跳至主要内容
临床试验/NCT05451836
NCT05451836已完成不适用

Patient, Physician, and Organizational Factors Influencing Decision-making for Antibiotic Use, and N-of-1 Trials of Interventions to Improve the Decision-making

Tan Tock Seng Hospital5 个研究点 分布在 1 个国家目标入组 15,157 人开始时间: 2022年7月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15,157
试验地点
5
主要终点
Antibiotic prescribing rates

研究概览

简要总结

Antibiotics have brought about a substantial reduction in infectious mortality. However, inappropriate antibiotic use has driven the rapid increase in antibiotic resistance. The Centers for Disease Control and Prevention estimates that at least 2 million people in the United States (US) become infected with antibiotic-resistant bacteria each year, and at least 23,000 people die each year as a direct result of these infections.

Antimicrobial stewardship programs have largely focused on inpatient settings and have excluded emergency departments (ED). The ED is a unique healthcare setting which is distinct from inpatient and other ambulatory settings. Given the many factors that could influence inappropriate antibiotic prescribing, a one-size-fits-all approach is unlikely to work for all physicians and all regions. Hence, the design and implementation of tailored interventions based on the understanding of the local patient, physician, and ED organizational factors are pertinent for the interventions. The team has conducted a mixed-methods study to understand the patient, physician, and organisational factors that influence antibiotic prescribing in the local EDs. The findings of the study were used to design two interventions which will be implemented in four EDs in Singapore to reduce the inappropriate antibiotic prescribing in the ED.

This study aims to evaluate the effectiveness of 2 tailored antimicrobial stewardship interventions in reducing antibiotic prescribing rates for uncomplicated URTI patients attending four adult EDs in Singapore:

  1. Patient education via information leaflets addressing knowledge-, perception-, and belief-gaps of the local patient population on antibiotic use for URTI
  2. Two-monthly physician feedback on their antibiotic prescribing rates by senior ED doctors coupled with bite-sized information on good antibiotic prescribing practices.

The study will include an initial control period of 18 months where none of the 4 hospitals will be exposed to the interventions. At the beginning of the intervention period, the 4 hospitals will be randomly assigned to one of the 2 interventions (Patient education or physician feedback). At the end of 6 months, all hospitals will receive the other intervention and be exposed to both interventions concurrently. Data will be collected for another 6 months to assess if the effects of the interventions are persistent.

详细描述

Antibiotics, along with improved sanitation and vaccination, have brought about a substantial reduction in infectious mortality. However, inappropriate antibiotic use has driven the rapid increase in antibiotic resistance. The Centers for Disease Control and Prevention estimates that at least 2 million people in the United States (US) become infected with antibiotic-resistant bacteria each year, and at least 23,000 people die each year as a direct result of these infections.

To date, antimicrobial stewardship programs attempting to optimize antibiotic therapy and clinical outcomes have largely focused on inpatient settings and have excluded emergency departments (ED). The ED is a unique healthcare setting which is distinct from inpatient and other ambulatory settings. Given the multi-factorial nature of inappropriate antibiotic prescribing, it is unlikely that a single approach will work for all physicians in all regions. Hence, the design and implementation of tailored interventions based on the understanding of the local patient, physician, and ED organizational factors are pertinent for the interventions. The team has conducted a mixed-methods study to understand the patient, physician, and organisational factors that influence antibiotic prescribing in the local EDs. The findings of the study were used to design two interventions which will be implemented in four EDs in Singapore to reduce the inappropriate antibiotic prescribing in the ED.

This study aims to evaluate the effectiveness of 2 tailored antimicrobial stewardship interventions in reducing antibiotic prescribing rates for uncomplicated URTI patients attending four adult EDs in Singapore:

  1. Patient education via information leaflets addressing knowledge-, perception-, and belief-gaps of the local patient population on antibiotic use for URTI
  2. Two-monthly physician feedback on their antibiotic prescribing rates by senior ED doctors coupled with bite-sized information on good antibiotic prescribing practices.

Using the stepped wedge design, the study will include an initial control period of 18 months where none of the 4 hospitals will be exposed to the interventions. During the intervention period, the 4 hospitals will be randomly assigned to one of the 2 tailored interventions. At the end of 6 months, all hospitals will receive the other intervention and be exposed to both interventions concurrently. Data will be collected for another 6 months to assess the persistence of the effects of the interventions.

研究设计

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

入排标准

年龄范围
21 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 21 years and above
  • Attendance at any of the study sites' Emergency Department: National University Hospital, Khoo Teck Puat Hospital, Changi General Hospital and Tan Tock Seng Hospital
  • Presenting with upper respiratory tract infections
  • Physicians:
  • Working at any of the study sites' Emergency Department: National University Hospital (NUH), Khoo Teck Puat Hospital (KTPH), Changi General Hospital (CGH), Tan Tock Seng Hospital (TTSH) and Sengkang General Hospital (SKH), during the study period

排除标准

  • 未提供

研究组 & 干预措施

Group 1

Experimental

Group 1 (Two emergency departments) will receive patient education leaflets for 6 months and will receive physician feedback for the next 6 months on top of the patient education.

干预措施: Patient education leaflets (Other)

Group 1

Experimental

Group 1 (Two emergency departments) will receive patient education leaflets for 6 months and will receive physician feedback for the next 6 months on top of the patient education.

干预措施: Physician feedback (Other)

Group 2

Experimental

Group 1 (Two emergency departments) will receive physician feedback for 6 months and will receive patient education leaflets for the next 6 months on top of the physician feedback.

干预措施: Patient education leaflets (Other)

Group 2

Experimental

Group 1 (Two emergency departments) will receive physician feedback for 6 months and will receive patient education leaflets for the next 6 months on top of the physician feedback.

干预措施: Physician feedback (Other)

结局指标

主要结局

Antibiotic prescribing rates

时间窗: Measured monthly for 15 months

The antibiotic prescribing rates are computed by dividing the number of URTI patients prescribed with antibiotics with the total number of URTI seen by the physician. The data is obtained from the electronic medical records.

次要结局

未报告次要终点

研究者

发起方
Tan Tock Seng Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chow Li Ping Angela

Head and Senior Consultant

Tan Tock Seng Hospital

研究点 (5)

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