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临床试验/NCT07217002
NCT07217002进行中(未招募)不适用

Reducing Antibiotic Use by Implementation of Stewardship in Primary and Urgent Care

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2025年2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
进行中(未招募)
入组人数
420
试验地点
1
主要终点
Antibiotic Prescribing Rates for Acute Respiratory Tract Infections (ARTIs)

研究概览

简要总结

The goal of this project is to reduce unnecessary antibiotic use for children with ARTIs (Acute Respiratory Tract Infections) by implementing "outpatient antibiotic stewardship" across the Children's Hospital of Philadelphia (CHOP) Primary and Urgent Care Network to:

  1. Reduce unnecessary antibiotic prescribing for the most common infections in children.
  2. Reduce unnecessary a) broad-spectrum and b) longer-course antibiotic therapy for ear infections, Strep throat, sinus infections, and pneumonia.

详细描述

Children often receive antibiotics for acute respiratory tract infections (ARTIs) which are caused by viruses, such as the common cold. However, antibiotics cannot treat viruses. Using antibiotics when they are not needed can cause harm - including side effects like rashes, vomiting and diarrhea - and can make it harder for the antibiotics to work when they are needed to treat infections caused by bacteria. For ARTIs caused by bacteria - like ear infections, sinus infections, strep throat or pneumonia - narrow-spectrum antibiotics are the best choice. This is because narrow-spectrum antibiotics target only the harmful bacteria, while "broad-spectrum" antibiotics target additional bacteria than can be helpful for the body. For many of these infections, it is also better to use shorter courses of antibiotics (such as five days) instead of longer courses (such as 10 days). Research studies have shown clearly that shorter courses and narrow-spectrum antibiotics cure infections just as well as longer courses and broad-spectrum antibiotics, but with fewer side effects.

Over two years, the project team will use proven strategies to ensure that children get the right antibiotics for the right amount of time. During this time, all pediatric doctors and nurse practitioners in this large, diverse network will receive:

  1. Online education about proper antibiotic prescribing.
  2. Regular feedback on how their antibiotic prescribing and group A strep testing compares to their peers and to professional guidelines.
  3. Tools in the electronic health record to make it easy to prescribe the right antibiotics.
  4. Yearly, live hybrid in-person and online educational sessions

The project team will determine how well this program works by measuring:

  1. How often antibiotics are prescribed to children with ARTIs.
  2. How often children with bacterial ARTIs (ear infections, sinus infections, strep throat and pneumonia) get the right antibiotic choice and right number of antibiotic days.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •All children ages 6 months to 12 years seen at CHOP primary care network and CHOP Urgent Care with ARTI diagnoses (viral diagnoses or AOM, CAP, sinusitis, strep pharyngitis) Exclusion
  • •Severe immunocompromised status OR tracheostomy dependence
  • •Children with other bacterial infection diagnoses

排除标准

  • 未提供

研究组 & 干预措施

CHOP Primary Care Providers

Providers at all 30 primary care practice offices and 4 urgent care offices that include physicians and Advanced Practice Provider (APPs) including Nurse Practitioners (NPs) and Physicians Assistants (PAs).

干预措施: Clinical Decision Support (Other)

CHOP Primary Care Providers

Providers at all 30 primary care practice offices and 4 urgent care offices that include physicians and Advanced Practice Provider (APPs) including Nurse Practitioners (NPs) and Physicians Assistants (PAs).

干预措施: Online Educational Modules (Other)

CHOP Primary Care Providers

Providers at all 30 primary care practice offices and 4 urgent care offices that include physicians and Advanced Practice Provider (APPs) including Nurse Practitioners (NPs) and Physicians Assistants (PAs).

干预措施: Prescribing Feedback Reports (Other)

CHOP Primary Care Providers

Providers at all 30 primary care practice offices and 4 urgent care offices that include physicians and Advanced Practice Provider (APPs) including Nurse Practitioners (NPs) and Physicians Assistants (PAs).

干预措施: Live, hybrid in-person and online educational sessions (Other)

结局指标

主要结局

Antibiotic Prescribing Rates for Acute Respiratory Tract Infections (ARTIs)

时间窗: From start of implementation ramp up period to end of year 2 implementation

ARTIs as measured by overall rates of prescribing an antibiotic during clinic visits for an acute respiratory tract infection (URI) diagnosis, including both bacterial and viral URIs using the EHR (electronic health record). Goal is that antibiotics are prescribed at 40% or fewer ARTI visits. The optimal proportion of ARTI visits that should be associated with an antibiotic prescription is unknown. Baseline prescribing rates for antibiotics in the Network ranges from 34-61%. The target 40% rate is currently achieved by 10% of our practices with the lowest antibiotic prescribing.

Change in overall optimal antibiotic prescribing rates for all bacterial ARTI encounters

时间窗: From start of implementation ramp up period to end of year 2 implementation

Changing overall antibiotic prescribing rates as measured by a composite of 1) narrow antibiotic selection and 2) shortest effective duration as a proportion of all antibiotics prescribed for each of the target diagnoses: Acute otitis media, Group A streptococcal pharyngitis, Acute sinusitis, and Pneumonia using EHR (electronic health record) data. This metric combines both narrow-spectrum antibiotic choice and optimal durations of therapy to comprehensively evaluate optimal antibiotic prescribing. At least 90% of antibiotics prescribed for ARTI are for optimal short duration and narrow spectrum antibiotics

Broad- versus Narrow-Spectrum Antibiotic Prescribing

时间窗: From start of implementation ramp up period to end of year 2 implementation

Broad vs. Narrow-Spectrum antibiotic prescribing as measured by rates of broad-spectrum antibiotics as a proportion of all antibiotics prescribed within each of these diagnoses using the EHR (electronic health record): * acute otitis media * Group A streptococcal pharyngitis * acute sinusitis * pneumonia At least 90% of antibiotics prescribed for ARTI are for optimal narrow spectrum antibiotics.

Shortest Effective Duration Antibiotic Prescribing

时间窗: From start of implementation ramp up period to end of year 2 implementation

Shortest effective duration measured by rates of prescribing the shortest effective duration of antibiotics as a proportion of all antibiotics prescribed within each of these diagnoses: * acute otitis media * Group A streptococcal pharyngitis * acute sinusitis * pneumonia At least 90% of antibiotics prescribed for ARTI are for the shortest effective duration of antibiotics. Optimizing durations of therapy will reduce overall antibiotic days and, therefore, decrease the overall antibiotic burden for children with ARTIs.

次要结局

  • Group A Strep Testing(From start of implementation ramp up period to end of year 2 implementation)
  • Treatment failure or modification 14 days(14 days)
  • Antibiotic-associated adverse events (AEs) within 7 days of completing antibiotics(From index visit to 7 days of completing antibiotics)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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