跳至主要内容
临床试验/NCT06027593
NCT06027593已完成不适用

Using Electronically Derived AutoMated RePOrts of Appropriate Antibiotic Use to Inform SteWardship IntERventions

Children's Hospital of Philadelphia4 个研究点 分布在 1 个国家目标入组 26,139 人开始时间: 2022年10月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26,139
试验地点
4
主要终点
Guideline-concordant Antibiotic Use for Children With Acute Otitis Media

研究概览

简要总结

The main goal of this study is to use automated electronic reports to assess and improve guideline-concordant antibiotic use for:

1) adult inpatients with community-acquired pneumonia; 2) pediatric inpatients with community-acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media.

详细描述

Antibiotic stewardship has been shown to improve patient outcomes, decrease adverse events, and decrease antibiotic resistance. This group of investigators previously partnered with collaborators at the Centers for Disease Control and Prevention and conducted relevant pilot work in developing and validating electronic indicators of inappropriate antibiotic prescribing for 8 conditions, amongst which are the four conditions of interest in this study: adult inpatients with community-acquired pneumonia; pediatric inpatients with community-acquired pneumonia; adult outpatients with acute pharyngitis; and pediatric outpatients with acute otitis media. Methods were developed to generate automatic, routine reports to identify elements of inappropriate antibiotic use including; 1) the decision to initiate antibiotic therapy (pharyngitis and acute otitis media only); 2) the choice of antibiotic agent; and 3) the duration of antibiotic use.

The purpose of this project is to assess the impact of these developed electronic indicators on supporting antibiotic stewardship efforts to improve the appropriateness of antibiotic use, as well as the acceptability and feasibility of delivering these reports to prescribers. The investigators aim to:

  1. Refine and validate indicators of appropriate antibiotic use by utilizing Electronic Health Record data, including International Classification of Diseases version 10 codes, medications, laboratory data, co-morbid medical conditions, site of care, clinical documentation, prior hospitalizations, and medication exposure. The researchers will validate the definitions of the various conditions and appropriateness captured electronically with a manual chart review of clinical documentation.
  2. Implement a scalable and sustainable antimicrobial stewardship feedback report-based intervention for these four conditions informed by a rapid user-centered design process.
  3. Track the impact of the stewardship interventions and report to key stakeholders, including prescribers.
  4. Create a publicly available toolkit based on the findings of this project that includes: (i) analytic tools and resources for using the automated reports of key indicators to target stewardship interventions and (ii) an implementation guide to inform the application of automated reports to stewardship in the inpatient and outpatient settings.

If proven effective, these electronic health record-based approaches hold the promise to greatly enhance the effectiveness and efficiency of antimicrobial stewardship initiatives.

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
否

入选标准

  • •Patient Inclusion Criteria:
  • •Diagnosis of one of four conditions based on ICD-10 diagnostic codes.

排除标准

  • •Presence of specific complex chronic conditions
  • •Use of immunocompromising medications
  • •Transfer from another health facility.
  • •Clinician Inclusion Criteria:
  • •Prescribing clinicians (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) at one of the participating outpatient practices or inpatient units.
  • •Age ≥ 18 years old
  • •Employed by one of the participating sites
  • •Clinician Exclusion Criteria:
  • •Volunteers or other non-employee hospital staff
  • •Limited English proficiency

研究组 & 干预措施

Pre-Intervention: Patients diagnosed with conditions of interest during study period

No Intervention

Four population groups were included in the pre-intervention data: 1) adult inpatients with community acquired pneumonia; 2) pediatric inpatients with community acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media

Post-Intervention: Patients diagnosed with conditions of interest during study period

Other

Four population groups were included in the post-intervention data: 1) adult inpatients with community acquired pneumonia; 2) pediatric inpatients with community acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media

干预措施: Quasi experimental intervention (Other)

结局指标

主要结局

Guideline-concordant Antibiotic Use for Children With Acute Otitis Media

时间窗: Pre-intervention and post-intervention, up to 2 years

Count of participants with acute otitis media with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with acute otitis media with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with pediatric acute otitis media who were prescribed antibiotics to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

Guideline-concordant Antibiotic Use for Adults With Community-acquired Pneumonia

时间窗: Pre-intervention and post-intervention, up to 2 years

Count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

Guideline-concordant Antibiotic Use for Children With Community-acquired Pneumonia

时间窗: Pre-intervention and post-intervention, up to 2 years

Count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with pediatric community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

Guideline-concordant Antibiotic Use for Adults With Pharyngitis

时间窗: Pre-intervention and post-intervention, up to 2 years

Count of participants with pharyngitis with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with pharyngitis with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with pharyngitis to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

次要结局

  • Guideline-concordant Antibiotic Duration for Adult Pharyngitis(Pre-intervention and post-intervention, up to 2 years)
  • Guideline-concordant Antibiotic Duration for Pediatric Community Acquired Pneumonia(Pre-intervention and post-intervention, up to 2 years)
  • Guideline-concordant Antibiotic Choice Adult Pharyngitis(Pre-intervention and post-intervention, up to 2 years)
  • Guideline-concordant Antibiotic Choice for Adults Hospitalized With Community Acquired Pneumonia(Pre-intervention and post-intervention, up to 2 years)
  • 28-day Community Acquired Pneumonia-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Children(28 days)
  • 28-day Readmissions for Pediatric Community Acquired Pneumonia(28 days)
  • Guideline-concordant Antibiotic Duration for Adults Hospitalized With Community Acquired Pneumonia(Pre-intervention and post-intervention, up to 2 years)
  • 30-day Community Acquired Pneumonia-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Adults(30 days)
  • 30-day Readmissions for Community Acquired Pneumonia in Adults(30 days)
  • Guideline-concordant Antibiotic Choice for Pediatric Community Acquired Pneumonia(Pre-intervention and post-intervention, up to 2 years)
  • Guideline-concordant Decision to Prescribe Antibiotics for Adult Pharyngitis(Pre-intervention and post-intervention, up to 2 years)
  • 30-day Pharyngitis Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Adults(30 days)
  • 30-day Deep Neck Space Infection Admission(30 days)
  • Guideline-concordant Decision to Prescribe Antibiotics for Pediatric Acute Otitis Media(Pre-intervention and post-intervention, up to 2 years)
  • Guideline-concordant Antibiotic Choice for Pediatric Acute Otitis Media(Pre-intervention and post-intervention, up to 2 years)
  • Guideline-concordant Antibiotic Duration for Pediatric Acute Otitis Media(Pre-intervention and post-intervention, up to 2 years)
  • 28-day Acute Otitis Media-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care)(28 days)
  • 28-day Mastoiditis or Intracranial Infection Admissions(28 days)
  • Guideline-concordant Decision to Not Prescribe Antibiotics for Pediatric Acute Otitis Media(Pre-intervention and post-intervention, up to 2 years)
  • Guideline-concordant Decision to Not Prescribe Antibiotics for Adult Pharyngitis(Pre-intervention and post-intervention, up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验