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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA061414-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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 |
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| Intervention: RxWell | Experimental | 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. |
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| Control (screen failures) | No Intervention | We will collect data on patient outcomes for patients that did not meet criteria for the RxWell intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| +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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | POD 1 to Week 4 Post-Op |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Post-Op Month 3 |
| Pain at Rest |
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Inclusion Criteria for the RXWell Study:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ata Murat Kaynar, MD, MPH | Contact | 412-383-3463 | kaynarm@upmc.edu | |
| Carly Riedmann, MPH | Contact | 412-623-4147 | riedmannca@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ata Murat Kaynar, MD, MPH | UPMC Department of Anesthesiology and Perioperative Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC East | Recruiting | Monroeville | Pennsylvania | 15146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37946291 | Derived | Kaynar AM, Lin C, Sanchez AG, Lavage DR, Monroe A, Zharichenko N, Strassburger M, Saucier K, Groff YJ, Klatt BA, O'Malley MJ, Szigethy E, Wasan AD, Chelly JE. SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery. Trials. 2023 Nov 9;24(1):715. doi: 10.1186/s13063-023-07634-0. |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| -RxWell | Behavioral | Treatment as usual |
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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. |
| Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7 |
| 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. | Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7 |
| 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. | Post-Op 1 Month, Post-Op 3 Months |
| UPMC Shadyside | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| UPMC Passavant | Recruiting | Pittsburgh | Pennsylvania | 15237 | United States |
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