RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty
RxWell
Telemedicine-delivered Digital Cognitive Behavioral Intervention to Decrease Post-operative Opioid Use Among Patients Undergoing Total Knee or Hip Arthroplasty
2 other identifiers
interventional
150
1 country
3
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2022
CompletedFirst Posted
Study publicly available on registry
December 21, 2022
CompletedStudy Start
First participant enrolled
January 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
November 5, 2025
August 1, 2025
3.8 years
July 26, 2022
November 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Opioid prescription refills by 3 months
Post-Op Month 3
Pain at Rest
Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7
Pain with Movement
Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7
Persistent Opioid Use
Post-Op 1 Month, Post-Op 3 Months
Study Arms (3)
Control
ACTIVE COMPARATORNo 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
Intervention: RxWell
EXPERIMENTALRxWell 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.
Control (screen failures)
NO INTERVENTIONWe will collect data on patient outcomes for patients that did not meet criteria for the RxWell intervention.
Interventions
Eligibility Criteria
You may qualify if:
- 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/or PROMIS Depression4a short form
You may not qualify if:
- 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 /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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- National Institutes of Health (NIH)collaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (3)
UPMC East
Monroeville, Pennsylvania, 15146, United States
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232, United States
UPMC Passavant
Pittsburgh, Pennsylvania, 15237, United States
Related Publications (1)
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.
PMID: 37946291DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ata Murat Kaynar, MD, MPH
UPMC Department of Anesthesiology and Perioperative Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 26, 2022
First Posted
December 21, 2022
Study Start
January 27, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
November 5, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share