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

Sponsor
Annelies Verbon (Other)
Overall Status
Unknown status
CT.gov ID
NCT03793946
Collaborator
Erasmus Medical Center (Other), University Hospital, Geneva (Other), Uppsala University Hospital (Other), University of Calgary Cumming School of Medicine (Other)
1,080
4
2
16
270
16.9

Study Details

Study Description

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
  • Other: AB-assistant
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1080 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
International, multicenter stepped-wedge cluster randomized trialInternational, 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
Anticipated Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Appropriate empirical antimicrobial therapy [12 months]

    According to predefined criteria

Secondary Outcome Measures

  1. Total prescription of antimicrobial drugs [12 months]

    In defined daily dose (DDD)/admission

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

    Per AWaRe category in DDD/admission

  3. Antimicrobial costs [12 months]

    Total costs of antimicrobial drugs administered

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

    (LOS)

  5. In-hospital mortality [12 months]

    All cause in-hospital mortality

  6. Hospital readmission within 30 days of discharge [12 months]

    Unplanned hospital readmissions within 30 days after discharge

  7. Transfer to intermediate care or ICU [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) [12 months]

    Incidence of healthcare facility onset Clostridium difficile

  9. Incident clinical cultures with multi-drug resistant organisms (MDRO) [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 [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 [12 months]

    Questionnaire

  12. Number of infectious diseases consultations [12 months]

    Total amount of infectious diseases consultations

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Calgary Cumming School of Medicine and Alberta Health Services, Department of Medicine Calgary Alberta Canada T2N 2TN
2 Erasmus Medical Center Rotterdam Zuid Holland Netherlands 3015 CN
3 Uppsala University, Dept of Medical Sciences Uppsala Sweden 751 85
4 Geneva University Hospitals Geneva GE Switzerland 1211

Sponsors and Collaborators

  • Annelies Verbon
  • Erasmus Medical Center
  • University Hospital, Geneva
  • Uppsala University Hospital
  • University of Calgary Cumming School of Medicine

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Annelies Verbon, Prof. dr., Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT03793946
Other Study ID Numbers:
  • ZonMw_549003001
First Posted:
Jan 4, 2019
Last Update Posted:
Aug 4, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Annelies Verbon, Prof. dr., Erasmus Medical Center

Study Results

No Results Posted as of Aug 4, 2020