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

Condition	Intervention
Community acquired Pneumonia Acute Exacerbation of Chronic Bronchitis or COPD	Behavior: Professional education  Behavior: Implementation of a Critical Care Pathway  Behavior: Professional audit and feedback  Behavior: Process analysis and redesign

Further Study Details: 

Primary Outcomes: adherence to key quality indicators for antibiotic use in Lower respiratory Tract Infections (indicators were developped from current (inter)national guideline recommendations and a sysetematic review of the literature)
Secondary Outcomes: cost; process evaluation: how well was the intervention performed; lenght of hospital stay; in hospital mortality; ICU-transfer; 30 day re-admission rate
Expected Total Enrollment:  2000

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.

We performed a cluster randomised controlled trial, to study the effect of a multifaceted intervention strategy on the quality of antibiotic use for LRTI. Our 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

- each patient admitted to a respiratory care or internal medicine ward with Community-acquired pneumonia or Acute exacerbation of Chronic Bronchitis or COPD

Exclusion Criteria:

• recent (< 30days) 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).

Netherlands
      Bernhoven Ziekenhuis, Oss,  Netherlands
      Bernhoven Ziekenhuis, Veghel,  Netherlands
      Maxima Medisch Centrum, VELDHOVEN,  Netherlands
      Deventer Ziekenhuis, Deventer,  Netherlands
      Gelre Ziekenhuizen, Apeldoorn,  Netherlands
      Ziekenhuis Gelderse Vallei, Ede,  Netherlands
      Vie Curi Medisch Centrum, Venlo,  Netherlands

Study chairs or principal investigators

Marlies E Hulscher, MSc, PhD,  Principal Investigator,  Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre   
Richard P Grol, MSc, PhD,  Study Director,  Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre   
Jos WM van der Meer, MD, PhD,  Study Director,  Department of General Internal Medicine, Radboud University Nijmegen Medical Centre   

Study ID Numbers:  AGAR-2001-1; ZonMw grant no. 2300.0024
Last Updated:  August 11, 2005
Record first received:  August 11, 2005
ClinicalTrials.gov Identifier:  NCT00129883
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-23