24-hour Oral Morphine Equivalent Based Opioid Prescribing After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Prescribed Post-discharge Opioids
研究概览
简要总结
The investigators will utilize the electronic health record to individualize pain therapy in surgical patients after hospital discharge using last 24-hour opioid intake as the decision variable for the amount of opioid pain pills prescribed. The preliminary data indicate that current opioid prescription practice after surgery follows a "one size fits all" pattern. In-hospital opioid use 24 hours prior to discharge serves as a strong indicator to correctly estimate needs for analgesic medications at home. The investigators will test the hypothesis that this prescription estimation tool will enable providers to write need-based prescriptions based on each patient's' 24-hour prior-to-discharge opioid use. The investigators will test this tool prospectively for patients after Cesarean section who are anticipated to use about half or less of the usually prescribed amount of opioid pain pills after discharge randomized equally to prescription tool intervention or no intervention (prescription as usual).
详细描述
Prescription opioid overdose has emerged as a leading cause of death in the general population. Opioid-based therapy represents a corner-stone of post-operative pain management. With increasing emphasis on robust pain therapy, sales of opioid medications have increased four-fold in the last decade. Parallel to this rise, opioid-associated deaths have also quadrupled. The investigators have shown that long-term opioid use occurs in up to 22% of patients following surgery. Over-prescribed opioids after surgery can create a reservoir of opioids that become available for non-medical use. Effective strategies to maximize non-opioid pain therapy and to limit such a reservoir are lacking. Thus, there is an urgent need to individualize post-operative pain therapy and reduce reliance on opioids.
Converting knowledge on actual need for opioid pain medications after surgery into tangible benefits can prevent over-prescription of opioids that become available for non-medical use. The objective of this study is to prescribe pain medications after surgery in a patient-centered fashion. The investigators will use the average amount of opioid medications (in oral morphine equivalents - OME) taken in the last 24 hours prior to discharge to inform and design a clinical decision support tool. This tool will reduce the amount of opioid medications prescribed while maintaining patient post-operative pain control. The calculated "last 24 hour OME dose" will be applied to generate a recommendation for the prescription of a cumulative opioid dose that will be shared with the provider when the post-discharge pain medication is made, e.g. via displaying the last 24-hour opioid use in the electronic health record (EHR). The rationale is that testing of such a decision-making tool will lay the groundwork to translate the findings of this project into more secure and efficient opioid prescribing practices to a system-wide level. Upon completion, the investigators expect to have developed an effective decision-making tool to help providers estimate required pain medication following patient discharge.
The investigators will perform a randomized clinical trial (RCT) of an Electronic Health Record (EHR)-based recommendation to prescribe opioids at discharge according to the recorded last 24-hour inpatient use according to current recommendations and evaluate its effect on the amount of opioids prescribed as well as pain control after discharge.
Using the University of Colorado Hospital Epic/Clarity database, the investigators will continuously identify all patients who underwent Cesarean section surgery at University Hospital. Patients will be approached regarding interest in the study prior to hospital discharge.A trained Professional Research Assistant or other provider will explain the study and obtain informed consent from prospective participants. After consent, demographics and the best contact information will be collected from those enrolled patients who indicate they are interested in completing the surveys after their hospital discharge.
The investigators expect 44 patients to complete all four weekly surveys and define the intent-to-treat sample as patients who complete one or more surveys (providing at least one observation to be used in analyses). To conservatively allow for increased variability due to attrition, 54 patients will be randomized equally electronically to intervention (prescription tool) or no intervention (prescription as usual). The investigators will use an electronic randomization scheme created so that the principal investigator and statistician can remain blind to assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
The investigators will use an electronic randomization scheme created so that the principal investigator and statistician can remain blind to assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages at least 18 years of age having undergone Cesarean section surgery at the University of Colorado Hospital are eligible.
- •Willingness to complete weekly surveys for 4 weeks after discharge.
- •Anticipated to need half or less of the usually prescribed amount of opioids based on the amount of opioids taken in the last 24 hours prior to the opioid medication being written for discharge (only patients who took 22.5 MME or less opioids in the last 24 hours prior to the day of discharge will be eligible for this study).
排除标准
- •Patients under the age of 18 years.
- •Patients returning to institutional settings (e.g. prison, jail, mental health facility).
- •Pregnant women (patients will be approached after their C-section).
- •Decisionally challenged patients.
- •Blind or illiterate patients.
- •Based on prior research factors such as emergency status, prior opioid use, repeat vs primary C-section, and associated procedures were not associated with post-discharge opioid use once the investigators adjusted for last-24 hour inpatient opioid use. Hence, these patients will not be excluded.
- •Inclusion and exclusion criteria (including the amount of opioids taken in the last 24 hours prior to discharge) will be evaluated in the morning in patients scheduled to be discharged later that day.
结局指标
主要结局
Prescribed Post-discharge Opioids
时间窗: Date of admission to the hospital up to 60 days after the date of hospital discharge.
Prescribed post-discharge opioid doses in oral morphine equivalents from the electronic health record (EHR).
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 3(Three weeks after hospital discharge date.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 4(Four weeks after hospital discharge date.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 2(Two weeks after hospital discharge date.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 1(One week after hospital discharge date.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 2(Two weeks after hospital discharge date.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 1(One week after hospital discharge date.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 3(Three weeks after hospital discharge date.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 4(Four weeks after hospital discharge date.)
