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Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals

Primary Purpose

Pneumonia, Chronic Bronchitis, COPD

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Professional education
Implementation of a Critical Care Pathway
Professional audit and feedback
Process analysis and redesign
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Pneumonia focused on measuring quality of care, antibiotic use, intervention, lower respiratory tract infections, Community acquired Pneumonia, Acute Exacerbation of Chronic Bronchitis or COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Gelre Ziekenhuizen
  • Deventer Ziekenhuis
  • Ziekenhuis Gelderse Vallei
  • Bernhoven Ziekenhuis
  • Bernhoven Ziekenhuis
  • Maxima Medisch Centrum
  • Vie Curi Medisch Centrum

Outcomes

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

Full Information

First Posted
August 11, 2005
Last Updated
September 26, 2005
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00129883
Brief Title
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

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Professional education
Intervention Type
Behavioral
Intervention Name(s)
Implementation of a Critical Care Pathway
Intervention Type
Behavioral
Intervention Name(s)
Professional audit and feedback
Intervention Type
Behavioral
Intervention Name(s)
Process analysis and redesign
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
cost
Title
process evaluation: how well was the intervention performed
Title
length of hospital stay
Title
in-hospital mortality
Title
Intensive Care Unit (ICU)-transfer
Title
30 day re-admission rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlies E Hulscher, MSc, PhD
Organizational Affiliation
Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard P Grol, MSc, PhD
Organizational Affiliation
Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jos WM van der Meer, MD, PhD
Organizational Affiliation
Department of General Internal Medicine, Radboud University Nijmegen Medical Centre
Official's Role
Study Director
Facility Information:
Facility Name
Gelre Ziekenhuizen
City
Apeldoorn
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
Country
Netherlands
Facility Name
Bernhoven Ziekenhuis
City
Oss
Country
Netherlands
Facility Name
Bernhoven Ziekenhuis
City
Veghel
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Facility Name
Vie Curi Medisch Centrum
City
Venlo
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.wokresearch.nl
Description
website of Centre for Quality of Care Research, department of the Radboud University Nijmegen Medical Centre, where this study was carried out

Learn more about this trial

Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals

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