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| ID | Type | Description | Link |
|---|---|---|---|
| R61DA049263 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Stanley Street Treatment and Resources (SSTAR) | UNKNOWN |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recovery PROM | Experimental | All study participants will complete the Recovery PROM instrument. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Patients:
Exclusion Criteria:
• Patients who do not meet inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Reif, PhD | Brandeis University | Principal Investigator |
| Constance M Horgan, ScD | Brandeis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanley Street Resources and Treatment | Fall River | Massachusetts | 02720 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41430618 | Derived | 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. | |
| 37658373 | Derived | 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. |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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No randomization is involved, with all eligible patients invited to participate.
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The intervention is not blinded to patients, clinicians, or investigators.
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|
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 |
| D008919 |
| Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |