NCT05658796 RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty
| NCT ID | NCT05658796 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Mood Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-01-27 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-01-27 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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.
Contact & Investigator
Ata Murat Kaynar, MD, MPH
PRINCIPAL INVESTIGATOR
UPMC Department of Anesthesiology and Perioperative Medicine
Frequently Asked Questions
Who can join the NCT05658796 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Mood Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05658796 currently recruiting?
Yes, NCT05658796 is actively recruiting participants. Contact the research team at kaynarm@upmc.edu for enrollment information.
Where is the NCT05658796 trial being conducted?
This trial is being conducted at Monroeville, United States, Pittsburgh, United States, Pittsburgh, United States.
Who is sponsoring the NCT05658796 clinical trial?
NCT05658796 is sponsored by University of Pittsburgh. The principal investigator is Ata Murat Kaynar, MD, MPH at UPMC Department of Anesthesiology and Perioperative Medicine. The trial plans to enroll 150 participants.