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Trial record 15 of 11567 for:    Anti-Infective Agents AND antibacterial

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03793946
Recruitment Status : Not yet recruiting
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Erasmus Medical Center
University Hospital, Geneva
Uppsala University Hospital
University of Calgary Cumming School of Medicine
Information provided by (Responsible Party):
Annelies Verbon, Erasmus Medical Center

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).

Condition or disease Intervention/treatment Phase
Anti-Infective Agents Mobile Applications Quality Improvement Antimicrobial Stewardship Other: AB-assistant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.

Primary Outcome Measures :
  1. Appropriate empirical antimicrobial therapy [ Time Frame: 12 months ]
    According to predefined criteria

Secondary Outcome Measures :
  1. Total prescription of antimicrobial drugs [ Time Frame: 12 months ]
    In defined daily dose (DDD)/admission

  2. Total prescription of antimicrobial drugs per AWaRe category in DDD/admission [ Time Frame: 12 months ]
    Per AWaRe category in DDD/admission

  3. Antimicrobial costs [ Time Frame: 12 months ]
    Total costs of antimicrobial drugs administered

  4. Length of hospital stay (LOS) [ Time Frame: 12 months ]

  5. In-hospital mortality [ Time Frame: 12 months ]
    All cause in-hospital mortality

  6. Hospital readmission within 30 days of discharge [ Time Frame: 12 months ]
    Unplanned hospital readmissions within 30 days after discharge

  7. 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

  8. Incidence Clostridium difficile infections (CDI) [ Time Frame: 12 months ]
    Incidence of healthcare facility onset Clostridium difficile

  9. 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

  10. 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.

  11. Actual use of AB-assistant and experiences while using it [ Time Frame: 12 months ]

  12. Number of infectious diseases consultations [ Time Frame: 12 months ]
    Total amount of infectious diseases consultations

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03793946

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Contact: R I Helou, MD +31107033510
Contact: A Verbon, Prof. Dr. +31107033510

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Canada, Alberta
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.   
Erasmus Medical Center Not yet recruiting
Rotterdam, Zuid Holland, Netherlands, 3015 CN
Contact: A Verbon, Prof. Dr.   
Uppsala University, Dept of Medical Sciences Not yet recruiting
Uppsala, Sweden, 751 85
Contact: T Tängdén, MD, PhD   
Geneva University Hospitals Not yet recruiting
Geneva, GE, Switzerland, 1211
Contact: B D Huttner, MD, MS   
Sponsors and Collaborators
Annelies Verbon
Erasmus Medical Center
University Hospital, Geneva
Uppsala University Hospital
University of Calgary Cumming School of Medicine
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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

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Responsible Party: Annelies Verbon, Prof. dr., Erasmus Medical Center Identifier: NCT03793946     History of Changes
Other Study ID Numbers: ZonMw_549003001
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Annelies Verbon, Erasmus Medical Center:
Drug Resistance, Microbial
Multicenter Study
Decision Support Systems, Clinical

Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents