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

Brandeis University

Status: Invitation-only

Conditions: Opioid Use Disorder; Substance Use Disorders

Treatments: Other: Patient Reported Outcome Measure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05388045

R61DA049263 (U.S. NIH Grant/Contract)

19123R

Details and patient eligibility

About

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.

Full description

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:

1. 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.
2. 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.
3. 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.

H1. Patients and clinicians will find the Recovery PROM to be a useful tool for patient recovery.

H2. Patient self-efficacy, shared decision-making, patient-provider relationship, and health-related quality of life will improve and substance use will decrease with the use of the Recovery PROM.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Recovery PROM

Experimental group

Description:

All study participants will complete the Recovery PROM instrument.

Treatment:

Other: Patient Reported Outcome Measure