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

Quality Improvement Clinical Trial

— AB-assistant  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03793946
• Other study ID #: ZonMw_549003001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: January 2022

Study information

• Verified date: July 2020
• Source: Erasmus Medical Center
• Contact: R I Helou, MD
• Phone: +31107033510
• Email: r.helou[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1080
• Est. completion date: January 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anti-Infective Agents
• Antimicrobial Stewardship
• Mobile Applications
• Quality Improvement

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary Cumming School of Medicine and Alberta Health Services, Department of Medicine	Calgary	Alberta
Netherlands	Erasmus Medical Center	Rotterdam	Zuid Holland
Sweden	Uppsala University, Dept of Medical Sciences	Uppsala
Switzerland	Geneva University Hospitals	Geneva	GE

Sponsors (5)

Lead Sponsor	Collaborator
Annelies Verbon	Erasmus Medical Center, University Hospital, Geneva, University of Calgary Cumming School of Medicine, Uppsala University Hospital

Countries where clinical trial is conducted

Canada,  Netherlands,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriate empirical antimicrobial therapy	According to predefined criteria	12 months
Secondary	Total prescription of antimicrobial drugs	In defined daily dose (DDD)/admission	12 months
Secondary	Total prescription of antimicrobial drugs per AWaRe category in DDD/admission	Per AWaRe category in DDD/admission	12 months
Secondary	Antimicrobial costs	Total costs of antimicrobial drugs administered	12 months
Secondary	Length of hospital stay (LOS)	(LOS)	12 months
Secondary	In-hospital mortality	All cause in-hospital mortality	12 months
Secondary	Hospital readmission within 30 days of discharge	Unplanned hospital readmissions within 30 days after discharge	12 months
Secondary	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
Secondary	Incidence Clostridium difficile infections (CDI)	Incidence of healthcare facility onset Clostridium difficile	12 months
Secondary	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
Secondary	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
Secondary	Actual use of AB-assistant and experiences while using it	Questionnaire	12 months
Secondary	Number of infectious diseases consultations	Total amount of infectious diseases consultations	12 months