Antimicrobial Stewardship Interventions in a Hospital Setting
- Conditions
- Infectious Disease
- Interventions
- Other: Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions
- Registration Number
- NCT04001309
- Lead Sponsor
- Uppsala University
- Brief Summary
The emerging crisis of multidrug-resistant bacteria is accelerated by a massive overuse and misuse of antibiotics. It has been estimated that 50% of antibiotic prescriptions are inappropriate. Antibiotic interventions to improve prescribing patterns have been successfully implemented in primary care in Sweden and other countries. However, much of the last-resort antibiotics are used in hospitals in which decisions on therapy for bacterial infections are more complex. In this project we will explore the appropriateness of antibiotic prescribing in a hospital setting and measures to improve the quality of antimicrobial therapy. Antimicrobial stewardship interventions will be conducted at selected hospital departments using prospective audit and feedback in a multifaceted and cross-disciplinary approach. The intervention effects on antibiotic consumption, appropriateness of prescriptions, patient outcome and emergence of resistance will be evaluated, and a financial cost-effectiveness analysis will be performed.
- Detailed Description
Background: In this project we will address the issue of inappropriate antibiotic prescribing in a hospital setting using a systematic and cross-disciplinary approach. We believe that a substantial reduction in antibiotic use and a significant improvement in prescribing patterns can be achieved, which will benefit the patients by reducing the risks of side effects such as antibiotic-induced Clostridium difficile enteritis.
Aim: The aim of this study is to implement and evaluate antibiotic interventions at targeted hospital wards.
Method: Hospital wards will be randomised to one of two antimicrobial stewardship intervention arms stratified by specialty (medicine or surgery). Prospective audit and feedback is a core intervention strategy in both arms.
Statistics: Interrupted time-series analysis (ITS) will be used for the primary endpoint; volume of antimicrobial prescribing. Monthly baseline data at least five years prior to start of the intervention and a during a follow-up period of at least 12 months after end of the intervention period will be used to assess immediate and sustained effects.
Endpoints and outcomes:
* Primary endpoint is reduction in antibiotic use, days of antibiotic therapy (DOTs)/100 patient days
* Secondary endpoints include outcome measures for quantity of antibiotic use, appropriateness of prescriptions, clinical and microbiological outcome and cost-effectiveness.
Data on antibiotic use and trends in prescriptions of key antibiotics will be obtained from hospital pharmacies. Data on duration of hospitalization, patient mortality, re-admissions and side effects including antibiotic-associated Clostridium difficile enteritis will be extracted from the medical records to assess potential impact on patient outcome caused by the intervention. Data on emergence of resistance during therapy and general trends in resistance epidemiology will be recorded. The outcome assessment will include a survey to participating physicians on the value different aspects of the stewardship intervention in their daily care of patients with infections. A cost-effectiveness analysis of the intervention will be performed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1312
- At least 18 years of age
- Ongoing antimicrobial therapy on a study ward
- Signed informed consent
- Patients in palliative care with very short life expectancy
- Patients from another county than study site
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infectious diseases physician led Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions Prospective audit and feedback of antimicrobial therapy by infectious disease physicians twice weekly Also including standard of care * infectious disease consultant on demand * hospital antimicrobial stewardship program as usual (education, general information, feedback on prescribing) Multiprofessional team Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions Prospective audit and feedback of antimicrobial therapy by infectious disease physicians once weekly, ward clinical pharmacists thrice weekly and engagement of ward nurses in the stewardship intervention Also including standard of care * infectious disease consultant on demand * hospital antimicrobial stewardship program as usual (education, general information, feedback on prescribing)
- Primary Outcome Measures
Name Time Method Change and trends in days of antibiotic therapy (DOT)/100 patient days 7 years Monthly DOT of antibiotics per 100 patient days on ward level assessed 5 y pre-intervention and 1 y post-intervention. Data will be analysed using interrupted time series analysis to assess immediate changes following implementation and comparison of trends before and after the intervention.
- Secondary Outcome Measures
Name Time Method Intensive Care Unit (ICU) transfer 12 months Proportion of admissions transferred to ICU after initial non-ICU admission
Appropriate diagnostic examinations 12 months Proportion of patients with appropriate diagnostic examinations performed, according to local guidelines, or in the absence of local guidelines national guidelines
Dose adjustment for renal function within 48 h after initiation of antimicrobial therapy at admission 12 months Dose adjustment of antimicrobial after the most critical phase of the infection
Therapeutic drug monitoring (TDM) 12 months Proportion of patients where TDM was used, when applicable according to local guideline
Drug-drug interactions (DDI) 12 months Important DDI taken into account when prescribing antimicrobial therapy
Costs of administered antimicrobials 12 months Costs of administered antimicrobials (overall and by class) per admission and per patient receiving antibiotics
Costs of the intervention 12 months Total costs of the intervention
Treatment duration (Days per treatment period overall) 12 months Overall days per treatment episode. A treatment episode is defined as antimicrobial treatment not interrupted by more than one calendar day.
In-hospital mortality 12 months All-cause in-hospital mortality
Hospital length of stay (LOS) 12 months Hospital length of stay per admission
Intravenous to oral switch 12 months Proportion of patients where intravenous antibiotics was shifted to oral therapy within 5 days (if appropriate)
Dose adjustment for renal function when initiating antimicrobial therapy in a non-acute situation 12 months Proportion of antimicrobial prescription in non-acute situations where dosing was according to renal function
Days of defined daily doses (DDDs)/100 patient days 12 months Overall days of therapy per 100 patient days (PD) on the ward level
30-d mortality 12 months All cause 30-d mortality
Hospital readmission within 30 d after discharge 12 months Unplanned hospital readmission within 30 d after discharge
Hospital readmission due to relapse of infection within 30 d after discharge 12 months Unplanned hospital readmission due to relapse of infection within 30 d after discharge
Guideline compliance 12 months Proportion of patients treated where antimicrobial therapy was in compliance with local guideline, or in absence of local guideline national guideline
De-escalation or shift to targeted therapy 12 months Proportion of patients where de-escalation or shift to targeted antibiotic therapy occurred within 72 hours after initiation of treatment
Incidence of multidrug-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 PD and admissions
Incidence of Clostridium difficile infections (CDI) 12 months Incidence of healthcare-facility onset CDI denominated by 10 000 PD and admission
Trial Locations
- Locations (2)
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Ystads lasarett
🇸🇪Ystad, Sweden