跳至主要内容
临床试验/NCT04178941
NCT04178941已完成不适用

Feasibility Pilot of Audit and Feedback With Educational Outreach to Align Continuous Pulse Oximetry Use in Stable Bronchiolitis With Evidence and Guideline Recommendations

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 1,898 人开始时间: 2019年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,898
试验地点
2
主要终点
Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)

研究概览

简要总结

The primary objective is to measure the feasibility, acceptability, and appropriateness of audit and feedback with educational outreach as a strategy to align continuous pulse oximetry use in stable bronchiolitis patients with evidence and guideline recommendations.

详细描述

Continuous pulse oximetry (SpO2) monitoring has revolutionized detection of oxygen desaturation in operating rooms and other high-risk areas, improving outcomes in those settings. However, research suggests that overuse of continuous SpO2 monitoring in stable children with bronchiolitis who are unlikely to benefit from it is low-value care that places some children at risk of adverse outcomes. Despite national guidelines discouraging continuous pulse oximetry use in stable bronchiolitis patients, 46% of those infants and children are continuously monitored. This pragmatic, prospective, non-randomized, single-arm feasibility pilot will be performed on non-Intensive Care Unit (ICU) hospital units that care for bronchiolitis patients. The primary subjects are hospital staff who order or manage continuous pulse oximetry monitoring for bronchiolitis patients; secondary subjects are patients age 2 through 23 months with a primary diagnosis of bronchiolitis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Primary subjects - Hospital staff
  • Nurses, physicians, physician assistants, nursing assistants, or respiratory therapists
  • Providing care to patients on units included in the study.
  • Secondary subjects - Patients
  • Males or females 8 weeks through 23 months old hospitalized on non-Intensive Care Unit (ICU) wards
  • Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
  • Primary diagnosis of acute bronchiolitis according to hospital chart
  • Not currently requiring supplemental oxygen therapy or nasal cannula flow at an fraction of inspired oxygen in the air (FiO2) of 21% (room air flow)

排除标准

  • Primary subjects - Hospital staff
  • None. Staff may self-exclude by choosing not to interact with the electronic communications and may choose to not attend meetings where the intervention is discussed.
  • Secondary subjects - Patients
  • Premature birth: <28 weeks completed gestation
  • Cyanotic congenital heart disease
  • Pulmonary hypertension
  • Home oxygen or positive pressure ventilation requirement
  • Tracheostomy
  • Neuromuscular disease
  • Immunodeficiency
  • Historical, current, or suspected diagnosis of heart failure, myocarditis, or arrhythmia
  • Historical, current, or suspected diagnosis of Coronavirus disease 2019 (COVID-19)

结局指标

主要结局

Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)

时间窗: 1 month after intervention

The participant rates the feasibility of the intervention based on this statement: "Data feedback about our use of continuous pulse oximetry in patients with bronchiolitis is easy to implement." Data was only collected from the "STAFF SURVEYED - Intervention (Single Arm)" Arm/Group for this Outcome Measure.

Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM)

时间窗: 1 month after intervention

The participant rates the acceptability of the intervention based on this statement: "I like the data feedback." Data was only collected from the "STAFF SURVEYED - Intervention (Single Arm)" Arm/Group for this Outcome Measure.

Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM)

时间窗: 1 month after intervention

The participant rates the appropriateness of the intervention based on this statement: "Data feedback about our use of continuous pulse oximetry in bronchiolitis seems like a good match for our non-ICU floors that care for bronchiolitis." Data was only collected from the "STAFF SURVEYED - Intervention (Single Arm)" Arm/Group for this Outcome Measure.

次要结局

  • Hospital-level Percentage of Patients Continuously Monitored When Not Receiving Supplemental Oxygen(4 months)
  • Sensitivity of the Presence of Electronic Health Record (EHR) Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis. Sensitivity is Also Referred to as the "True Positive Rate."(4 months)
  • Specificity of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis. Specificity is Also Referred to as the "True Negative Rate."(4 months)
  • Positive Predictive Value (PPV) of the Presence of Electronic Health Record Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis.(4 months)
  • Negative Predictive Value of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis.(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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