RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty
- Conditions
- DepressionAnxiety DisordersDepressive SymptomsAnxietyAnxiety DepressionMood Disorders
- Interventions
- Behavioral: -RxWellBehavioral: +RxWell
- Registration Number
- NCT05658796
- Lead Sponsor
- University of Pittsburgh
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control -RxWell 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 Intervention: RxWell +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.
- Primary Outcome Measures
Name Time Method Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg) POD 1 to Week 4 Post-Op This outcome will be measured by extracting pain medication data from the electronic health record to determine OME (oral morphine equivalents) (mg) for opioid medications on POD 1 and 2, and weeks 1 and 4 following surgery. This will be recorded for each study arm as mean (SD).
- Secondary Outcome Measures
Name Time Method Persistent Opioid Use Post-Op 1 Month, Post-Op 3 Months This outcome will be measured by the number of participants still using opioids at the timepoints provided in the time frame. This is a binary yes/no response - yes, the subject is using opioids, no the subject is not using opioids and will be abstracted from the medical records.
Opioid prescription refills by 3 months Post-Op Month 3 This outcome will be measured by abstracting the PDMP review from the medical records to determine the number of opioid prescription refills by post-op month 3. This will be counted per patient and each arm will be recorded as a mean (SD).
Pain at Rest Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7 Pain scores will be collected using a numerical rating scale (NRS) in which 0 = no pain at all, and 10 = worst pain imaginable. This outcome will be averaged in each arm and reported as mean (SD) for each timepoint provided in the time frame.
Pain with Movement Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7 Pain scores will be collected using a numerical rating scale (NRS) in which 0 = no pain at all, and 10 = worst pain imaginable. This outcome will be averaged in each arm and reported as mean (SD) for each timepoint provided in the time frame.
Trial Locations
- Locations (3)
UPMC East
🇺🇸Monroeville, Pennsylvania, United States
UPMC Shadyside
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Passavant
🇺🇸Pittsburgh, Pennsylvania, United States