[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636476":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":73,"collaborators":24,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":24,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":24,"enrollmentInfo":84,"targetDuration":24,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":101,"whyStopped":24,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Usual Care (Control Period)","During the control phase of the stepped wedge cluster randomized trial, participating hospitals continue opioid prescribing according to existing local practices. Clinicians do not receive any components of the opioid stewardship intervention during this period. Each hospital contributes data to this arm prior to crossing over to the intervention phase based on randomized timing.",[12],"Other: Usual Care",{"label":14,"type":15,"description":16,"interventionNames":17},"Opioid Stewardship Intervention (Intervention Period)","EXPERIMENTAL","During the intervention phase, hospitals implement a multi component opioid stewardship intervention after crossing over from the control condition according to randomized start time. Clinician participants at each site engage in the intervention for approximately 10 weeks. All hospitals eventually receive the intervention as part of the stepped wedge design.",[18],"Behavioral: Opioid Stewardship Intervention",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Usual Care","Existing opioid prescribing practices and guidelines at each participating hospital site, with no additional educational, benchmarking, or quality improvement activities.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"BEHAVIORAL","Opioid Stewardship Intervention","A multi component intervention consisting of dissemination of the Standard Opioid Prescribing (SOPS) Toolkit, quality improvement educational sessions for clinicians, and benchmarked opioid prescribing performance reports generated from administrative claims data. Reports provide deidentified surgeon and site level summaries of opioid prescribing patterns.",[14],[31],{"name":32,"affiliation":5,"role":33},"Jessica Schumacher, PhD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","(919) 966-4320","Jessica_Schumacher@med.unc.edu",{"name":40,"role":36,"phone":24,"phoneExt":24,"email":41},"Meaghan Hazelet","meaghan.hazelet@med.unc.edu",[43,60],{"facility":44,"status":24,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27514","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-79.05584,35.9132,{"lat":54,"lon":53},[57,59],{"name":32,"role":36,"phone":58,"phoneExt":24,"email":38},"919-966-4320",{"name":32,"role":33,"phone":24,"phoneExt":24,"email":24},{"facility":61,"status":24,"city":62,"state":46,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Novant Health New Hanover Regional Medical Center","Wilmington","28401",{"type":51,"coordinates":65},[66,67],-77.94604,34.23556,{"lat":67,"lon":66},[70],{"name":71,"role":36,"phone":24,"phoneExt":24,"email":72},"William Hope, MD","william.hope@novanthealth.org",{"type":74,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100636476","reducing-post-operative-opioid-prescribing-in-southeastern-north-carolina-100636476",false,"NCT07566182","Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina","Building an Implementation Science Network to Reduce Post-Operative Opioid Prescribing in Southeastern North Carolina","Inclusion Criteria:\n\nSurgeon champions and identified change team members must be currently practicing at one of the sites participating in this study.\n\nPatient representatives must be:\n\nProficient in the English language Prescribed opioids following a qualifying general surgery procedure (inpatient or outpatient laparoscopic appendectomy, inguinal\u002Ffemoral hernia repair, umbilical hernia, bariatric\u002Fweight loss surgery, mastectomy, laparoscopic cholecystectomy, laparoscopic colectomy, lipoma\u002Fsoft tissue tumor excision, and anal\u002Frectal procedures).\n\nNo patients will be enrolled for this trial. However, claims data will be used to assess the claims based outcome measure (opioid prescribing).\n\nInclusion criteria for the claims analysis includes:\n\nPatients greater than or equal to 18 at the time of a qualifying general surgery procedure either inpatient or outpatient (laparoscopic appendectomy; umbilical\u002Fventral\u002Finguinal\u002Ffemoral hernia repair; bariatric\u002Fweight loss surgery; mastectomy; laparoscopic cholecystectomy; laparoscopic colectomy; lipoma\u002Fsoft tissue tumor excision; anal\u002Frectal procedures) based on procedure codes Patients must have continuous insurance coverage (including prescription drug coverage), 6 months before to 60 days post discharge to assess comorbidities and prescription drug fills.\n\nExclusion Criteria:\n\nPatients with an opioid fill 6 months before the procedure. Patients who undergo a significant operation during the stay associated with their index procedure that would require additional pain management.","ALL","18 Years",{"count":85,"type":86},40,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this stepped-wedge cluster randomized trial is to evaluate whether an opioid stewardship intervention improves post-operative opioid prescribing practices. Participants will include surgeon champions and identified change team members (e.g., pharmacists, hospitalists, nurses, advanced practice providers, anesthesiologists, etc.) and patient representatives at designated hospital sites in North Carolina.\n\nThe main questions it aims to answer are:\n\nI. Does the intervention reduce postoperative opioid prescribing behavior at the surgeon and hospital level? II. Is the intervention acceptable, feasible, and effective for implementation among participating hospitals?\n\nResearchers will compare opioid prescribing and implementation outcomes across sites before and after implementation using a stepped-wedge cluster randomized design, in which sites are randomly assigned to different intervention start times.\n\nParticipants will attend educational sessions delivered, introduce the Standard Opioid Prescribing (SOPS) Toolkit into their clinical practice, review benchmarked, deidentified opioid prescribing performance reports that use administrative claims data (secondary data source, data not collected or shared between hospitals), and complete surveys assessing intervention acceptability, feasibility, and effectiveness. Preliminary effectiveness will be assessed through reduction of opioid prescriptions using administrative claims data.",[92],"Opioid Prescribing",[94,95,96,97,98,99,100],"Opioid Stewardship","Postoperative opioid prescribing","Cluster randomized trial","Implementation science","Audit and feedback","Performance reporting","Quality Improvement","NOT_YET_RECRUITING","2026-04-28",{"date":104,"type":105},"2026-05-04","ACTUAL",{"date":107,"type":86},"2026-05-01",{"date":109,"type":86},"2027-12-31",{"name":5,"class":6},2]