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Recruiting
NCT05658796
RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty
Conditions: Mood Disorders, Anxiety, Depressive Symptoms, Depression, Anxiety Disorders, Anxiety Depression
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: University of Pittsburgh
Location: UPMC East Monroeville Pennsylvania
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.
Source: ClinicalTrials.gov (NCT05658796). StuddyBuddy aggregates publicly available trial information.