RecruitingNot ApplicableNCT05658796

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

Telemedicine-delivered Digital Cognitive Behavioral Intervention to Decrease Post-operative Opioid Use Among Patients Undergoing Total Knee or Hip Arthroplasty

Sponsor

University of Pittsburgh

Enrollment

150 participants

Start Date

Jan 27, 2023

Study Type

INTERVENTIONAL

Conditions

Anxiety Depression Depression Anxiety Depressive Symptoms Anxiety Disorders Mood Disorders

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

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 Criteria7

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.

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.

BEHAVIORAL-RxWell

Treatment as usual