Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Patient-Reported Pain Scores
研究概览
简要总结
The investigators will compare two physician behaviors for managing pain in patients with IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard of care at the institution in which the study will be performed. The PROACTIVE strategy is an IBD-specific analgesic orderset (built into our EMR and approved by the institution's Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional "reactive" analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE IBD-specific analgesic orderset consists of medications which have evidence for use in IBD-related pain. This orderset is an educational guide, it does not force any order. The reactive prescribing habits could contain an array of pain medications depending on what the provider wants to prescribe.
Aims:
Aim 1: To assess whether there is a difference in pain scores or functional activity among hospitalized patients with IBD between reactive vs proactive physician behaviors.
Aim 2: To assess whether there is a difference in inpatient opioid-prescribing between reactive vs proactive physician behaviors.
Aim 3: To assess whether there is a difference in health care utilization, including length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.
详细描述
Prospective, investigator-blinded, single-institution randomized-control trial . Consecutive adult patients with IBD (Crohn's disease or ulcerative colitis) admitted to the hospital will be screened for eligibility, and eligible patients will be approached and consented to participate. Subjects will be randomized to receive the P.A.I.N.-Sparing bundle or usual care. Patient randomization will be stratified by provider to avoid bias, using a web-based in-house system (RANDI3). Subjects will also be provided with a fitness tracker (Fitbit(R)) to measure functional status during their hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The primary investigators will be blinded, as will the computer programmers who collect the data.
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
- •Adults with confirmed IBD diagnosis
- •Admitted for primary IBD-related sign or symptom
排除标准
- •Admitted for primary non-IBD complaint
- •Surgery in the last 30 days
- •Alternative (non-IBD) GI diagnosis determined
- •Pregnancy
结局指标
主要结局
Patient-Reported Pain Scores
时间窗: Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.
Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))
次要结局
- Healthcare Utilization(From hospital admission until hospital discharge, typically 7 days.)
- Opioid-Consumption(From hospital admission until hospital discharge, typically 7 days.)
- Functional Activity(From hospital admission until hospital discharge, typically 7 days.)
研究者
Gil Melmed
co-Director, Inflammatory Bowel Disease Center, Principal Investigator
Cedars-Sinai Medical Center