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

NCT05388045 | Unknown

• 2 other identifiers: 19123RR61DA049263
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Opioid Use Disorder

Keywords

Patient reported outcome measure; Recovery; Measure development

Outcome Measures

Primary Outcomes (4)

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

  Centers for Disease Control \& Prevention (CDC) Health Related Quality of Life (HRQOL) questionnaire, single item ranging from excellent (score=1) to poor (score=5).

  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.

  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).

  3 months after baseline, 6 months after baseline

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

  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).

  3 months after baseline, 6 months after baseline

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

  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).

  3 months after baseline, 6 months after baseline

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Satisfaction with Recovery PROM

  6 months after baseline

Study Arms (1)

Recovery PROM

EXPERIMENTAL

All study participants will complete the Recovery PROM instrument.

Other: Patient Reported Outcome Measure

Interventions

Patient Reported Outcome Measure OTHER

A Recovery Patient-Reported Outcome Measure (PROM, 19 items and 2 questions for each item, collected via online survey) will be completed by eligible patients at baseline and again at months 3 and 6. The initial Recovery PROM will be shared with the clinician, at the visit most closely scheduled following the baseline visit, for review and discussion with the patient. At the 3- and 6-month visits, the clinician will be asked to re-review and compare the earlier Recovery PROM(s) as well as the current Recovery PROM. The clinician is encouraged to use the PROM results during interim clinical visits with the patient. Efforts will be made to contemporaneously track how often the PROM is discussed in clinical sessions conducted during the 6 months.

Recovery PROM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[phones with data plan will be provided for those without\].

Sponsors & Collaborators

• Brandeis University: lead
• Stanley Street Treatment and Resources (SSTAR): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stanley Street Resources and Treatment

Fall River, Massachusetts, 02720, United States

Location

Related Publications (1)

• Okrant E, Reif S, Horgan CM. Development of an addiction recovery patient-reported outcome measure: Response to Addiction Recovery (R2AR). Subst Abuse Treat Prev Policy. 2023 Sep 1;18(1):52. doi: 10.1186/s13011-023-00560-z.

  PMID: 37658373 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Sharon Reif, PhD

  Brandeis University

  PRINCIPAL INVESTIGATOR

• Constance M Horgan, ScD

  Brandeis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The intervention is not blinded to patients, clinicians, or investigators.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: No randomization is involved, with all eligible patients invited to participate.

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 24, 2022
• Study Start: April 14, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)