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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03793946
Acronym
AB-assistant
Enrollment
1080
Registered
2019-01-04
Start date
2020-09-30
Completion date
2022-01-31
Last updated
2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Infective Agents, Antimicrobial Stewardship, Mobile Applications, Quality Improvement

Keywords

Drug Resistance, Microbial, Multicenter Study, Decision Support Systems, Clinical

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.

Interventions

OTHERAB-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.

Sponsors

Erasmus Medical Center
CollaboratorOTHER
University Hospital, Geneva
CollaboratorOTHER
Uppsala University Hospital
CollaboratorOTHER
University of Calgary Cumming School of Medicine
CollaboratorUNKNOWN
Annelies Verbon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

International, multicenter stepped-wedge cluster randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Appropriate empirical antimicrobial therapy12 monthsAccording to predefined criteria

Secondary

MeasureTime frameDescription
Total prescription of antimicrobial drugs per AWaRe category in DDD/admission12 monthsPer AWaRe category in DDD/admission
Antimicrobial costs12 monthsTotal costs of antimicrobial drugs administered
Length of hospital stay (LOS)12 months(LOS)
In-hospital mortality12 monthsAll cause in-hospital mortality
Hospital readmission within 30 days of discharge12 monthsUnplanned hospital readmissions within 30 days after discharge
Total prescription of antimicrobial drugs12 monthsIn defined daily dose (DDD)/admission
Incidence Clostridium difficile infections (CDI)12 monthsIncidence of healthcare facility onset Clostridium difficile
Incident clinical cultures with multi-drug resistant organisms (MDRO)12 monthsIncidence 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-assistant12 monthsTotal 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 it12 monthsQuestionnaire
Number of infectious diseases consultations12 monthsTotal amount of infectious diseases consultations
Transfer to intermediate care or ICU12 months% of admissions transferred to intermediate care or ICU after initial non-intermediate care or non-ICU admission

Countries

Canada, Netherlands, Sweden, Switzerland

Contacts

Primary ContactR I Helou, MD
r.helou@erasmusmc.nl+31107033510
Backup ContactA Verbon, Prof. Dr.
a.verbon@erasmusmc.nl+31107033510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026