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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Opioid Use Disorder; Substance Use Disorders
• Intervention / Treatment: Other: Patient Reported Outcome Measure

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Stanley Street Resources and Treatment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Recovery PROM; All study participants will complete the Recovery PROM instrument.

Other: Patient Reported Outcome Measure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social determinants of health, assessed via PRAPARE	Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences (PRAPARE). The prepare is a series of independent questions related to social determinants of health; it is not scored.	3 months after baseline, 6 months after baseline
Substance use past 30 days, assessed via modified ASI Alcohol and Drug module	Modified Alcohol and Drug module of the Addiction Severity Index (ASI). The ASI asks how many days in the past 30 each substance was used, where 0 is no use (better) and 30 days is daily use (worse).	3 months after baseline, 6 months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Recovery PROM	Self-developed questions. These are independent questions. Each is scored on a scale of 1 to 5, where 1 is the best outcome (e.g., extremely satisfied) and 5 is the worst outcome (e.g., extremely unsatisfied).	6 months after baseline

Collaborators and Investigators

• Sponsor: Brandeis University
• Collaborators: National Institute on Drug Abuse (NIDA); Stanley Street Treatment and Resources (SSTAR)
• Investigators: Principal Investigator: Sharon Reif, PhD, Brandeis University; Principal Investigator: Constance M Horgan, ScD, Brandeis University

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Recovery; Patient reported outcome measure; Measure development
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 19123R; R61DA049263 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No