Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application

Abstract

Introduction: With the widespread use of electronic health records and handheld electronic devices in hospitals, informatics-based antimicrobial stewardship interventions hold great promise as tools to promote appropriate antimicrobial drug prescribing. However, more research is needed to evaluate their optimal design and impact on quantity and quality of antimicrobial prescribing.

Methods and analysis: Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland. Secondary outcomes will include antimicrobial use metrics, clinical and process outcomes. A multicentre stepped-wedge cluster randomised trial will randomise entities defined as wards or specialty regarding time of introduction of the intervention. We will include 36 hospital entities with seven measurement periods in which the primary outcome will be measured in 15 participating patients per time period per cluster. At participating wards, patients of at least 18 years of age using antimicrobials will be included. After a baseline period of 2-week measurements, six periods of 4 weeks will follow in which the intervention is introduced in 6 wards (in three hospitals) until all 36 wards have implemented the intervention. Thereafter, we allow use of the app by everyone, and evaluate the sustainability of the app use 6 months later.

Ethics and dissemination: This protocol has been approved by the institutional review board of each participating centre. Results will be disseminated via media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.

Trial registration number: ClinicalTrials.gov registry (NCT03793946). Stage; pre-results.

Keywords: infectious diseases; information technology; microbiology; protocols & guidelines; therapeutics.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

Study design. In all time periods (total of 7) there is an uptake period of 2 days and a measure period of 26 days. During the baseline period only a measure period of 2 weeks will be performed.

Figure 2

Scheme of potential contamination. The potential contamination in a hospital, in and between wards, physicians and patients

Figure 3

Interface of the AB-assistant app. On the left the Home screen is shown. In the middle checkboxes are shown to guide the user to the correct therapy for Meningitis. The right screen shows details about Amoxicillin-Clavulanate regarding dosing and general spectrum of activity.