Recruiting

RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty

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

ClinicalTrials.gov IDNCT05658796

PhaseNA

Enrollment150

SponsorUniversity of Pittsburgh

Age18 Years – 100 Years

SexALL

I'm interested View official listing

Conditions studied

Mood Disorders, Anxiety, Depressive Symptoms, Depression, Anxiety Disorders, Anxiety Depression

About this study

Interventions

Behavioral: +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. Subjects enrolled after 01DEC25 were unable to download the RxWell application because it was removed from the app store. To avoid disruption, direct access to the RxWell application was replaced with a 30-minute, directed, telemedicine, health coaching session, on at least 2 occasions prior to surgery.
Behavioral: -RxWell — Treatment as usual

Primary outcomes

Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg) (POD 1 to Week 4 Post-Op)

Eligibility information

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.

Study locations

UPMC East, Monroeville, Pennsylvania 15146 United States
UPMC Shadyside, Pittsburgh, Pennsylvania 15232 United States
UPMC Passavant, Pittsburgh, Pennsylvania 15237 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-20.