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

University of Pittsburgh

Status: Enrolling

Conditions: Depressive Symptoms; Anxiety Depression; Depression; Anxiety Disorders; Anxiety; Mood Disorders

Treatments: Behavioral: -RxWell; Behavioral: +RxWell

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05658796

STUDY21120053

R21DA061414-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Control

Active Comparator group

Description:

No intervention (No RxWell). Subjects will receive standard of care and education regarding potential resources for anxiety and depression. Subjects will complete questionnaires via REDCap assessing primary and secondary outcomes

Treatment:

Behavioral: -RxWell

Intervention: RxWell

Experimental group

Description:

RxWell Intervention. Subjects will receive standard of care and digital cognitive behavioral intervention by using the application RxWell. Subjects will complete questionnaires via REDCap assessing primary and secondary outcomes and will complete GAD-7 (Generalized Anxiety Disorder Scale) and PHQ-8 (Patient Health Questionnaire for Depression) every 2 weeks within the RxWell application.

Treatment:

Behavioral: +RxWell

Control (screen failures)

No Intervention group

Description:

We will collect data on patient outcomes for patients that did not meet criteria for the RxWell intervention.