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

Study Overview
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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.

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

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

Intervention / Treatment
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* Other: AB-assistant


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: International, multicenter stepped-wedge cluster randomized trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Resistance, Microbial, Multicenter Study, Decision Support Systems, Clinical