Broad Implementation of Outpatient Stewardship (BIOS) Project
概览
- 阶段
- 不适用
- 干预措施
- Broad Implementation of Outpatient Stewardship (BIOS) intervention
- 疾病 / 适应症
- Acute Respiratory Tract Infection
- 发起方
- Children's Hospital of Philadelphia
- 入组人数
- 1032
- 试验地点
- 5
- 主要终点
- Rate of broad-spectrum (off-guideline) antibiotic prescribing for all bacterial ARTIs
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
Reducing inappropriate antibiotic use is a key strategy to mitigate antibiotic resistance and adverse health effects associated with antibiotic exposure. The Broad Implementation of Outpatient Stewardship (BIOS) project focuses on broadly implementing an evidence-based intervention to improve antibiotic prescribing for acute respiratory tract infections in pediatric outpatient settings. Primary aims include: (1) examining the acceptability, feasibility and utility of a focused implementation strategy on improving intervention adoption and impact and (2) measuring the effectiveness of the intervention to reduce unnecessary broad-spectrum antibiotic prescription.
详细描述
Antibiotics are commonly prescribed for acute respiratory tract infections (ARTIs) in pediatric outpatient settings, but up to half of antibiotic use is inappropriate. Prior work demonstrated broad-spectrum antibiotics did not improve patient health outcomes compared to narrow-spectrum antibiotics, but did increase harmful side effects. Overuse of broad-spectrum antibiotics can exacerbate antibiotic resistance and drug-related adverse events. Certain interventions have been effective in improving antibiotic prescribing, but none have been implemented widely. The BIOS project focuses on broadly implementing an evidence-based intervention to improve how clinicians in outpatient settings prescribe antibiotics for ARTIs in children 6 months to 12 years old. The intervention consists of educational modules and prescribing audit and feedback reports delivered to clinicians in a variety of outpatient settings across 5 health systems. Primary aims include: (1) examining the acceptability, feasibility and utility of a focused implementation strategy on improving intervention adoption and impact and (2) measuring the effectiveness of the intervention to reduce unnecessary broad-spectrum antibiotic prescription. Clinicians will be randomized to one of two arms: an early intervention arm or a delayed intervention (control) arm. The study will use a 4-period design, where the periods are as follows: Period 0: Baseline period that occurs prior to randomization Period 1: clinicians in the early intervention arm receive the intervention Period 2: All clinicians (both arms) receive the intervention Period 3: Maintenance period, external support from the study team is removed
研究者
入排标准
入选标准
- •Clinician inclusion criteria: Any non-trainee clinician who prescribes and provides care for children aged 6 months to 12 years with ARTIs and who is practicing at an included site. Clinicians will further be selected based on employment status at time of randomization and volume of prescribing over the past 12 months.
- •Visit inclusion criteria: visits made by patients of all participating practices aged 6 months through 12 years of age will be considered part of the project population.
排除标准
- •Clinician exclusion criteria: clinicians who are trainees, who do not prescribe (or prescribe very infrequently) to the patient population of interest, or who do not provide care for (or provide care very infrequently for) children aged 6 months to 12 years with ARTIs will be excluded
- •Visit exclusion criteria: visit by children with complex chronic conditions, as well as those treated with an antibiotic in the past 30 days, will have their data extracted but will be excluded from analyses
研究组 & 干预措施
Early Intervention
The early intervention arm will begin receiving the intervention in study period 1.
干预措施: Broad Implementation of Outpatient Stewardship (BIOS) intervention
Delayed Intervention (Control)
The delayed intervention (control) arm will begin receiving the intervention in study period 2. They will receive no intervention during period 1.
干预措施: Broad Implementation of Outpatient Stewardship (BIOS) intervention
结局指标
主要结局
Rate of broad-spectrum (off-guideline) antibiotic prescribing for all bacterial ARTIs
时间窗: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed. Assessed using electronic health record data.
Rate of antibiotic prescribing for all ARTIs (viral and bacterial)
时间窗: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed
Engagement with intervention
时间窗: Period 1 through period 3 (up to 40 months of intervention time following intervention initiation)
Investigators will measure clinicians' completion rates of the educational modules and view rates of the feedback reports. Assessed through clinician attestation.
Implementation of the intervention
时间窗: Surveys administered at the start of or just prior to period 1, during period 2, and during period 3. Interviews conducted during period 2 and period 3.
Investigators will use surveys and qualitative interviews to measure the extent to which the intervention was implemented as designed.
次要结局
- Rate of broad-spectrum (off-guideline) antibiotic prescribing by practice setting(from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation))
- Rate of broad-spectrum (off-guideline) antibiotic prescribing by ARTI type(from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation))
- Rate of broad-spectrum (off-guideline) antibiotic prescribing by intervention participation status(from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation))
- Rate of broad-spectrum (off-guideline) antibiotic prescribing by geographic location within each practice setting(from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation))
- Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by practice setting(from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation))
- Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by intervention participation status(from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation))
- Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by geographic location within each practice setting(from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation))