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

Conditions

• Anxiety
• Anxiety Depression
• Anxiety Disorders
• Depression
• Depressive Symptoms
• Mood Disorders

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• +RxWell — BEHAVIORAL
  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. Subjects enrolled after 01DEC25 were unable to download the RxWell application because it was removed from the app store. To avoid disruption, direct access to the RxWell application was replaced with a 30-minute, directed, telemedicine, health coaching session, on at least 2 occasions prior to surgery.
• -RxWell — BEHAVIORAL
  Treatment as usual

Study Details

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

Key Dates

Start date

Jan 27, 2023

Status verified

Jun 2026

Primary completion

Dec 1, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Control
  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
• Experimental: Intervention: RxWell
  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.
• No Intervention: Control (screen failures)
  We will collect data on patient outcomes for patients that did not meet criteria for the RxWell intervention.

Primary Outcome Measure

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

Central Contacts

• Ata Murat Kaynar, MD, MPH
  412-383-3463
  [email protected]
• Carly Riedmann, MPH
  412-623-4147
  [email protected]

Locations (3)

Find similar trials in Monroeville, PA

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