Clinical trial NCT00129883: Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals
Official title: Prevention of Antimicrobial Resistance in Hospitals: Promoting Appropriate Use of Antibiotics in Hospital Departments of Internal and Pulmonary Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Chronic Bronchitis
COPD
Keywords: quality of care
antibiotic use
intervention
lower respiratory tract infections
Community acquired Pneumonia
Acute Exacerbation of Chronic Bronchitis or COPD
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-08-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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 outcomes:
measure: cost
measure: process evaluation: how well was the intervention performed
measure: length of hospital stay
measure: in-hospital mortality
measure: Intensive Care Unit (ICU)-transfer
measure: 30 day re-admission rate
Other outcomes:
Locations:
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Oss
country: Netherlands
facility: Bernhoven Ziekenhuis
city: Veghel
country: Netherlands
facility: Bernhoven Ziekenhuis
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Venlo
country: Netherlands
facility: Vie Curi Medisch Centrum
Study officials:
affiliation: Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
name: Marlies E Hulscher, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
name: Richard P Grol, MSc, PhD
role: STUDY_DIRECTOR
affiliation: Department of General Internal Medicine, Radboud University Nijmegen Medical Centre
name: Jos WM van der Meer, MD, PhD
role: STUDY_DIRECTOR
References: