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

Last updated: May 5, 2025
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Anxiety Disorders

Mood Disorders

Treatment

+RxWell

-RxWell

Clinical Study ID

NCT05658796
STUDY21120053
R21DA061414-01
  • Ages > 18
  • All Genders

Study 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

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 Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: +RxWell
Phase:
Study Start date:
January 27, 2023
Estimated Completion Date:
July 31, 2025

Study Description

The content of the digital behavioral tool was developed based on standard Cognitive Behavioral Therapy (CBT) techniques. An additional layer of support includes a behavioral health coach who provides guidance and motivation throughout the use of the app via in-app text messaging.

This approach has already been tested at UPMC on multiple adult clinical populations. This project represents the first pilot of the digital behavioral tool with perioperative patients

The digital behavioral tool can provide a resource gap by providing preventive mental health services to promote mental health wellness for patients to help reduce the deleterious impact of established mood disorders on recovery following primary total knee replacements including:

  • pain and opioid requirement,

  • functional recovery,

  • decrease complications, and

  • reduce resources utilization such as hospital length of stay, postoperative need for visits and the use of rehabilitation.

    1. Determine the feasibility of using RxWell for patients undergoing elective surgery who have mood disorder symptoms using MyUPMC platform and established either at the time of visiting the Center for Perioperative Care (CPC) either in-person or via anesthesia telemedicine services (ATS) in a tertiary care system.

    2. Determine the impact of RxWell-associated improvements in anxiety, depression, and catastrophizing on postoperative outcomes with a special focus on resources utilization.

Subjects who choose to sign electronically will be provided a link via email for REDCap. This link will include an electronic consent document and the ability to sign with a computer cursor, stylus, or their finger depending on the device the subject uses to access this link.

Connect with a study center

  • UPMC East

    Monroeville, Pennsylvania 15146
    United States

    Active - Recruiting

  • UPMC Passavant

    Pittsburgh, Pennsylvania 15237
    United States

    Active - Recruiting

  • UPMC Shadyside

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • UPMC St. Margaret

    Pittsburgh, Pennsylvania 15215
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.