Antimicrobial Stewardship Interventions in a Hospital Setting

NCT04001309 | Completed

• 1 other identifier: Dnr 2018-423
• Study Type: interventional
• Target: 1,312
• Locations: 1 country
• Sites: 2

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.

Conditions

Infectious Disease

Keywords

antimicrobial stewardship; prospective audit and feedback; infectious diseases; randomized trial

Outcome Measures

Primary Outcomes (1)

• Change and trends in days of antibiotic therapy (DOT)/100 patient days

  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.

  7 years

Secondary Outcomes (20)

• Days of defined daily doses (DDDs)/100 patient days

  12 months

• Treatment duration (Days per treatment period overall)

  12 months

• 30-d mortality

  12 months

• In-hospital mortality

  12 months

• Hospital readmission within 30 d after discharge

  12 months

Study Arms (2)

Infectious diseases physician led

EXPERIMENTAL

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)

Other: Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions

Multiprofessional team

EXPERIMENTAL

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)

Other: Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions

Interventions

Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions OTHER

Prospective audit and feedback of antimicrobial therapy at hospital wards, by interventions performed by infectious diseases specialists alone or using a team-based approach.

Infectious diseases physician led; Multiprofessional team

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Ongoing antimicrobial therapy on a study ward
• Signed informed consent

You may not qualify if:

• Patients in palliative care with very short life expectancy
• Patients from another county than study site

Sponsors & Collaborators

• Uppsala University: lead
• Lund University: collaborator

Study Sites (2)

Uppsala University Hospital

Uppsala, Sweden

Location

Ystads lasarett

Ystad, Sweden

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Tängdén, MD, Phd

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking for care providers and investigators is not feasible. Outcomes assessors will be blinded to study period and intervention arms when evaluating appropriateness of prescribing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 28, 2019
• Study Start: July 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Locations

SE (2)