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

NCT ID: NCT03793946

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Anti-Infective Agents Mobile Applications Quality Improvement Antimicrobial Stewardship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

International, multicenter stepped-wedge cluster randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Masking of care providers and investigators is not feasible. Outcome assessors and data analysts will be blinded to the study arm allocation.

Study Groups

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AB-assistant

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

Group Type EXPERIMENTAL

AB-assistant

Intervention Type OTHER

The AB-assistant is an antimicrobial stewardship smartphone application that offers local antimicrobial guidelines to physicians currently assessed per website or paper/digital booklet.

Standard antimicrobial stewardship

Physicians on these wards will use conventional ways to assess local guidelines to prescribe antimicrobials.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role collaborator

University of Calgary Cumming School of Medicine

UNKNOWN

Sponsor Role collaborator

Annelies Verbon

OTHER

Sponsor Role lead

Responsible Party

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Annelies Verbon

Prof. dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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B D Huttner, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

T Tängdén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

John Conly, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Calgary Cumming School of Medicine

Locations

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University of Calgary Cumming School of Medicine and Alberta Health Services, Department of Medicine

Calgary, Alberta, Canada

Site Status

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status

Uppsala University, Dept of Medical Sciences

Uppsala, , Sweden

Site Status

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland

Site Status

Countries

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Canada Netherlands Sweden Switzerland

Central Contacts

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R I Helou, MD

Role: CONTACT

+31107033510

A Verbon, Prof. Dr.

Role: CONTACT

+31107033510

Facility Contacts

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John Conly, Prof. Dr.

Role: primary

A Verbon, Prof. Dr.

Role: primary

T Tängdén, MD, PhD

Role: primary

B D Huttner, MD, MS

Role: primary

References

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Helou RI, Catho G, Faxen L, Hulscher M, Teerenstra S, Conly J, Huttner BD, Tangden T, Verbon A. Impact of a smartphone application for appropriate antibiotic prescribing at three tertiary hospitals: an international, multicentre stepped-wedge cluster randomized trial. Clin Microbiol Infect. 2025 Jul;31(7):1172-1179. doi: 10.1016/j.cmi.2025.02.026. Epub 2025 Mar 1.

Reference Type DERIVED
PMID: 40032084 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32503867 (View on PubMed)

Other Identifiers

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ZonMw_549003001

Identifier Type: -

Identifier Source: org_study_id

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