[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04598074":3,"trial-entities:NCT04598074":170,"trial-summary:NCT04598074":175},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":39,"primary_purpose":40,"phases":41,"enrollment_info":43,"interventions":46,"primary_outcomes":54,"secondary_outcomes":77,"sex":134,"minimum_age":135,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":136,"std_ages":140,"locations":143,"central_contacts":163,"overall_officials":165,"references":168,"see_also_links":169},"NCT04598074","20-210S-1","Opioid Package Prototype (OPP)","The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes","NOT_YET_RECRUITING","2026-09-30","2025-08","2025-09-05","2025-09-07","UConn Health","OTHER",false,"The overall objective of this clinical trial is to identify the impact of selected package features, known as the Opioid Package Prototype (OPP), on the safe and effective use of opioids. Our specific aims are: (Aim 1) to evaluate the effectiveness of OPP on prescribing, dispensing, and patient use of oxycodone among orthopaedic surgery patients receiving post-operative outpatient oxycodone for post-surgical pain management, and (Aim 2) to determine the feasibility of OPP for orthopaedic surgery prescribers, pharmacists, and orthopaedic surgery patients. Such data can be used to further optimize packaging and labeling design, help patients and caregivers utilize their medication and packaging correctly, and improve prescribing and dispensing habits. The central hypothesis is that the OPP will be more effective than the amber vial in efforts to reduce oxycodone prescribing among patients over 18 receiving short-term management of post orthopedic surgery pain.",null,[19,20],"Opioid Use","Opioid Prescribing, Dispensing, and Patient Use",[22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38],"oxycodone","opioid","opioids","package","packaging","post-surgical pain","post-operative pain","orthopedic","orthopaedic","surgery","dispensing","prescribing","blister","tablets","pain","opioid package prototype","OPP","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[42],"NA",{"count":44,"type":45},352,"ESTIMATED",[47,50],{"type":14,"name":6,"description":48,"armGroupLabels":49},"The Opioid Package Prototype (OPP) is a child-resistant\u002Fsenior-friendly, calendar-blister packaging of limited pill counts with flat readable billboard space for medication labeling.",[6],{"type":14,"name":51,"description":52,"armGroupLabels":53},"Usual Care (standard amber vial)","The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.",[51],[55,59,61,63,66,67,68,71,72,73,75,76],{"measure":56,"description":57,"timeFrame":58},"Number of tablets of oxycodone prescribed","Count via medical\u002Fpharmacy records","1 week after surgery",{"measure":56,"description":57,"timeFrame":60},"1 month after surgery",{"measure":56,"description":57,"timeFrame":62},"3 months after surgery",{"measure":64,"description":65,"timeFrame":58},"Average morphine milligram equivalent (MME) of oxycodone tablets prescribed\u002Fper participant","Mean",{"measure":64,"description":65,"timeFrame":60},{"measure":64,"description":65,"timeFrame":62},{"measure":69,"description":70,"timeFrame":58},"Number of oxycodone tablets used by study participants","Count via survey\u002Finterview\u002Fvisual inspection\u002Fphotograph",{"measure":69,"description":70,"timeFrame":60},{"measure":69,"description":70,"timeFrame":62},{"measure":74,"description":65,"timeFrame":58},"Average morphine milligram equivalent (MME) of oxycodone tablets used\u002Fper participant",{"measure":74,"description":65,"timeFrame":60},{"measure":74,"description":65,"timeFrame":62},[78,82,86,89,93,97,100,102,106,109,112,115,118,122,126,130],{"measure":79,"description":80,"timeFrame":81},"Number of requests for additional oxycodone prescriptions","Count per patient survey\u002Finterview","1 week, 1 month and 3 months after surgery",{"measure":83,"description":84,"timeFrame":85},"Amount of dispensing time per oxycodone prescription for each study participant","Log of dispensing start time (received prescription) and dispensing stop time (prescription ready for pick up)","Time of surgery and any refills up to 1 month after surgery",{"measure":87,"description":88,"timeFrame":85},"Amount of counseling time per oxycodone prescription for each study participant","Log of counseling start time (start to discuss medication information) and counseling stop time (complete discussion of medication information)",{"measure":90,"description":91,"timeFrame":92},"Awareness of oxycodone tablets used","Amount of time to report number of tablets used via brief inspection of container (not manual count) during interview and various survey questions","1 week and 1 month after surgery",{"measure":94,"description":95,"timeFrame":96},"Change in knowledge of oxycodone from baseline to 1 week","Number of correct answers out of 4 knowledge questions","Baseline (before surgery) and 1 week after surgery",{"measure":98,"description":99,"timeFrame":92},"Awareness of oxycodone medication information","Various survey\u002Finterview questions",{"measure":101,"description":99,"timeFrame":92},"Consistency of access to oxycodone medication information",{"measure":103,"description":104,"timeFrame":105},"SANE (Single Assessment Numeric Evaluation) score","\"How would you rate your affected joint\u002Fregion of interest today as a percentage of normal (0% to 100% scale with 100% being normal)?