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

A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant: an International, Multicenter Stepped-wedge Cluster Randomized Trial

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).

Study Overview

• Status: Unknown
• Conditions: Mobile Applications; Quality Improvement; Anti-Infective Agents; Antimicrobial Stewardship
• Intervention / Treatment: Other: AB-assistant

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 Type: Interventional
• Enrollment (Anticipated): 1080
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: R I Helou, MD; Phone Number: +31107033510; Email: r.helou@erasmusmc.nl
• Study Contact Backup: Name: A Verbon, Prof. Dr.; Phone Number: +31107033510; Email: a.verbon@erasmusmc.nl

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2TN
      • University of Calgary Cumming School of Medicine and Alberta Health Services, Department of Medicine
      • Contact: John Conly, Prof. Dr.; Email: john.conly@albertahealthservices.ca
• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015 CN
      • Erasmus Medical Center
      • Contact: A Verbon, Prof. Dr.; Email: a.verbon@erasmusmc.nl
• Sweden
  • Uppsala, Sweden, 751 85
    • Uppsala University, Dept of Medical Sciences
    • Contact: T Tängdén, MD, PhD; Email: thomas.tangden@medsci.uu.se
• Switzerland
  • GE
    • Geneva, GE, Switzerland, 1211
      • Geneva University Hospitals
      • Contact: B D Huttner, MD, MS; Email: benedikt.huttner@hcuge.ch
      • Sub-Investigator: G Catho, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AB-assistant; Use of the AB-assistant app by physicians in intervention wards.	Other: AB-assistant; The AB-assistant is an antimicrobial stewardship smartphone application that offers local antimicrobial guidelines to physicians currently assessed per website or paper/digital booklet.
No Intervention: Standard antimicrobial stewardship; Physicians on these wards will use conventional ways to assess local guidelines to prescribe antimicrobials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate empirical antimicrobial therapy	According to predefined criteria	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total prescription of antimicrobial drugs	In defined daily dose (DDD)/admission	12 months
Total prescription of antimicrobial drugs per AWaRe category in DDD/admission	Per AWaRe category in DDD/admission	12 months
Antimicrobial costs	Total costs of antimicrobial drugs administered	12 months
Length of hospital stay (LOS)	(LOS)	12 months
In-hospital mortality	All cause in-hospital mortality	12 months
Hospital readmission within 30 days of discharge	Unplanned hospital readmissions within 30 days after discharge	12 months
Transfer to intermediate care or ICU	% of admissions transferred to intermediate care or ICU after initial non-intermediate care or non-ICU admission	12 months
Incidence Clostridium difficile infections (CDI)	Incidence of healthcare facility onset Clostridium difficile	12 months
Incident clinical cultures with multi-drug resistant organisms (MDRO)	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	12 months
Uptake of the AB-assistant	Total users and number of sessions per user, time spent per session, time spent per screen, number of times each screen is viewed.	12 months
Actual use of AB-assistant and experiences while using it	Questionnaire	12 months
Number of infectious diseases consultations	Total amount of infectious diseases consultations	12 months

Collaborators and Investigators

• Sponsor: Annelies Verbon
• Collaborators: University Hospital, Geneva; Erasmus Medical Center; Uppsala University Hospital; University of Calgary Cumming School of Medicine
• Investigators: Principal Investigator: B D Huttner, MD, MS, University Hospital, Geneva; Principal Investigator: T Tängdén, MD, PhD, Uppsala University; Principal Investigator: John Conly, Prof. Dr., University of Calgary Cumming School of Medicine

Publications and helpful links

General Publications

• Helou RI, Catho G, Peyravi Latif A, Mouton J, Hulscher M, Teerenstra S, Conly J, Huttner BD, Tangden T, Verbon A. Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application. BMJ Open. 2020 Jun 4;10(6):e033640. doi: 10.1136/bmjopen-2019-033640.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Multicenter Study; Decision Support Systems, Clinical; Drug Resistance, Microbial
• Other Study ID Numbers: ZonMw_549003001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified raw data will be made publicly on request available from the time of publication or within a reasonable time period of the experiments being completed. General project data and metadata will be included in the supplementary data of published articles if needed and or shared through university repositories.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No