[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657512":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":33,"overallOfficials":13,"centralContacts":38,"locations":44,"responsibleParty":59,"collaborators":13,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":24,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":13,"enrollmentInfo":72,"targetDuration":13,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":85,"whyStopped":13,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Reach","Proportion of eligible patients randomized to Bup-MBC who complete ≥1 questionnaire; monthly completion rates with 95% confidence intervals","From enrollment to the end of the study period (12 months) or 6 months, whichever is shorter",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Eligible patients with an active bup-nx prescription under a participating prescriber are individually randomized 1:1 to receive Bup-MBC or usual care, stratified by prescriber. Clinicians are unblinded after assignment and may care for patients in both arms; Bup-MBC summaries and outreach options are available only for patients randomized to the intervention arm.","HEALTH_SERVICES_RESEARCH",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","Bup-MBC is an electronic health record-embedded implementation strategy designed to support evidence-based buprenorphine-naloxone (bup-nx) treatment for opioid use disorder (OUD) by integrating patient-reported outcome measures (PROMs) and related indicators into routine outpatient addiction care. The strategy comprises four components: (1) structured between-visit PROMs assessing withdrawal, craving, medication adherence, medication side effects, opioid overdose risk, other substance use, global treatment improvement, and recovery community connection; (2) automated non-punitive patient feedback immediately following PROM completion; (3) EHR-embedded longitudinal clinician-facing summaries with non-directive decision-support prompts; and (4) an opt-in between-visit outreach pathway with predefined safety overrides for critical disclosures. This pragmatic pilot hybrid type III effectiveness-implementation trial will enroll adults with an active bup-nx prescription at outpatient addiction clinics at Vanderbilt University Medical Center (Bridge Clinic, Vanderbilt Recovery Clinic, and Firefly Clinics). Providers will be individually randomized 1:1 to Bup-MBC or usual care. The 6-month observation period will evaluate implementation outcomes using the RE-AIM framework (Reach, Adoption, Implementation) as primary outcomes, and exploratory clinical outcomes including medication possession ratio, visit adherence, treatment retention, urgent refill requests, emergency department utilization, and urine drug screen results. Qualitative interviews with clinicians and clinic leadership will assess acceptability, feasibility, and sustainability. Bup-MBC and this study were developed following a qualitative needs assessment, systematic review of single-item PROMs for substance use treatment, and theory-guided intervention design using the Theoretical Domains Framework and COM-B.",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"Bup-MBC","EXPERIMENTAL","Patients seen by a provider randomized to Bup-MBC receive automated between-visit PROMs via patient portal or secure text, immediate tailored non-punitive feedback after completion, eligibility for clinician-facing EHR summaries with non-directive prompts, and an opt-in option to request earlier contact between visits, with predefined safety overrides for critical disclosures.",[28],"Behavioral: Bup-MBC",{"label":30,"type":31,"description":32,"interventionNames":13},"Usual care","NO_INTERVENTION","Patients seen by a provider randomized to usual care continue to receive standard buprenorphine-naloxone treatment and routine clinic services without PROM invitations or Bup-MBC components.",[34],{"type":35,"name":24,"description":36,"armGroupLabels":37,"otherNames":13},"BEHAVIORAL","Electronic health record-embedded implementation strategy comprising four components: (1) brief repeated PROMs delivered via patient portal or secure text (domains: withdrawal, craving, bup-nx adherence, medication side effects, opioid overdose risk, other substance use, global treatment improvement, recovery community connection); (2) automated non-punitive tailored patient feedback following each PROM; (3) longitudinal EHR-embedded clinician-facing summaries with non-directive clinical decision support prompts; (4) opt-in between-visit outreach pathway with predefined safety triggers for urgent follow-up. PROM frequency is adapted to treatment phase and clinical stability.",[24],[39],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},"Thomas Reese, PharmD, PhD","CONTACT","6153228682","thomas.reese@vumc.org",[45],{"facility":5,"status":13,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Nashville","Tennessee","37203","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-86.78444,36.16589,{"lat":55,"lon":54},[58],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Thomas Reese","Assistant Professor","100657512","measurement-based-care-to-support-buprenorphine-naloxone-treatment-in-outpatient-addiction-clinics-100657512",false,"NCT07839182","Measurement-Based Care to Support Buprenorphine-Naloxone Treatment in Outpatient Addiction Clinics","Measurement-based Care to Support Delivery of Buprenorphine-naloxone Treatment in Outpatient Addiction Clinics","Inclusion Criteria:\n\n* Adult (age ≥18)\n* Active bup-nx prescription under a participating prescriber at one of the VUMC addiction clinics\n* Enrolled in and active in the respective clinic\n* Activated patient portal account\n\nExclusion Criteria:\n\n* Patients who are incarcerated or under correctional custody such that research procedures cannot be conducted.\n* Patients unable to provide informed consent because of severe cognitive impairment or acute intoxication at the time of approach, as judged by the treating clinician.\n* Patients whose clinicians judge that participation would pose undue risk or burden (e.g., acute psychiatric crisis where additional questionnaires would be inappropriate).","ALL","18 Years",{"count":73,"type":74},140,"ESTIMATED","INTERVENTIONAL",[77],"NA","People receiving buprenorphine-naloxone (bup-nx) for opioid use disorder often face changes in cravings, withdrawal, and return to use risk between clinic visits, but their care team may not know about these changes until the person misses an appointment or returns to drug use. Measurement-based care (MBC) uses brief, repeated check-ins from patients to make these between-visit changes visible. This study tests \"Bup-MBC,\" a strategy that sends patients short questionnaires through their patient portal or by text before and between visits, gives them immediate supportive feedback, shares summary information with their prescriber in the electronic health record, and offers an option to request earlier contact if concerns arise. The study will include providers and patients at outpatient addiction clinics at Vanderbilt University Medical Center, randomly assigned to either receive Bup-MBC or usual care, and followed for 6 months. The main goal is to determine whether Bup-MBC can be practically delivered in routine addiction clinics and whether patients and providers use it.",[80],"Opioid Use Disorder",[82,83,84],"patient-reported outcome measures","implementation science","measurement-based care","NOT_YET_RECRUITING","2026-09-25",{"date":88,"type":89},"2026-09-30","ACTUAL",{"date":91,"type":74},"2026-12-01",{"date":93,"type":74},"2027-12-01",{"name":5,"class":6},1]