Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 711
- 试验地点
- 2
- 主要终点
- Cumulative Weekly Opioid Intake After Discharge
研究概览
简要总结
Following inpatient surgery, more than 80% of patients are prescribed opioids for use after discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize non-opioid therapy. The proposed study seeks to test a provider-facing decision support tool and a participant-facing smartphone app to reduce the amount of opioids prescribed and taken following discharge, while ensuring effective treatment of pain after surgery. Adult participants with smart phones having had inpatient surgery requiring at least over-night hospitalization with anticipated discharge to home will be randomized to one of the two groups. Study measurements will include self-reported cumulative amounts of opioids taken after discharge, non-opioid analgesic taken, prescribed post-discharge opioid doses in morphine milligram equivalents (MME), pain intensity and pain interference scores (PROMIS), need for additional opioid prescriptions within one-month post-discharge, as well as any self-reported disposal of leftover medications.
详细描述
Prior to discharge from the hospital, patients will be approached regarding interest in the study with an introductory letter that describes the content and purpose of the study. Following informed consent, participants will be randomized to receive the consumer health informatics app (UControlPain) versus provision of an app with only data collection function (no educational components). Randomization will be implemented via REDCap by the study coordinators. Further, information on which type of app was installed will not be shared with providers or participants.
During the second half of the trial, a provider-facing electronic decision support tool will be activated. This will create a 2:2 design to test the provider-facing tool. Four arms will be described: the UControlPain App with Only data collection, the UControlPain Educational app only, the UControlPain App and provider-facing tool, and the UControlPain App with only data collection function and provider-facing tool. Once half of the subjects are enrolled, the provider-facing tool will be turned on.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Randomization to the participant facing app will be implemented via REDCap. There will be no randomization in regard to the provider-facing intervention.The provider-facing intervention will be turned on once half the subjects are enrolled.
入排标准
- 年龄范围
- 19 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19-89 years old
- •Access to a smartphone (iOS or Android)
- •Inpatient surgery requiring at least over-night hospitalization and anticipated discharge to home
排除标准
- •Re-hospitalization within 30 days
- •Unable to read the English language
- •Discharge to a post-acute care facility
- •Contraindications to opioids, acetaminophen, or NSAIDs
- •Long-term opioid therapy (AHRQ definition - opioid use on most days >3 months) prior to surgery
结局指标
主要结局
Cumulative Weekly Opioid Intake After Discharge
时间窗: Baseline (discharge), weekly for four weeks
Opioids reported as taken will be recorded by type of opioid, units, and total amount taken within the first 28 days after hospital discharge. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents (MME).
次要结局
- Pain Assessment-Pain Intensity(Weekly for four weeks after discharge)
- Pain Assessment-Pain Interference(Weekly for four weeks after discharge)
- Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge(Baseline (discharge))
- Number of Participants With Opioids Prescribed From "Day of Discharge + 1" Until 28 Days After Discharge(Baseline (discharge) +1 day until day 28, up to 27 days total)
- Number of Participants Who Disposed of Opioids(Baseline (discharge), weekly for four weeks)