[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05658796":3,"trial-entities:NCT05658796":139,"trial-summary:NCT05658796":145},{"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":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":50,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":83,"locations":86,"central_contacts":123,"overall_officials":129,"references":133,"see_also_links":138},"NCT05658796","STUDY21120053","RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty","Telemedicine-delivered Digital Cognitive Behavioral Intervention to Decrease Post-operative Opioid Use Among Patients Undergoing Total Knee or Hip Arthroplasty","RECRUITING","2026-12-30","2026-06","2026-06-03","2023-01-27","University of Pittsburgh","OTHER",true,"It is envisioned that multipronged benefits from this pilot work for the UPMC ISD and its members. It is expected the RxWell platform to provide the following benefits: expansion of the use of RxWell to all UPMC ISD members providing peri-operative mood management with advantage of improved peri-operative outcomes, improving saving for the UPMC ISD by hastening the recovery and decreased resource utilization, and addition to the high-value care of UPMC with this holistic approach to patient perioperative care","The content of the digital behavioral tool was developed based on standard Cognitive Behavioral Therapy (CBT) techniques. An additional layer of support includes a behavioral health coach who provides guidance and motivation throughout the use of the app via in-app text messaging.\n\nThis approach has already been tested at UPMC on multiple adult clinical populations. This project represents the first pilot of the digital behavioral tool with perioperative patients\n\nThe digital behavioral tool can provide a resource gap by providing preventive mental health services to promote mental health wellness for patients to help reduce the deleterious impact of established mood disorders on recovery following primary total knee replacements including:\n\n* pain and opioid requirement,\n* functional recovery,\n* decrease complications, and\n* reduce resources utilization such as hospital length of stay, postoperative need for visits and the use of rehabilitation.\n\n  1. Determine the feasibility of using RxWell for patients undergoing elective surgery who have mood disorder symptoms using MyUPMC platform and established either at the time of visiting the Center for Perioperative Care (CPC) either in-person or via anesthesia telemedicine services (ATS) in a tertiary care system.\n  2. Determine the impact of RxWell-associated improvements in anxiety, depression, and catastrophizing on postoperative outcomes with a special focus on resources utilization.\n\nSubjects who choose to sign electronically will be provided a link via email for REDCap. This link will include an electronic consent document and the ability to sign with a computer cursor, stylus, or their finger depending on the device the subject uses to access this link.",[19,20,21,22,23,24],"Mood Disorders","Anxiety","Depressive Symptoms","Depression","Anxiety Disorders","Anxiety Depression",[],"INTERVENTIONAL","PREVENTION",[29],"NA",{"count":31,"type":32},150,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","+RxWell","During the SuRxgWell trial, if a participant is randomized to receive RxWell, they will be provided with an access code that is required to download the app. Once the participant has downloaded the app, they will be paired with a UPMC coach who will guide the person through the sessions using in-app texting to help give them the tools needed to actively cope with anxiety and\u002For depression. The UPMC coaches are supervised by a licensed UPMC mental health clinician. The participant will have access to the app and coach for six months after they have consented. The digital behavioral tool includes over 30 brief Cognitive Behavioral Therapy (CBT) and mindfulness-based techniques. Subjects enrolled after 01DEC25 were unable to download the RxWell application because it was removed from the app store. To avoid disruption, direct access to the RxWell application was replaced with a 30-minute, directed, telemedicine, health coaching session, on at least 2 occasions prior to surgery.",[39],"Intervention: RxWell",{"type":35,"name":41,"description":42,"armGroupLabels":43},"-RxWell","Treatment as usual",[44],"Control",[46],{"measure":47,"description":48,"timeFrame":49},"Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg)","This outcome will be measured by extracting pain medication data from the electronic health record to determine OME (oral morphine equivalents) (mg) for opioid medications on POD 1 and 2, and weeks 1 and 4 following surgery. This will be recorded for each study arm as mean (SD).","POD 1 to Week 4 Post-Op",[51,55,59,61],{"measure":52,"description":53,"timeFrame":54},"Opioid prescription refills by 3 months","This outcome will be measured by abstracting the PDMP review from the medical records to determine the number of opioid prescription refills by post-op month 3. This will be counted per patient and each arm will be recorded as a mean (SD).","Post-Op Month 3",{"measure":56,"description":57,"timeFrame":58},"Pain at Rest","Pain scores will be collected using a numerical rating scale (NRS) in which 0 = no pain at all, and 10 = worst pain imaginable. This outcome will be averaged in each arm and reported as mean (SD) for each timepoint provided in the time frame.","Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7",{"measure":60,"description":57,"timeFrame":58},"Pain