Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals

COPD Clinical Trial

Official title:

Prevention of Antimicrobial Resistance in Hospitals: Promoting Appropriate Use of Antibiotics in Hospital Departments of Internal and Pulmonary Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129883
• Other study ID #: AGAR-2001-1
• Secondary ID: ZonMw grant no.
• Status: Completed
• Phase: N/A
• First received: August 11, 2005
• Last updated: September 26, 2005
• Start date: September 2002
• Est. completion date: April 2005

Study information

• Verified date: August 2002
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test a strategy to improve the quality of antibiotic use in lower respiratory tract infections (LRTIs) at hospitals. Therefore, a multifaceted intervention strategy is compared to a control strategy and the effectiveness and feasibility of the intervention is assessed.

Description:

Improving processes of care in patients with hospital LRTI has been related to better patient outcome. Inappropriate use of antibiotics has contributed to the emergence and spread of drug-resistant micro organisms and increased treatment costs. International guidelines provide recommendations for the initial evaluation and management of LRTI, including advice on judicious antibiotic therapy. Nonetheless, studies have demonstrated a wide variability in adherence to these guidelines.

To implement key recommendations in clinical practice, various strategies have been used, with mixed results. Perhaps the most important aspect of choosing a potentially effective intervention is that the choice of intervention should be based upon assessment of potential barriers in the target group. Many intervention studies are flawed by failing to control for secular trends.

The investigators performed a cluster randomised controlled trial, to study the effect of a multifaceted intervention strategy on the quality of antibiotic use for LRTI. Their intervention was tailored to the areas most in need for improvement and took perceived barriers in the target group into consideration at the individual hospital level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted to a respiratory care or internal medicine ward with community-acquired pneumonia or acute exacerbation of chronic bronchitis or chronic obstructive pulmonary disease (COPD)

Exclusion Criteria:

• Recent (< 30 days) admission for LRTI

• Patients with underlying immunodeficiency (HIV infection, neutropenia, treatment with immunomodulating drugs, active hematological malignancies, anatomical or functional asplenia and hypogammaglobulinemia)

• Patients already on treatment with antibiotics for another culture proven infection at the time of admission

• Patients from nursing homes

• Patients who had been transferred to another hospital or ICU and patients who had died within 24 hours of admission

• Patients with very poor prognosis (life expectancy < 2 weeks on admission).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• COPD
• Pneumonia

Intervention

Behavioral:
• Professional education

• Implementation of a Critical Care Pathway

• Professional audit and feedback

• Process analysis and redesign

Locations

Country	Name	City	State
Netherlands	Gelre Ziekenhuizen	Apeldoorn
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Bernhoven Ziekenhuis	Oss
Netherlands	Bernhoven Ziekenhuis	Veghel
Netherlands	Maxima Medisch Centrum	Veldhoven
Netherlands	Vie Curi Medisch Centrum	Venlo

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence to key quality indicators for antibiotic use in lower respiratory tract infections (indicators were developed from current [inter]national guideline recommendations and a systematic review of the literature)
Secondary	cost
Secondary	process evaluation: how well was the intervention performed
Secondary	length of hospital stay
Secondary	in-hospital mortality
Secondary	Intensive Care Unit (ICU)-transfer
Secondary	30 day re-admission rate

External Links

•   website of Centre for Quality of Care Research, department of the Radboud University Nijmegen Medical Centre, where this study was carried out