Shared Decision Making for Prescription Opioids After Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Management and Opioid Usage Measured by Telephone Questionnaire
研究概览
简要总结
The specific aim of this study is to use a shared decision making tool to allow women who have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will be prescribed at discharge, within a range from 0-40 tablets. The study investigators will document additional information from medical record abstraction (age, race/ethnicity, medical and obstetrical conditions, previous opioid use, date of CD, indication for CD, anesthetic management during CD, duration and complications of CD, length of stay, pain medication use and pain scores on each postoperative day between CD and discharge). The investigators will then follow up with the participants by telephone at two weeks after discharge to assess the amount of opioid used, frequency of prescription refill, disposition of unused medication, and participant satisfaction with their post-cesarean pain control. The investigators hypothesize that the use of a shared decision making tool will decrease the amount of opioid prescribed while still providing participants with satisfactory pain control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postpartum women who underwent a cesarean delivery at MGH
排除标准
- •Non-native English speakers (identified in LMR as "non-English speaking" or "requires interpreter")
- •Women with a history of chronic opioid abuse (identified in LMR as "opioid abuse" or "narcotic abuse")
- •Chronic pain on opioids (identified in LMR as "chronic pain" or "chronic narcotic use")
- •Women on methadone or buprenorphine for treatment of opioid addiction (identified from their medication list in the LMR)
- •Women with impaired decision-making abilities
- •Women hospitalized for > 7 days related to CD
- •Minors (<18 years old)
- •Women being prescribed an opioid other than oxycodone during their postpartum hospitalization (identified from the MAR and discussion with rounding providers)
- •Women with contraindications to taking acetaminophen or NSAIDs
研究组 & 干预措施
Post-cesarean delivery mothers
- Identify eligible women on post-operative day 3. A physician member of the study team will approach participants with study information and consent forms.
- After informed consent is obtained, the participant will be taken through a 10 minute shared decision making session (intervention). The participant will then have the opportunity to ask questions, following which they will indicate the number of prescription opioid tablets to be discharged with (primary outcome)
- The next contact will be at two weeks after discharge, at which time a member of the study team will contact the participant and administer a brief telephone survey with questions pertaining to perceived pain over time, pain management methods, opioid/pain medication consumption/disposal, and satisfaction with postoperative pain control.
- A chart review will be performed by physicians in the research group on participants to gather information on demographics, indications for surgery, etc.
干预措施: Prescribed opioids (Other)
结局指标
主要结局
Pain Management and Opioid Usage Measured by Telephone Questionnaire
时间窗: Within 2 weeks postpartum
Outpatient opioid selection and use after discharge
次要结局
未报告次要终点
研究者
Brian Bateman
MD, MSc
Massachusetts General Hospital