SuRxgWell: The Use of RxWell to Minimize the Impact of Mood Disorders on the Recovery of Surgical Patients
Purpose
With the SuRxgWell study, the investigators envision multipronged benefits from this pilot work for the University of Pittsburgh Medical Center (UPMC) Insurance Services Division (ISD) and its members. The RxWell platform is expected 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.
Conditions
- Mood Disorders
- Anxiety
- Depressive Symptoms
- Depression
- Anxiety Disorders
- Anxiety Depression
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
for the SuRxgWell Study: - scheduled for elective orthopedic surgery UPMC Shadyside, Passavant, East and St. Margaret hospitals - high levels of negative affective symptoms on validated PROMIS measures - T-score > or = to 60 on PROMIS Anxiety 4a short form and/or PROMIS Depression 4a short form.
Exclusion Criteria
for the SuRxgWell Study: - undergoing non-elective surgery or secondary arthroplasty - active delirium - neurocognitive impairment - severe intellectual disability - no access to a smart phone or tablet - profound mood disorders requiring immediate intervention such as suicidal ideation - T-score >70 in PROMIS Anxiety 4a short form and/or PROMIS Depression 4a short form.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
Detailed Description
It is being hypothesized that the perioperative (pre-, peri-, and post-operatively) use of the RxWell will help reduce the deleterious impact of established mood disorders on recovery, including: pain and opioid requirement, functional recovery, decreased complications, and reduction in resources utilized such as hospital length of stay, postoperative need for visits, or the use of rehabilitation. The proposal of this pilot study is to investigate the role that MyUPMC could play in detecting preoperative mood disorders in patients undergoing elective surgery and that the use of RxWell could play in reducing the impact of mood disorders on recovery by its involvement pre-operatively, during hospitalization, and after discharge from the hospital. It is established that mood disorders increase peri-operative pain, opioid requirement, and delayed recovery causing an increase in resource utilization. Accordingly, the specific aims are: 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. 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 hip and 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.
