Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9,265
- 试验地点
- 51
- 主要终点
- Deimplementation Sustainment
研究概览
简要总结
The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen.
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
- None
入排标准
- 年龄范围
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Population a: Bronchiolitis patients directly observed while not receiving supplemental oxygen ("in room air," for primary trial outcome)
- •Inclusion Criteria:
- •Infants and children 2 months through 23 months old
- •Hospitalized on non-ICU wards participating in the trial
- •Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
- •Primary diagnosis of bronchiolitis in most recent physician progress note
- •Not actively receiving supplemental oxygen ("in room air")
- •Last documented receipt of supplemental oxygen >1 hour prior to direct observational data collection
排除标准
- •Documented apnea or cyanosis during the current illness
- •Extreme prematurity (<28 weeks completed gestation)
- •Cardiac disease
- •Pulmonary hypertension
- •Chronic lung disease
- •Home oxygen requirement
- •Neuromuscular disease
- •Immunodeficiency
- •Severe Acute Respiratory Syndrome Coronavirus 2 (Covid-19 / SARS-CoV-2)-related illness (known or suspected, including multisystem inflammatory syndrome in children multi-system inflammatory syndrome in children (MIS-C)
- •Population b: Bronchiolitis patients directly observed while receiving supplemental oxygen (for underuse evaluation).
- •Inclusion Criteria:
- •Infants and children 2 months through 23 months old
- •Hospitalized on non-ICU wards participating in the trial
- •Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
- •Primary diagnosis of bronchiolitis in most recent physician progress note
- •Actively receiving ≥2 Liters/minute (2L/min) supplemental oxygen or 21% room air flow
- •Exclusion Criteria:
- •Extreme prematurity (<28 weeks completed gestation)
- •Cardiac disease
- •Pulmonary hypertension
- •Chronic lung disease
- •Home oxygen requirement
- •Neuromuscular disease
- •Immunodeficiency
- •Severe Acute Respiratory Syndrome Coronavirus 2 [Covid-19 / SARS-CoV-2 (known or suspected)]
研究组 & 干预措施
Unlearning Only
Includes educational outreach and audit & feedback.
干预措施: Educational Outreach (Behavioral)
Unlearning Only
Includes educational outreach and audit & feedback.
干预措施: Audit & Feedback (unit level) (Behavioral)
Unlearning Only
Includes educational outreach and audit & feedback.
干预措施: Audit & Feedback (real time, individual-level) (Behavioral)
Unlearning + Substitution
Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
干预措施: Educational Outreach (Behavioral)
Unlearning + Substitution
Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
干预措施: Audit & Feedback (unit level) (Behavioral)
Unlearning + Substitution
Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
干预措施: Audit & Feedback (real time, individual-level) (Behavioral)
Unlearning + Substitution
Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
干预措施: Clinical Pathway Integrated into Electronic Health Record (Behavioral)
结局指标
主要结局
Deimplementation Sustainment
时间窗: Data from the baseline phase (approximately 7 months) was compared to data from the sustainment phase (approximately 4 months). Only data from baseline and sustainment phases are used in this calculation.
The primary outcome specified in the protocol is deimplementation sustainment, a "difference in differences" outcome based on statistical comparisons based on pulse oximetry overuse across trial phases and arms. Pulse oximetry overuse is operationally defined as percent of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation). The least metabolized form of the data for pulse oximetry overuse, raw proportions across trial phases and arms, is reported here. Results of the specific analysis used to report the trial's pre-specified primary outcome of deimplementation sustainment is reported in Statistical Analysis 1.
次要结局
- Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Baseline Phase of the Trial(This measure used data from the baseline phase (approximately 7 months).)
- Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Active Deimplementation Phase of the Trial(Data from the active deimplementation phase (approximately 5 months).)
- Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Sustainment Phase of the Trial(Data from the sustainment phase (approximately 4 months).)
- Length of Hospital Stay(Up to 4 years)
- Duration of Oxygen Supplementation(Up to 4 years)