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

Official title

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

Overview

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

Detailed 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.

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 acces
• Behavioral -RxWell
  Treatment as usual

Primary outcome measures

• Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg) [Time frame: POD 1 to Week 4 Post-Op]

Secondary outcome measures (4)

• Opioid prescription refills by 3 months [Time frame: Post-Op Month 3]
• Pain at Rest [Time frame: Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7]
• Pain with Movement [Time frame: Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7]
• Persistent Opioid Use [Time frame: Post-Op 1 Month, Post-Op 3 Months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 3 centers

• UPMC East — Monroeville
• UPMC Shadyside — Pittsburgh
• UPMC Passavant — Pittsburgh

Publications

• Kaynar AM, Lin C, Sanchez AG, Lavage DR, Monroe A, Zharichenko N, Strassburger M, Saucier K, Groff YJ, Klatt BA, O'Malley MJ, Szigethy E, Wasan AD, Chelly JE. SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery. Trials. 2023 No PMID 37946291

Identifiers

NCT: NCT05658796 · STUDY21120053 · R21DA061414-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