after baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy scale, a series of 10 questions each on a 5-point scale, ranging from not at all confident (score=1) to very confident (score=5).
Change in patient-clinician alliance, assessed via WAI-SR
时间窗: 3 months after baseline, 6 months after baseline
Working Alliance Inventory-Short Revised (WAI-SR): Patient-clinician alliance for tasks and goals of treatment, and effective relationship. This scale is a series of 12 items, with responses ranging from seldom (score=1) to always (score=5).
次要结局
- Social determinants of health, assessed via PRAPARE(3 months after baseline, 6 months after baseline)
- Substance use past 30 days, assessed via modified ASI Alcohol and Drug module(3 months after baseline, 6 months after baseline)
研究者
Sharon Reif
Professor
Brandeis University