Clinical trial NCT05658796: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mood Disorders
Anxiety
Depressive Symptoms
Depression
Anxiety Disorders
Anxiety Depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2022-12-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

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.

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.

Primary outcomes:
measure: Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg)
timeFrame: POD 1 to Week 4 Post-Op
Secondary outcomes:
measure: Opioid prescription refills by 3 months
timeFrame: Post-Op Month 3
measure: Pain at Rest
timeFrame: Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7
measure: Pain with Movement
timeFrame: Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7
measure: Persistent Opioid Use
timeFrame: Post-Op 1 Month, Post-Op 3 Months
Other outcomes:
Locations:
city: Monroeville
country: United States
facility: UPMC East
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Passavant
state: Pennsylvania
Study officials:
affiliation: UPMC Department of Anesthesiology and Perioperative Medicine
name: Ata Murat Kaynar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: