UnknownNot Applicable

Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting

United States100 participantsStarted 2022-04-14

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients: * 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 \[phones with data plan will be provided for those without\]. Exclusion Criteria: • Patients who do not meet inclusion criteria.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in reported health related quality of life (4-point scale), assessed via CDC HRQOL questionnaire

Timeframe: 3 months after baseline, 6 months after baseline

Change in number of days mental/physical health were not good (in past 30 days), assessed via CDC HRQOL questionnaire.

Timeframe: 3 months after baseline, 6 months after baseline

Change in reported self-efficacy for managing chronic conditions, assessed via PROMIS Self-Efficacy measure

Timeframe: 3 months after baseline, 6 months after baseline

Change in patient-clinician alliance, assessed via WAI-SR

Timeframe: 3 months after baseline, 6 months after baseline

Trial details

NCT IDNCT05388045

SponsorBrandeis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

View on ClinicalTrials.gov More Substance Use Disorders trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in reported health related quality of life (4-point scale), assessed via CDC HRQOL questionnaire

Timeframe: 3 months after baseline, 6 months after baseline

Change in number of days mental/physical health were not good (in past 30 days), assessed via CDC HRQOL questionnaire.

Timeframe: 3 months after baseline, 6 months after baseline

Change in reported self-efficacy for managing chronic conditions, assessed via PROMIS Self-Efficacy measure

Timeframe: 3 months after baseline, 6 months after baseline

Change in patient-clinician alliance, assessed via WAI-SR

Timeframe: 3 months after baseline, 6 months after baseline