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临床试验/NCT03674775
NCT03674775尚未招募不适用

Dialogue Around Respiratory Illness Treatment for Family Practice (DART -FP)

Seattle Children's Hospital0 个研究点目标入组 180 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
180
主要终点
Overall antibiotic prescribing rates for pediatric and adult ARTIs.

研究概览

简要总结

Antibiotic prescribing for childhood acute respiratory tract infections (ARTIs), including acute otitis media (AOM), pharyngitis, sinusitis, bronchitis, and upper respiratory infection (URI), is common in the United States (US). In the outpatient setting, more than 50% of children diagnosed with ARTIs receive antibiotic prescriptions. Considering that the estimated US prevalence of pediatric bacterial ARTIs is 27% (with the remainder of ARTIs caused by viruses) this represents a substantial degree of antibiotic overuse nationwide. Another troubling trend in antibiotic prescribing for ARTIs in children is the increased reliance on broad-spectrum, second-line agents for bacterial ARTIs. Unwarranted use of antibiotics, especially broad-spectrum agents, has been associated with increased resistance among several strains of bacteria that commonly cause ARTIs, posing risks to both individuals and communities.

详细描述

Provider-parent communication during ARTI visits often drives unwarranted antibiotic prescribing. Dr. Mangione-Smith (proposed principal investigator) and colleagues developed a quality improvement (QI) intervention for pediatric providers called the Dialogue Around Respiratory Illness Treatment (DART) program. The DART QI program is a multifaceted, web-based intervention that is delivered asynchronously over a 9-month period and takes a total of 2 hours to complete. DART's content is based on over a decade of observational research conducted by Mangione-Smith et al focused on optimizing provider-parent communication during pediatric ARTI visits in order to reduce unnecessary antibiotic prescribing while still maintaining parent satisfaction with care.[cites] The DART program also includes content related to evidence-based antibiotic prescribing with a particular focus on reducing the use of second-line, broad-spectrum antibiotics for bacterial ARTIs.

Under funding from the Eunice Kennedy National Institute for Child Health and Human Development (NICHD), the investigators recently conducted a trial of the DART QI program with 55 providers from 20 practices belonging to one of two pediatric practice-based research networks: the Pediatric Research in Office Settings (PROS) and NorthShore University Health System networks. Exposure to the DART QI program resulted in an proportional decrease from for overall antibiotic prescribing rates for ARTIs and a proportional decrease from for the use of second-line antibiotics for bacterial ARTIs comparing the baseline to the post-intervention periods.

The DART QI Program represents a new, innovative tool to address antibiotic over-use for ARTIs in the pediatric outpatient setting. However, it is unclear whether the program will be effective when disseminated to the family practice clinical setting where 23% of children receive their acute illness care nationally. It is also unclear how exposure to the communication strategies outlined in the DART QI program may influence provider-patient communication during adult encounters for ARTI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Children or adults with acute respiratory tract infections (ARTIs) defined as bacterial (acute otitis media [AOM], pharyngitis, and sinusitis) or viral (bronchitis and viral upper respiratory infection [URI]) based on their common etiologies.
  • Seven months old and older

排除标准

  • 0 - 6 months old

结局指标

主要结局

Overall antibiotic prescribing rates for pediatric and adult ARTIs.

时间窗: The primary outcomewill be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.

The primary outcome of overall antibiotic prescribing rates for ARTIs will be assessed by calculating the number of eligible ARTI visits occurring within a measurement period (measure denominator) where antibiotics were prescribed (numerator). This outcome will be assessed separately for the eligible pediatric (6 months to 17 years-old) and adult (\> 18 years-old) patients.

次要结局

  • Net cost of delivering the DART QI program(This outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.)
  • First-line antibiotic prescribing rates for pediatric and adult bacterial ARTIs.(The secondary outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.)

研究者

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

Rita Mangione-Smith

Professor and Chief

Seattle Children's Hospital

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