RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty
NCT ID: NCT05658796
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-01-27
2026-12-30
Brief Summary
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Detailed Description
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This 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
The 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:
* pain and opioid requirement,
* functional recovery,
* decrease complications, and
* reduce resources utilization such as hospital length of stay, postoperative need for visits and the use of rehabilitation.
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.
2. Determine the impact of RxWell-associated improvements in anxiety, depression, and catastrophizing on postoperative outcomes with a special focus on resources utilization.
Subjects 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
No intervention (No RxWell). Subjects will receive standard of care and education regarding potential resources for anxiety and depression. Subjects will complete questionnaires via REDCap assessing primary and secondary outcomes
-RxWell
Treatment as usual
Intervention: RxWell
RxWell Intervention. Subjects will receive standard of care and digital cognitive behavioral intervention by using the application RxWell. Subjects will complete questionnaires via REDCap assessing primary and secondary outcomes and will complete GAD-7 (Generalized Anxiety Disorder Scale) and PHQ-8 (Patient Health Questionnaire for Depression) every 2 weeks within the RxWell application.
+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/or 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.
Control (screen failures)
We will collect data on patient outcomes for patients that did not meet criteria for the RxWell intervention.
No interventions assigned to this group
Interventions
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+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/or 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.
-RxWell
Treatment as usual
Eligibility Criteria
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Inclusion Criteria
* 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/or PROMIS Depression4a short form
Exclusion Criteria
* 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 /or 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/or Depression T-score \>70, which corresponds to severe anxiety and depression.
* Patients needing immediate care will be referred to psychiatrists and primary team.
18 Years
100 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Ata Murat Kaynar
Professor
Principal Investigators
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Ata Murat Kaynar, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
UPMC Department of Anesthesiology and Perioperative Medicine
Locations
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UPMC East
Monroeville, Pennsylvania, United States
UPMC Shadyside
Pittsburgh, Pennsylvania, United States
UPMC Passavant
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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/s13063-023-07634-0.
Other Identifiers
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STUDY21120053
Identifier Type: -
Identifier Source: org_study_id
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