Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00129883
First received: August 11, 2005
Last updated: September 26, 2005
Last verified: August 2002
  Purpose

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.


Condition Intervention
Pneumonia
Chronic Bronchitis
COPD
Behavioral: Professional education
Behavioral: Implementation of a Critical Care Pathway
Behavioral: Professional audit and feedback
Behavioral: Process analysis and redesign

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Prevention of Antimicrobial Resistance in Hospitals: Promoting Appropriate Use of Antibiotics in Hospital Departments of Internal and Pulmonary Medicine

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • cost
  • process evaluation: how well was the intervention performed
  • length of hospital stay
  • in-hospital mortality
  • Intensive Care Unit (ICU)-transfer
  • 30 day re-admission rate

Estimated Enrollment: 2000
Study Start Date: September 2002
Estimated Study Completion Date: April 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129883

Locations
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, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Marlies E Hulscher, MSc, PhD Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
Study Director: Richard P Grol, MSc, PhD Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
Study Director: Jos WM van der Meer, MD, PhD Department of General Internal Medicine, Radboud University Nijmegen Medical Centre
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00129883     History of Changes
Other Study ID Numbers: AGAR-2001-1, ZonMw grant no. 2300.0024
Study First Received: August 11, 2005
Last Updated: September 26, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
quality of care
antibiotic use
intervention
lower respiratory tract infections
Community acquired Pneumonia
Acute Exacerbation of Chronic Bronchitis or COPD

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Pneumonia
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014