E-PAUse: Encouraging Proper Antibiotic Use in Outpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Total number of antibiotics courses prescribed for URTIs
研究概览
简要总结
Specific Aim 1: To determine the knowledge, attitude, and practice (KAP) of PHCC physicians regarding appropriate prescription of antibiotics in the outpatient setting.
Hypothesis 1a: PHCC physicians will have adequate theoretical knowledge regarding use of antibiotics for upper respiratory tract infections.
Hypothesis 1b: Despite adequate theoretical knowledge, fear of complications of untreated infection and patient demand and expectations will drive inappropriate antibiotic prescription for upper respiratory tract infections
Specific Aim 2: To test the effectiveness of a comprehensive multi-component intervention in a cluster randomized trial upon rate of antibiotics prescription for upper respiratory tract infections in individuals aged > 2 years presenting to primary care by PHCC physicians Hypothesis 2: Compared with a single intervention, a comprehensive multi-component intervention package will be associated with a significant reduction in inappropriate antibiotic prescription.
Investigators will conduct this study in the Primary Healthcare Center (PHCC) setting in Qatar. Investigators will identify four large PHCCs from the existing active centers. The study has 2 parts. Part 1 corresponds to specific aim 1 and comprises of a KAP survey which will be carried out in all four PHCCs and will include all physicians. Part 2 corresponds to specific aim 2 and is a cluster randomized clinical trial in which Investigators will randomize the four PHCCs into two groups.
First group (2 PHCCs) will receive training in appropriate documentation of infections and antibiotics prescription and will continue to provide usual care. Second group (2 PHCCs) will receive the comprehensive multi-component intervention, which consists of four elements:
- Option for deferred prescription fulfilment;
- Education of staff regarding appropriate uses of antibiotics,
- algorithm-driven decision support tool,
- Feedback on individual and group performance.
详细描述
As above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >2 years old presenting to any of the selected PHCCs (rationale: signs and symptoms of bacterial infection in very young children are more non-specific and empiric antibiotics are often indicated due to serious consequences of unrecognized and untreated bacterial infections)
- •Presenting with acute (<1 week of symptoms) upper respiratory tract infection (URTI) like illness including
- •common cold/acute rhinitis/nasopharyngitis
- •laryngitis/laryngotracheitis
- •Acute bronchitis
- •acute otitis media
- •influenza (confirmed or influenza-like illness)
- •pharyngitis/tonsillitis
- •acute sinusitis
排除标准
- •Known immune compromised status, e.g., cystic fibrosis, cancer, organ transplant recipient.
- •On immune suppressive therapy for any duration (e.g., steroids, disease modifying antirheumatic agents; cancer chemotherapy, anti-rejection drugs, etc.) in one year prior to presentation
- •Known or diagnosed bacterial cause of infection.
- •Severe systemic illness requiring referral to the emergency department or hospitalization within 24 hours of presentation
- •Known or suspected chronic obstructive pulmonary disease. Asplenic patients (anatomic or functional)
结局指标
主要结局
Total number of antibiotics courses prescribed for URTIs
时间窗: Primary Analysis 11 months; Final analysis 24 months
For each recorded diagnosis of URTI, investigators will count the number of persons who received an antibiotic prescription. All prescriptions regardless of drug, dose, route of administration and duration will be counted. Only one prescription per 30-day period will be counted to exclude those with ongoing, evolving, or unresolved infection.
Proportion of antibiotics prescription dispensed for an inappropriate use
时间窗: Total 11 months for primary analysis; Follow-up up to 36 months
For each antibiotic prescription written for a URTI diagnosis, investigators will determine the appropriateness of antibiotics based on our previously published criteria.
次要结局
- Rates of hospitalization in 28 days after the PHCC visit(Total 11 months for primary analysis; Follow-up up to 36 months)
- Rates of ED visits in 28 days after the PHCC visit(Total 11 months for primary analysis;)
研究者
Adeel Ajwad Butt
Senior Consultant in Infectious Disease
Hamad Medical Corporation