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C-reactive Protein (CRP)-Guided Management Algorithm for Adults With Acute Cough

This study has been completed.
Sponsor:
Collaborators:
Department of Veterans Affairs
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00221351
First received: September 19, 2005
Last updated: May 20, 2011
Last verified: May 2011
History of Changes
  Purpose

We aim to evaluate the impact of a CRP-guided management algorithm for adults with acute cough illness. More specifically, we will examine both process of care and clinical outcomes:

  1. Processes of care (i.e., chest x-rays ordered, antibiotic treatment, length-of-time in the ED). We hypothesize that CRP-guided management will be associated with a decrease in the antibiotic prescription for acute cough illness from 50 percent to 30 percent.
  2. Clinical outcomes (i.e., duration of illness, any return visit, return visit with a diagnosis of pneumonia, hospitalization, subsequent antibiotic use, satisfaction with care). We hypothesize that there will be no difference in the proportion of patients feeling back to normal within 2 weeks of their ED visit for acute cough illness (about 60 percent, 95% confidence interval=50 to 70 percent).

Condition Intervention
Cough
 Procedure: CRP point of care testing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized, Controlled Trial of a C-reactive Protein (CRP)-Guided Management Algorithm for Adults With Acute Cough Illness in the Emergency Department

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Chest X-ray utilization, Antibiotic treatment, Time in emergency department, Subsequent office or emergency department visits (within 2 weeks; Subsequent hospitalization, Time-to-illness resolution

Secondary Outcome Measures:
  • Satisfaction with care

Enrollment: 139
Study Start Date: October 2005
Study Completion Date: July 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (age > 18 years) seeking care for an acute respiratory illness (duration < 10 days) in which cough is a chief complaint.
  • Eligible patients will be required to have at least 1 symptom of acute respiratory tract infection (fever, night sweats, rhinorrhea, sinus congestion, myalgias).

Exclusion Criteria:

  • Previous (within 21 days) antibiotic treatment;
  • immunodeficiency;
  • cystic fibrosis;
  • patient requiring immediate evaluation/management;
  • inability to provide informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221351

Locations
United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
University of California, San Francisco
Department of Veterans Affairs
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Ralph Gonzales, MD University of California, San Francisco
Principal Investigator: Joshua Metlay, MD VAMC Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221351     History of Changes
Other Study ID Numbers: CRP-1, IMPAACT- AHRQ/ VAMC
Study First Received: September 19, 2005
Last Updated: May 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
cough
acute bronchitis
upper respiratory tract infection
pneumonia
lower respiratory tract infection

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013