Clinical trial NCT05388045: Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting
Official title: Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Substance Use Disorders
Opioid Use Disorder
Keywords: Patient reported outcome measure
Recovery
Measure development
Lead sponsor: Brandeis University
Sponsor class: OTHER
Collaborators: name: Stanley Street Treatment and Resources (SSTAR)
name: National Institute on Drug Abuse (NIDA)
First posted: 2022-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: No randomization is involved, with all eligible patients invited to participate.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: 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
measure: Change in reported self-efficacy for managing chronic conditions, assessed via PROMIS Self-Efficacy measure
timeFrame: 3 months after baseline, 6 months after baseline
measure: Change in patient-clinician alliance, assessed via WAI-SR
timeFrame: 3 months after baseline, 6 months after baseline
Secondary outcomes:
measure: Social determinants of health, assessed via PRAPARE
timeFrame: 3 months after baseline, 6 months after baseline
measure: Substance use past 30 days, assessed via modified ASI Alcohol and Drug module
timeFrame: 3 months after baseline, 6 months after baseline
Other outcomes:
measure: Satisfaction with Recovery PROM
timeFrame: 6 months after baseline
Locations:
city: Fall River
country: United States
facility: Stanley Street Resources and Treatment
state: Massachusetts
Study officials:
affiliation: Brandeis University
name: Sharon Reif, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brandeis University
name: Constance M Horgan, ScD
role: PRINCIPAL_INVESTIGATOR
References: