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

NCT ID: NCT05388045

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2023-11-01

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.

Conditions

Substance Use Disorders; Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Recovery PROM

All study participants will complete the Recovery PROM instrument.

Group Type: EXPERIMENTAL

Patient Reported Outcome Measure

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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].

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Street Treatment and Resources (SSTAR)

UNKNOWN

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Brandeis University

OTHER

Sponsor Role: lead

Responsible Party

Sharon Reif

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon Reif, PhD

Role: PRINCIPAL_INVESTIGATOR

Brandeis University

Constance M Horgan, ScD

Role: PRINCIPAL_INVESTIGATOR

Brandeis University

Locations

Stanley Street Resources and Treatment

Fall River, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37658373 (View on PubMed)

Other Identifiers

R61DA049263

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19123R

Identifier Type: -

Identifier Source: org_study_id