Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
研究概览
详细说明
This study will be a randomized controlled trial for primary, unilateral total knee arthroplasty (TKA) patients at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center to determine the impact of using a SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7.
The SDA includes factual information about the World Health Organization pain ladder, the 0-10 NRS pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in TKA patients. The SDA has been developed by the principal investigator solely for the purpose of this study.
Patients will be enrolled on postoperative day 0 or 1 and randomized to intervention or control groups. The intervention group will view the SDA slides on the study iPad. SDA viewing will be guided by the research assistant, who will read a pre-written script as each slide is viewed. Following the guided viewing of the SDA, subjects in the intervention group will have the opportunity to ask questions to the research assistant to confirm their comprehension of the presented facts. The control group will receive no intervention and will receive standard of care and standard discharge prescriptions. The intervention group subjects will choose the number of opioid pills they wish to include in their discharge opioid prescription (anywhere from 0 to the maximum allowable as determined by clinical practice and/or state law).
Daily analgesic intake, adverse effects and numeric rating scale (NRS) pain scores will be collected and analyzed.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Naida Cole, MD
- 电话号码：9176576692
- 邮箱：nmcole@bsd.uchicago.edu
研究联系人备份
- 姓名：Laura Mendez, MD
- 电话号码：8574004065
- 邮箱：lmendez-pino@bwh.harvard.edu
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60637
- 招聘中
- University of Chicago Medical Center
-
接触：
- Naida Cole, MD
- 邮箱：nmcole@bsd.uchicago.edu
-
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Massachusetts
-
Boston、Massachusetts、美国、02115
- 招聘中
- Brigham and Women's Hospital
-
接触：
- Jose Zeballos, MD
- 邮箱：jzeballos@bwh.harvard.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Primary unilateral TKA under spinal anesthesia at Brigham & Women's Faulkner Hospital (BWFH), Brigham and Women's Hospital or University of Chicago Medical Center by a participating surgeon
- >18 years of age
Planned discharge with the typical analgesic medications prescribed at discharge:
- standing around-the clock Tylenol with or without an NSAID
- tramadol PRN
- hydromorphone (dilaudid) or oxycodone PRN
Exclusion Criteria:
- Diagnosis of dementia
- <18 years old
- Contraindication or allergy to opioids
- Contraindication or allergy to Tylenol
- Contraindication or allergy to gabapentin
- History of substance use disorder
- Preoperative pain requiring a >1-month prescription for >/=45 daily MMEs
- 4 or more preoperative analgesic prescriptions
- Hospital admission >1 day
- Discharge to a skilled nursing facility/inpatient rehabilitation center
- Non-English speaking patients
- Requirement for general anesthesia intra-operatively
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Decision Aid
The shared decision aid (SDA) includes factual information about the World Health Organization pain ladder, the 0-10 numeric rating score pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in total knee arthroplasty patients.
Subjects in the decision aid group will view the decision aid and have the opportunity to participate in shared decision-making for their discharge opioid prescriptions.
|
The intervention group will receive a shared decision-making intervention including a decision aid and conversation with a study investigator.
The intervention group will have the opportunity to choose the number of opioid pills they receive at discharge from hospital after total knee arthroplasty.
|
|
无干预：Control
Subjects in the control group will undergo standard care and discharge practices.
Baseline pain and psychosocial factors will be documented as well as postoperative pain and analgesic consumption.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Leftover opioid pills
大体时间：30 days postoperatively
|
30 days postoperatively
|
|
Average 0-10 NRS pain score
大体时间：postoperative day 7
|
postoperative day 7
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Quantity of opioid consumed
大体时间：30 days postoperatively
|
30 days postoperatively
|
|
Satisfaction with pain management
大体时间：30 days postoperatively
|
30 days postoperatively
|
|
Quantity of opioid pills prescribed
大体时间：postoperative day 1 at hospital discharge
|
postoperative day 1 at hospital discharge
|
合作者和调查者
调查人员
- 首席研究员：Naida Cole, MD、University of Chicago
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2020P002342
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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