Telemedicine-delivered Digital Cognitive Behavioral Intervention to Decrease Post-operative Opioid Use Among Patients Undergoing Total Knee or Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg)
研究概览
简要总结
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
详细描述
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.
- 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.
- Determine the impact of RxWell-associated improvements in anxiety, depression, and catastrophizing on postoperative outcomes with a special focus on resources utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for the RXWell Study:
- •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
排除标准
- •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.
- •Patients needing immediate care will be referred to psychiatrists and primary team.
研究组 & 干预措施
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
干预措施: -RxWell (Behavioral)
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.
干预措施: +RxWell (Behavioral)
Control (screen failures)
We will collect data on patient outcomes for patients that did not meet criteria for the RxWell intervention.
结局指标
主要结局
Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg)
时间窗: 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).
次要结局
- Persistent Opioid Use(Post-Op 1 Month, Post-Op 3 Months)
- Opioid prescription refills by 3 months(Post-Op Month 3)
- Pain at Rest(Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7)
- Pain with Movement(Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7)
研究者
Ata Murat Kaynar
Professor
University of Pittsburgh