with Movement",{"measure":62,"description":63,"timeFrame":64},"Persistent Opioid Use","This outcome will be measured by the number of participants still using opioids at the timepoints provided in the time frame. This is a binary yes\u002Fno response - yes, the subject is using opioids, no the subject is not using opioids and will be abstracted from the medical records.","Post-Op 1 Month, Post-Op 3 Months","ALL","18 Years","100 Years",false,{"inclusion":70,"exclusion":74,"raw_text":82},[71,72,73],"Adults \\>18 years","Scheduled for elective primary total knee arthroplasty (TKA) or hip replacement (THA) at the approved UPMC hospitals","Moderately high levels of mood disorder symptoms on validated PROMIS measures, defined as a T-score \\> or = to 60 on PROMIS Anxiety 4a short form and\u002For PROMIS Depression4a short form",[75,76,77,78,79,80,81],"Patients undergoing non-elective surgery or secondary arthroplasty","Active delirium, neurocognitive impairment, or severe intellectual disability","No access to a smart device (phone or tablet)","Active alcoholism (defined as daily use of more than 1 liter of wine and \u002For 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)","Profound mood disorders requiring immediate intervention such as suicidal ideation, defined as a PROMIS Depression score of more than 70","A PROMIS Anxiety and\u002For Depression T-score \\>70, which corresponds to severe anxiety and depression.","Patients needing immediate care will be referred to psychiatrists and primary team.","Inclusion Criteria for the RXWell Study:\n\n* Adults \\>18 years\n* Scheduled for elective primary total knee arthroplasty (TKA) or hip replacement (THA) at the approved UPMC hospitals\n* Moderately high levels of mood disorder symptoms on validated PROMIS measures, defined as a T-score \\> or = to 60 on PROMIS Anxiety 4a short form and\u002For PROMIS Depression4a short form\n\nExclusion Criteria for the RXWell Study:\n\n* Patients undergoing non-elective surgery or secondary arthroplasty\n* Active delirium, neurocognitive impairment, or severe intellectual disability\n* No access to a smart device (phone or tablet)\n* Active alcoholism (defined as daily use of more than 1 liter of wine and \u002For 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)\n* Profound mood disorders requiring immediate intervention such as suicidal ideation, defined as a PROMIS Depression score of more than 70\n* A PROMIS Anxiety and\u002For Depression T-score \\>70, which corresponds to severe anxiety and depression.\n\n  * Patients needing immediate care will be referred to psychiatrists and primary team.",[84,85],"ADULT","OLDER_ADULT",[87,106,116],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":103},"UPMC East","Monroeville","Pennsylvania","15146","United States",[94,99],{"name":95,"role":96,"phone":97,"email":98},"Ata Murat Kaynar, MD, MPH","CONTACT","412-383-3463","kaynarm@upmc.edu",{"name":100,"role":96,"phone":101,"email":102},"Amy Monroe, MPH, MBA","4126236382","monroeal@upmc.edu",{"lat":104,"lon":105},40.42118,-79.7881,{"facility":107,"status":8,"city":108,"state":90,"zip":109,"country":92,"contacts":110,"geoPoint":113},"UPMC Shadyside","Pittsburgh","15232",[111,112],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":102},{"lat":114,"lon":115},40.44062,-79.99589,{"facility":117,"status":8,"city":108,"state":90,"zip":118,"country":92,"contacts":119,"geoPoint":122},"UPMC Passavant","15237",[120,121],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":102},{"lat":114,"lon":115},[124,125],{"name":95,"role":96,"phone":97,"email":98},{"name":126,"role":96,"phone":127,"email":128},"Carly Riedmann, MPH","412-623-4147","riedmannca@upmc.edu",[130],{"name":95,"affiliation":131,"role":132},"UPMC Department of Anesthesiology and Perioperative Medicine","PRINCIPAL_INVESTIGATOR",[134],{"pmid":135,"type":136,"citation":137},"37946291","DERIVED","Kaynar AM, Lin C, Sanchez AG, Lavage DR, Monroe A, Zharichenko N, Strassburger M, Saucier K, Groff YJ, Klatt BA, O'Malley MJ, Szigethy E, Wasan AD, Chelly JE. SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery. Trials. 2023 Nov 9;24(1):715. doi: 10.1186\u002Fs13063-023-07634-0.",[],{"nct_id":4,"conditions":140,"biomarkers":144},[141,142,143],"Mood Disorder","Total Knee Replacement","Total replacement of hip",[],{"nct_id":4,"found":15,"summary":146,"prompt_version":156},{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This is an interventional study with a planned enrollment of 150 participants. It compares receiving the RxWell app with a coach to usual care.","completed","RXWell for Mood Symptoms Before Knee or Hip Replacement","This study is testing if a digital behavioral health tool called RxWell can help reduce the amount of opioid pain medication people need after total knee or hip replacement surgery. RxWell uses techniques from Cognitive Behavioral Therapy (CBT) and includes guidance from a UPMC coach through an app. You might be able to join if you are an adult (18-100 years old) scheduled for elective total knee or hip replacement at a UPMC hospital and have moderately high levels of mood disorder symptoms (anxiety or depression). The study will measure how much opioid medication you use from the day after surgery up to four weeks later. The current recruitment status is unclear.","Your opioid consumption will be measured from the day after surgery up to four weeks post-operation.",112,"If you receive RxWell, you will download an app and be paired with a UPMC coach who will guide you through sessions.","Not stated in the trial record.",[],"v2"]