A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant (AB-assistant)
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|ClinicalTrials.gov Identifier: NCT03793946|
Recruitment Status : Not yet recruiting
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anti-Infective Agents Mobile Applications Quality Improvement Antimicrobial Stewardship||Other: AB-assistant||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||1080 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||International, multicenter stepped-wedge cluster randomized trial|
|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.|
|Official Title:||A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant: an International, Multicenter Stepped-wedge Cluster Randomized Trial|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||October 2020|
Use of the AB-assistant app by physicians in intervention wards.
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.
- Appropriate empirical antimicrobial therapy [ Time Frame: 12 months ]According to predefined criteria
- Total prescription of antimicrobial drugs [ Time Frame: 12 months ]In defined daily dose (DDD)/admission
- Total prescription of antimicrobial drugs per AWaRe category in DDD/admission [ Time Frame: 12 months ]Per AWaRe category in DDD/admission
- Antimicrobial costs [ Time Frame: 12 months ]Total costs of antimicrobial drugs administered
- Length of hospital stay (LOS) [ Time Frame: 12 months ](LOS)
- In-hospital mortality [ Time Frame: 12 months ]All cause in-hospital mortality
- Hospital readmission within 30 days of discharge [ Time Frame: 12 months ]Unplanned hospital readmissions within 30 days after discharge
- Transfer to intermediate care or ICU [ Time Frame: 12 months ]% of admissions transferred to intermediate care or ICU after initial non-intermediate care or non-ICU admission
- Incidence Clostridium difficile infections (CDI) [ Time Frame: 12 months ]Incidence of healthcare facility onset Clostridium difficile
- Incident clinical cultures with multi-drug resistant organisms (MDRO) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]Questionnaire
- Number of infectious diseases consultations [ Time Frame: 12 months ]Total amount of infectious diseases consultations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793946
|Contact: R I Helou, MDemail@example.com|
|Contact: A Verbon, Prof. Dr.||+firstname.lastname@example.org|
|University of Calgary Cumming School of Medicine and Alberta Health Services, Department of Medicine||Not yet recruiting|
|Calgary, Alberta, Canada, T2N 2TN|
|Contact: John Conly, Prof. Dr. email@example.com|
|Erasmus Medical Center||Not yet recruiting|
|Rotterdam, Zuid Holland, Netherlands, 3015 CN|
|Contact: A Verbon, Prof. Dr. firstname.lastname@example.org|
|Uppsala University, Dept of Medical Sciences||Not yet recruiting|
|Uppsala, Sweden, 751 85|
|Contact: T Tängdén, MD, PhD email@example.com|
|Geneva University Hospitals||Not yet recruiting|
|Geneva, GE, Switzerland, 1211|
|Contact: B D Huttner, MD, MS firstname.lastname@example.org|
|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|