Using RxWell to Reduce Opioid Use After Knee or Hip Surgery
Telemedicine-delivered Digital Cognitive Behavioral Intervention to Decrease Post-operative Opioid Use Among Patients Undergoing Total Knee or Hip Arthroplasty
This study is testing whether a digital tool called RxWell can help people with mood disorders who are having knee or hip surgery reduce their opioid use and improve their mental health after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 3 sites (Monroeville, Pennsylvania and 2 other locations) |
| Trial ID | NCT05658796 on ClinicalTrials.gov |
What this trial studies
This pilot project evaluates the RxWell digital behavioral tool designed to support patients with mood disorders undergoing elective total knee or hip arthroplasty. The tool incorporates Cognitive Behavioral Therapy techniques and includes guidance from a behavioral health coach through in-app messaging. The study aims to assess the feasibility of using RxWell to improve mental health outcomes and reduce postoperative complications, opioid use, and healthcare resource utilization. Participants will be recruited from UPMC hospitals and will be monitored for improvements in anxiety and depression symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for elective total knee or hip arthroplasty with moderate mood disorder symptoms.
Not a fit: Patients undergoing non-elective surgeries or those with severe mood disorders requiring immediate intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid use and improve recovery outcomes for patients undergoing joint replacement surgeries.
How similar studies have performed: Previous studies have shown promise in using digital behavioral tools for mental health support, but this specific application in perioperative care is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for the RXWell Study: * 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 Exclusion Criteria for the RXWell Study: * 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.
Where this trial is running
Monroeville, Pennsylvania and 2 other locations
- UPMC East — Monroeville, Pennsylvania, United States (Recruiting)
- UPMC Shadyside — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC Passavant — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Ata Murat Kaynar, MD, MPH — UPMC Department of Anesthesiology and Perioperative Medicine
- Study coordinator: Ata Murat Kaynar, MD, MPH
- Email: kaynarm@upmc.edu
- Phone: 412-383-3463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.