Substance Use DisordersRecoveryPROMNCT05388045
Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting
A study testing Patient Reported Outcome Measure in people with Substance Use Disorders and Opioid Use Disorder, run by Brandeis University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Opioid Use Disorder
- What is being tested?
- Patient Reported Outcome Measure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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].
Who cannot join
- Patients who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanley Street Resources and Treatment
Fall River, Massachusetts, 02720
About this study
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.
Read the 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:
- 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.
- 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.
- 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
- Being tested
- Patient Reported Outcome Measure
- Keywords
- Patient reported outcome measure, Recovery, Measure development
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcome MeasureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Recovery PROM | Experimental | All study participants will complete the Recovery PROM instrument. Receives: Other: Patient Reported Outcome Measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 3 months after baseline, 6 months after baseline
Secondary outcomes (2)
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.
Measured: 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).
Measured: 3 months after baseline, 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start14 Apr 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- No randomization is involved, with all eligible patients invited to participate.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brandeis University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Street Treatment and Resources (SSTAR), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Sharon Reif, Brandeis University
- Investigators
- Sharon Reif, PhD, Principal investigator, Brandeis UniversityConstance M Horgan, ScD, Principal investigator, Brandeis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388045
- Sponsor's protocol ID
- 19123R
- Other IDs
- R61DA049263
- Acronym
- RecoveryPROM
- Status last verified
- Jul 2023
- First submitted
- 13 May 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okrant E, Reif S, Bailey GL, Horgan CM, Lee MT, Brown MA, Simas BL, Alfaro KA, Ritter GA. Using a quality improvement framework to evaluate the feasibility of implementing a patient-reported outcome measure for recovery in an office-based treatment setting for opioid use disorder. Addict Sci Clin Pract. 2025 Dec 22;21(1):15. doi: 10.1186/s13722-025-00632-4.
PubMed 41430618Okrant 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.
PubMed 37658373
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting
- ClinicalTrials.gov ID
- NCT05388045
- Acronym / sponsor ID
- RecoveryPROM / 19123R
- Conditions
- Substance Use Disorders, Opioid Use Disorder
- Keywords
- Patient reported outcome measure, Recovery, Measure development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brandeis UniversityUniversity, hospital or other
- Collaborators
- Stanley Street Treatment and Resources (SSTAR), National Institute on Drug Abuse (NIDA)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- No randomization is involved, with all eligible patients invited to participate.
| Arm | Type | Receives |
|---|---|---|
| Recovery PROM | Experimental | Other: Patient Reported Outcome MeasureAll study participants will complete the Recovery PROM instrument. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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].
Key exclusion criteria (1 listed)
- Patients who do not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Reported Outcome MeasureA 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. | Other | Recovery PROM |
Primary outcome
Change in reported health related quality of life (4-point scale), assessed via CDC HRQOL questionnaire
Time frame: 3 months after baseline, 6 months after baseline
Centers for Disease Control \& Prevention (CDC) Health Related Quality of Life (HRQOL) questionnaire, single item ranging from excellent (score=1) to poor (score=5).
Change in number of days mental/physical health were not good (in past 30 days), assessed via CDC HRQOL questionnaire.
Time frame: 3 months after baseline, 6 months after baseline
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).
Change in reported self-efficacy for managing chronic conditions, assessed via PROMIS Self-Efficacy measure
Time frame: 3 months after baseline, 6 months after baseline
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).
Change in patient-clinician alliance, assessed via WAI-SR
Time frame: 3 months after baseline, 6 months after baseline
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).
2 secondary outcomes
Social determinants of health, assessed via PRAPARE
Time frame: 3 months after baseline, 6 months after baseline
Substance use past 30 days, assessed via modified ASI Alcohol and Drug module
Time frame: 3 months after baseline, 6 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 41430618Okrant E, Reif S, Bailey GL, Horgan CM, Lee MT, Brown MA, Simas BL, Alfaro KA, Ritter GA. Using a quality improvement framework to evaluate the feasibility of implementing a patient-reported outcome measure for recovery in an office-based treatment setting for opioid use disorder. Addict Sci Clin Pract. 2025 Dec 22;21(1):15. doi: 10.1186/s13722-025-00632-4.
- Derived from this study: PubMed 37658373Okrant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Reif, PhD principal investigator
Brandeis University
Constance M Horgan, ScD principal investigator
Brandeis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Reported Outcome Measure in people with Substance Use Disorders and Opioid Use Disorder, run by Brandeis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reported health related quality of life (4-point scale), assessed via CDC HRQOL questionnaire (time frame: 3 months after baseline, 6 months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388045, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.