Evaluating the Impact of a Lao Language Mobile Phone Antimicrobial Use Guideline Application on Antimicrobial Prescribing in Laos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Proportion of antimicrobial prescriptions adherent with prescribing guidelines
研究概览
简要总结
The overall aim of this study is to compare the proportion of antimicrobial prescriptions adherent with prescribing guidelines delivered by mobile phone application (app) versus paper-based prescribing guidelines in both in- and outpatients in six hospitals in Laos.
This is an open cohort stepped-wedge cluster randomized controlled trial 3-step trial (4-month intervals at each step) with a 4-month pre-intervention period). The study conducts in six hospitals across Laos. This is 16 months-study. The intervention is a MicroGuide antimicrobial prescribing guideline mobile phone application and antimicrobial stewardship (AMS) training; whilst the reference is paper-based antimicrobial prescribing guidelines. The main outcome of interest is the proportion of antimicrobial prescriptions adherent with prescribing guidelines delivered by app-based versus paper-based prescribing guidelines at month 16 (12 months' exposure in each group). Outcome measurements are Point prevalence surveys (PPS) of hospital antimicrobial use, prescriber questionnaires and AMS knowledge survey of the prescribers. Simple random sampling will be used to select the order (step) of interventions implementation for a group of hospitals (two hospitals per group and one group per step). Neither hospitals nor investigators are blinded to the timing of intervention. Open Data Kit (ODK) system will be used as data collection instrument. All data will be kept securely, protected by password access with automatic daily backup. A logistic mixed-effects regression model will be used to compare the proportion of antimicrobial prescription adherence measured cross-sectionally at month 0, 4, 8, 12 and month 16 after introduction of prescribing guidelines delivered by mobile phone application versus paper-based. This study was approved by University of Health Sciences, Vientiane, Lao PDR and Oxford Tropical Ethics Committee (OxTREC), University of Oxford, United Kingdom.
详细描述
Background Antimicrobial prescribing applications are a promising tool to improve prescribing. However, there has been no evidence from trials to support whether the antimicrobial prescribing guidelines in the format of a mobile phone application are superior to conventional means (i.e. paper-based) in low- and middle-income countries (LMIC). This trial could have a significant impact in Laos and in other LMICs, and inform policy globally, by improving prescribing and hence reducing AMR.
Objectives Primary objective To compare the proportion of antimicrobial prescriptions adherent with prescribing guidelines delivered by mobile phone application (app-based) versus paper-based prescribing guidelines in both in- and outpatients in six general hospitals in Laos
Secondary objectives are to compare:
- change in antimicrobial defined daily doses (DDDs) after introduction of paper-based versus app-based guidelines + antimicrobial stewardship (AMS) training in both in- and out patients
- change in proportion of patients receiving intravenous antimicrobials route between paper-based and app-based guidelines + AMS training in both in- and out patients
- AMS knowledge level of the prescribers before and after app-based guidelines and AMS training
- prescriber satisfaction with/acceptability of paper-based versus app-based guidelines
- antimicrobial costs before and after app-based guidelines and AMS training
- proportion of patients admitted to hospital receiving an antimicrobial prescription before and after paper-based; and the app-based guidelines + AMS training Methods This is an open cohort stepped wedge cluster randomized controlled trial in six hospitals across Laos. The six hospitals have been purposively selected based on their capacity, location, previous participation in PPS program with available hospital antimicrobial use and antimicrobial susceptibility data. The sample size of 6 hospitals was estimated assuming 30% of antimicrobial prescription adherence with the paper-based prescribing guideline, and assuming 0.05 intra-cluster correlation coefficient. This will have 80% of power of the test to be able to detect 15% minimum difference after introduction of the mobile phone app prescribing guidelines at 0.05 significant level. This is a 3-step trial with one baseline measurement after introduction of the paper-based prescribing guidelines. Six hospitals have been divided into 3 pairs based on the geographical location and convenience for conducting the surveys.
Study intervention and reference
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Six hospitals have been purposively selected based on their capacity, location, previous participation in our PPS program with available hospital antimicrobial use and antimicrobial susceptibility data
排除标准
- •Other hospitals in Laos which are in indicated in the inclusion criteria
结局指标
主要结局
Proportion of antimicrobial prescriptions adherent with prescribing guidelines
时间窗: 16 months (12 months' exposure in each group)
Point prevalence surveys of hospital antimicrobial prescribing in both in- and outpatients (every 4 months until month 16)
次要结局
- Proportion of antimicrobials oral administration(16 months (12 months' exposure in each group))
- Prescriber satisfaction/acceptability of the prescribing guidelines(16 months (12 months' exposure in each group))
- Proportion of antimicrobial prescription pre-trial versus trial(16 months)
- Antimicrobial defined daily doses (DDDs)(16 months (12 months' exposure in each group))
- AMS knowledge level of prescribers(16 months (12 months' exposure in each group))
- Total costs of antimicrobials prescribed(16 months (12 months' exposure in each group))