RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Pittsburgh
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
+RxWell
BehavioralDuring 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
BehavioralTreatment as usual
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: Intervention: RxWellExperimental treatment 1 intervention
Group C: Control (screen failures)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg)
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).
Time frame
POD 1 to Week 4 Post-OpSecondary outcomes
1
Opioid prescription refills by 3 months
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).
Time frame
Post-Op Month 32
Pain at Rest
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.
Time frame
Post-Op Day 1, Post-Op Day 2, and Post-Op Day 73
Pain with Movement
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.
Time frame
Post-Op Day 1, Post-Op Day 2, and Post-Op Day 74
Persistent Opioid Use
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.
Time frame
Post-Op 1 Month, Post-Op 3 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov