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临床试验/NCT02943551
NCT02943551Unknown不适用

Dialogue Around Respiratory Illness Treatment

Seattle Children's Hospital40 个研究点 分布在 1 个国家目标入组 2,728 人开始时间: 2016年7月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
2,728
试验地点
40
主要终点
Change in rates of overall antibiotic prescribing for all ARTI visits

研究概览

简要总结

Unwarranted use of antibiotics for pediatric acute respiratory tract infections (ARTIs) and use of second-line, broad spectrum antibiotics for bacterial ARTIs has contributed to the rapid development of resistance in many strains of bacteria. Provider-parent communication during pediatric visits for ARTIs strongly influence antibiotic prescribing rates. The overall goal of this study is to develop and test a distance learning quality improvement (QI) program called Dialogue Around Respiratory Illness Treatment - DART. The DART program aims to improve provider communication practices and treatment decisions during pediatric ARTI visits, with the ultimate goal being to decrease rates of antibiotic prescribing for these illnesses in children.

详细描述

The specific aims of the study are:1) to test the DART program's effectiveness on a) overall antibiotic prescribing rates for all pediatric ARTIs and b) first-line antibiotic prescribing rates for bacterial ARTIs (acute otitis media, Group A Streptococcal pharyngitis, and sinusitis), 2) to test the DART program's effectiveness in changing providers' communication practices during ARTI visits, 3) to determine visit-specific satisfaction levels for parents of children seen by study providers and assess how satisfaction changes as a function of exposure to the DART program, and 4) to assess the cost of implementing the DART program and its impact on health care expenditures.

To accomplish these aims, we propose a quasi-experimental study utilizing a stepped wedge design. In collaboration with two practice-based research networks: the electronic Pediatric Research in Office Settings (ePROS) network and the NorthShore Pediatric network, we will recruit 20 practices to participate. Over a 20 month period, the intervention will be sequentially deployed to 4 groups of practices (5 practices/group). Each practice will function as part of the control group until they receive the intervention. The DART program's effectiveness will be assessed by examining provider antibiotic prescribing rates for ARTIs (both overall and first-line), communication practices, and parent satisfaction both pre- and post-intervention exposure using survey and electronic health record data. If the DART program is effective for both reducing ARTI antibiotic prescribing to levels consistent with bacterial prevalence rates and increasing use of first-line antibiotics for bacterial ARTIs, we will have an innovative, highly disseminable QI intervention program to further address this critical public health problem.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
6 Months 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Visits to enrolled providers by children aged 6 months to 10 years with an International Classification of Diseases-10 (ICD-10) diagnosis code for AOM, bronchitis, pharyngitis, sinusitis, or upper respiratory infection (URI) will be included in the study. Only systemic (oral) antibiotic prescriptions on the same date as the study visit will be included in prescribing measures for each ARTI.

排除标准

  • ARTI visits will be excluded from measures of prescribing if there are any competing non-ARTI bacterial diagnoses (e.g. urinary tract infection) or any antibiotic prescriptions during the 30-days prior to the index visit. Visits by children with allergies to penicillin or cephalosporin antibiotics will be excluded from measures of second-line prescribing.

研究组 & 干预措施

Providers

Other

Physicians, pediatric nurse practitioners and physician assistants (referred to as providers from here forward) will be recruited from 20 practices, with a maximum of four providers participating from a single practice, for a maximum of 80 providers.

Providers will receive an online tutorials, interactive group webinars, simulated booster sessions as well as feedback reports.

干预措施: Online Tutorial (Other)

Providers

Other

Physicians, pediatric nurse practitioners and physician assistants (referred to as providers from here forward) will be recruited from 20 practices, with a maximum of four providers participating from a single practice, for a maximum of 80 providers.

Providers will receive an online tutorials, interactive group webinars, simulated booster sessions as well as feedback reports.

干预措施: Webinars (Other)

Providers

Other

Physicians, pediatric nurse practitioners and physician assistants (referred to as providers from here forward) will be recruited from 20 practices, with a maximum of four providers participating from a single practice, for a maximum of 80 providers.

Providers will receive an online tutorials, interactive group webinars, simulated booster sessions as well as feedback reports.

干预措施: Booster Sessions (Other)

Providers

Other

Physicians, pediatric nurse practitioners and physician assistants (referred to as providers from here forward) will be recruited from 20 practices, with a maximum of four providers participating from a single practice, for a maximum of 80 providers.

Providers will receive an online tutorials, interactive group webinars, simulated booster sessions as well as feedback reports.

干预措施: Feedback Reports (Other)

Parents

Other

The number of parents who participate will depend on the number of providers who agree to participate at each of the 20 practices. The total could range from a minimum of 1800 parents to a maximum of 7200 parents.

Throughout the study, parents at participating practice sites will be offered the opportunity to complete a DART Parent Survey after their child's visit.

干预措施: Parent Survey (Other)

结局指标

主要结局

Change in rates of overall antibiotic prescribing for all ARTI visits

时间窗: Two years pre-intervention and, on average, a 15-month period during and post intervention

This outcome will determine whether rates of prescribing antibiotics during pediatric ARTI visits change as a function of the intervention. A baseline period will be compared to periods both during the intervention and post-intervention. For each time-period, the investigators will assess the number of ARTI visits (denominator) where antibiotics were prescribed (numerator).

次要结局

  • Change in rates of antibiotic prescribing for pharyngitis(Two years pre-intervention and, on average, a 15-month period during and post intervention)
  • Change in rates of antibiotic prescribing for viral ARTI(Two years pre-intervention and, on average, a 15-month period during and post intervention)
  • Change in second-line prescribing rates for bacterial ARTIs(Two years pre-intervention and, on average, a 15-month period during and post intervention)
  • Use of Combined Negative and Positive Treatment Recommendations(On average 6 months pre-intervention and, on average, 9 months during intervention exposure)
  • Use of Contingency plans(On average 6 months pre-intervention and, on average, 9 months during intervention exposure)
  • Cost of intervention implementation(Two years pre-intervention and, on average, a 15-month period during and post intervention)
  • Parent-Reported Satisfaction Scores(On average 6 months pre-intervention and, on average, 9 months during intervention exposure)
  • Change in health provider expenditures due to intervention(Two years pre-intervention and, on average, a 15-month period during and post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rita Mangione-Smith

Primary Investigator

Seattle Children's Hospital

研究点 (40)

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