A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant

Not Applicable

• Conditions: Anti-Infective Agents; Mobile Applications; Quality Improvement; Antimicrobial Stewardship
• Interventions: Other: AB-assistant

• Registration Number: NCT03793946
• Lead Sponsor: Annelies Verbon

Brief Summary

Optimal prescribing of antimicrobials is becoming increasingly challenging because of the growing complexity of guidelines and constantly changing distribution of infectious pathogens. Prescribing antimicrobials appropriately according to local guidelines optimizes therapy for the individual patient and reduces the emergence of resistance. By adapting and evaluating a smartphone based app containing local guidelines we aim to study appropriate prescribing of antimicrobials by physicians in three hospitals (Netherlands, Sweden and Switzerland).

Detailed Description

Rationale: Antimicrobials are an indispensable part of modern medicine. However, optimal prescription of these agents is becoming increasingly challenging because of the growing complexity of guidelines, and constantly changing epidemiology of infectious pathogens. Moreover, due to local variations in the prevalence of certain pathogens and antimicrobial resistance (AMR), antimicrobial choices need to be tailored to local epidemiology. Improvement of antimicrobial use, in particular prevention of overuse and suboptimal use of antimicrobials, through antimicrobial stewardship (AMS) programs is increasingly regarded as indispensable, both to optimize therapy for the individual patients as well as to reduce emergence and spread of AMR. With the widespread use of electronic health records (EHR) and handheld electronic devices in hospitals, informatics-based AMS interventions hold great promise as tools to improve antimicrobial prescribing. However, they are still underdeveloped, understudied and underutilized.

Objective: The study aims to adapt and evaluate the "AB-assistant", a smartphone based digital stewardship application that is customizable to local guidelines by local antibiotic stewards and therefore has the potential to be used worldwide, including in low- and middle-income countries.

Study design: The existing North American Spectrum app (SpectrumMD; Canada) will be adjusted and translated for the European market. During a usability study physicians will use the app for two weeks followed by individual interviews to determine facilitators and barriers of app use. Based on the results of these interviews the app will be adjusted if necessary. After adaptation and usability testing, thereafter the AB-assistant app will be evaluated in an international, multicentre, randomized clinical trial involving centres in 3 countries in different settings with appropriate antimicrobial use as a primary outcome. In a stepped wedge cluster randomized trial, wards will be randomised after stratification for specialty. At baseline a 2-week measurement period will be done, followed by the introduction of the intervention to 6 wards (in 3 hospitals) with a 4-week interval with 6 inclusion periods. This cycle will be repeated with the inclusion of all new intervention wards. We include the 36 wards in total during the 6 inclusion phases and at the end of the inclusion time we allow use of the app by everyone, also wards not included in the study.

Study Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04
• Study Start: 2020-09
• Primary Completion: 2021-09
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1080

Inclusion Criteria

Cluster level (wards):

• Medical and surgical wards.

Physician level:

• All physicians involved in antibiotic prescribing decisions in the participating wards.

Patient level:

• All patients hospitalized in the participating wards >= 18 years of age to whom systemic antimicrobials are prescribed.

Exclusion Criteria

Cluster level (wards):

• Outpatient clinics
• Psychiatry wards
• ICU

Physician level:

• None

Patient level:

• None

Treatment level:

• Surgical and medical prophylaxis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AB-assistant	AB-assistant	Use of the AB-assistant app by physicians in intervention wards.

Primary Outcome Measures

Name	Time	Method
Appropriate empirical antimicrobial therapy	12 months	According to predefined criteria

Secondary Outcome Measures

Name	Time	Method
Total prescription of antimicrobial drugs	12 months	In defined daily dose (DDD)/admission
Total prescription of antimicrobial drugs per AWaRe category in DDD/admission	12 months	Per AWaRe category in DDD/admission
Antimicrobial costs	12 months	Total costs of antimicrobial drugs administered
Length of hospital stay (LOS)	12 months	(LOS)
In-hospital mortality	12 months	All cause in-hospital mortality
Hospital readmission within 30 days of discharge	12 months	Unplanned hospital readmissions within 30 days after discharge
Transfer to intermediate care or ICU	12 months	% of admissions transferred to intermediate care or ICU after initial non-intermediate care or non-ICU admission
Incidence Clostridium difficile infections (CDI)	12 months	Incidence of healthcare facility onset Clostridium difficile
Incident clinical cultures with multi-drug resistant organisms (MDRO)	12 months	Incidence of clinical cultures with multidrug resistant organisms (methicillin-resistant Staphylococcus aureus (MRSA), Extended spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E), carbapenemase-producing Enterobacteriaceae (CPE), vancomycin-resistant enterococci (VRE), multidrug resistant P. aeruginosa) denominated per 1000 patient days and admissions
Uptake of the AB-assistant	12 months	Total users and number of sessions per user, time spent per session, time spent per screen, number of times each screen is viewed.
Actual use of AB-assistant and experiences while using it	12 months	Questionnaire
Number of infectious diseases consultations	12 months	Total amount of infectious diseases consultations

Trial Locations

Locations (4)

University of Calgary Cumming School of Medicine and Alberta Health Services, Department of Medicine; 🇨🇦 Calgary, Alberta, Canada

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

Uppsala University, Dept of Medical Sciences; 🇸🇪 Uppsala, Sweden

Geneva University Hospitals; 🇨🇭 Geneva, GE, Switzerland