Clinical trial NCT03793946: A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant
Official title: A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant: an International, Multicenter Stepped-wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anti-Infective Agents
Mobile Applications
Quality Improvement
Antimicrobial Stewardship
Keywords: Drug Resistance, Microbial
Multicenter Study
Decision Support Systems, Clinical
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: University Hospital, Geneva
name: Uppsala University Hospital
name: University of Calgary Cumming School of Medicine
First posted: 2019-01-04
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: International, multicenter stepped-wedge cluster randomized trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Appropriate empirical antimicrobial therapy
timeFrame: 12 months
Secondary outcomes:
measure: Total prescription of antimicrobial drugs
timeFrame: 12 months
measure: Total prescription of antimicrobial drugs per AWaRe category in DDD/admission
timeFrame: 12 months
measure: Antimicrobial costs
timeFrame: 12 months
measure: Length of hospital stay (LOS)
timeFrame: 12 months
measure: In-hospital mortality
timeFrame: 12 months
measure: Hospital readmission within 30 days of discharge
timeFrame: 12 months
measure: Transfer to intermediate care or ICU
timeFrame: 12 months
measure: Incidence Clostridium difficile infections (CDI)
timeFrame: 12 months
measure: Incident clinical cultures with multi-drug resistant organisms (MDRO)
timeFrame: 12 months
measure: Uptake of the AB-assistant
timeFrame: 12 months
measure: Actual use of AB-assistant and experiences while using it
timeFrame: 12 months
measure: Number of infectious diseases consultations
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Cumming School of Medicine and Alberta Health Services, Department of Medicine
state: Alberta
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid Holland
city: Uppsala
country: Sweden
facility: Uppsala University, Dept of Medical Sciences
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
state: GE
Study officials:
affiliation: University Hospital, Geneva
name: B D Huttner, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: T Tängdén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary Cumming School of Medicine
name: John Conly, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helou RI, Catho G, Peyravi Latif A, Mouton J, Hulscher M, Teerenstra S, Conly J, Huttner BD, Tangden T, Verbon A. Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application. BMJ Open. 2020 Jun 4;10(6):e033640. doi: 10.1136/bmjopen-2019-033640.