Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
试验速览
- 阶段
- 不适用
- 入组人数
- 142
- 试验地点
- 4
- 主要终点
- Average 0-10 NRS pain score
研究概览
简要总结
This will be a randomized controlled clinical trial in patients who have undergone primary unilateral total knee arthroplasty at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center. Study subjects will receive either a shared decision aid (SDA) about pain management or standard of care at the time of discharge. The impact of the SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7 will be assessed.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Investigators not involved in administering the SDA and data collection will be blinded. The study subject and investigator(s) involved in administering the SDA and collecting outcomes data will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Average 0-10 NRS pain score
时间窗: postoperative day 7
Leftover opioid pills
时间窗: 30 days postoperatively
次要结局
- Quantity of opioid consumed(30 days postoperatively)
- Quantity of opioid pills prescribed(postoperative day 1 at hospital discharge)
- Satisfaction with pain management(30 days postoperatively)
研究者
Naida Margaret Cole
Anesthesiologist
University of Chicago