\"","Baseline, 1 week, 1 month and 3 months after surgery",{"measure":107,"description":108,"timeFrame":105},"PEG (Pain, Enjoyment of Life and General Activity) score","A three-item scale assessing pain intensity and interference from 0-10. The three item scores are averaged for a final score and a higher number indicates greater pain and interference.",{"measure":110,"description":111,"timeFrame":105},"Pain Medication Attitudes Questionnaire (PMAQ-14) score","Participants indicate the degree to which they agree with 14 statements regarding pain medication from 0 (never true) to 5 (always true). The 14 scores are averaged for a final score and a higher number indicates a more negative attitude toward pain medications,",{"measure":113,"description":114,"timeFrame":105},"Pain Catastrophizing Scale (PCS)","A 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.",{"measure":116,"description":117,"timeFrame":81},"Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS)","A 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores.",{"measure":119,"description":120,"timeFrame":121},"Patient Health Questionnaire-4 (PHQ-4)","A 4-item inventory rated on a 4-point Likert-type scale to assess for anxiety and depression. The minimum score (0) indicates no psychological distress and the maximum score (12) indicates severe psychological distress.","Baseline, 1 week and 1 month after surgery",{"measure":123,"description":124,"timeFrame":125},"Feasibility of OPP for orthopaedic surgery prescribers","Interview regarding benefits and weaknesses of the OPP design, interest in prescribing OPP in the future, and how OPP design can be improved for the future","Within 1 month after prescribing the OPP to 30 participants",{"measure":127,"description":128,"timeFrame":129},"Feasibility of OPP for pharmacists","Interview questions regarding benefits and weaknesses of the OPP design, interest in dispensing OPP in the future, and how OPP design can be improved for the future","After dispensing all OPPs (approximately 2 years)",{"measure":131,"description":132,"timeFrame":133},"Feasibility of OPP for orthopaedic surgery patients","Interview questions regarding benefits and weaknesses of the OPP design, interest in using OPP in the future, and how OPP design can be improved for the future","Between 1 and 3 months after surgery","ALL","18 Years",{"inclusion":137,"exclusion":138,"raw_text":139},[],[],"Inclusion Criteria:\n\n1. The patient is 18 years and older;\n2. The patient is one of the participating surgeons;\n3. The patient is receiving orthopaedic surgery that involves the use of opioid medication for post-operative pain;\n4. The patient is willing to receive oxycodone medication;\n5. The patient is willing and able to receive medication at the UConn Health Specialty Pharmacy, located in the Exchange across the street from the main entrance of UConn Health;\n6. The patient is willing and able to use a MyChart account;\n7. The patient is able to read and understand English; and\n8. The patient is able to understand the study procedures and their involvement in the study.\n\nExclusion Criteria:\n\n\\-",[141,142],"ADULT","OLDER_ADULT",[144],{"facility":13,"city":145,"state":146,"zip":147,"country":148,"contacts":149,"geoPoint":160},"Farmington","Connecticut","06030","United States",[150,155,157],{"name":151,"role":152,"phone":153,"email":154},"Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA","CONTACT","860-486-6026","nathaniel.rickles@uconn.edu",{"name":151,"role":156},"PRINCIPAL_INVESTIGATOR",{"name":158,"role":159},"Katherine J Coyner, MD, FAOA","SUB_INVESTIGATOR",{"lat":161,"lon":162},41.71982,-72.83204,[164],{"name":151,"role":152,"phone":153,"email":154},[166],{"name":151,"affiliation":167,"role":156},"University of Connecticut",[],[],{"nct_id":4,"conditions":171,"biomarkers":174},[172,173],"Orthopedic Rehabilitation Surgery","Post-Operative Pain",[],{"nct_id":4,"found":176,"summary":177,"prompt_version":187},true,{"design":178,"status":179,"heading":180,"summary":181,"follow_up":182,"word_count":183,"commitments":184,"compensation":185,"drugs_mentioned":186},"This interventional study plans to enroll 352 participants. It compares the Opioid Package Prototype (OPP) to standard amber vials for dispensing oxycodone.","completed","Opioid Package Prototype (OPP) for Post-Surgery Pain","This study is looking at a new type of packaging for oxycodone, a pain medication, called the Opioid Package Prototype (OPP). This new package is child-resistant and senior-friendly, with a calendar-blister design and space for clear labeling. Researchers want to see if this new packaging helps doctors prescribe, pharmacies dispense, and patients use oxycodone more safely and effectively after orthopedic surgery. You might be able to join if you are 18 or older, having orthopedic surgery that requires oxycodone for pain, and are willing to receive oxycodone. The study will measure how many oxycodone tablets are prescribed at 1 week, 1 month, and 3 months after surgery. The current status of this study is unclear.","The study will measure the number of oxycodone tablets prescribed at 1 week, 1 month, and 3 months after surgery.",115,"Not specified in the trial record.","Not stated in the trial record.",[6],"v2"]