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Improving Antibiotic Use in Acute Care Treatment (IMPAACT)

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ClinicalTrials.gov Identifier: NCT00144040
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Purpose The emergence and rapid rise in antibiotic resistance among common bacteria are adversely affecting the clinical course and health care costs of community-acquired infections. Because antibiotic resistance rates are strongly correlated with antibiotic use patterns, multiple organizations have declared reductions in unnecessary antibiotic use to be critical components of efforts to combat antibiotic resistance. Among humans, the vast majority of unnecessary antibiotic prescriptions are used to treat acute respiratory tract infections (ARIs) that have a viral etiology. Although the rate of antibiotic prescribing for ARIs by office-based physicians in the US has decreased about 16% from its peak in 1997, the rate of antibiotic prescribing in acute care settings (eg, emergency departments and urgent care centers), which account for 1 in 5 ambulatory antibiotic prescriptions in the US, has shown only a modest decline (6%) during this period. Translation of lessons from intervention studies in office-based practices is needed to improve antibiotic use in acute care settings.

Condition or disease Intervention/treatment
Respiratory Infections Behavioral: Physician & patient education on appropriate antibiotic use Procedure: Rapid C-reactive protein testing to guide antibiotic treatment

Detailed Description:


Specific Aim 1: To evaluate the impact of a multidimensional (patient, system, clinician) intervention on appropriate antibiotic use for adults with acute respiratory tract infections-- identifying factors that influence successful translation across VA hospital and non-VA hospital acute care. Specific Aim 2: To evaluate the impact of a rapid diagnostic test for c-reactive protein on antibiotic use for adults with acute cough illness when added to a multidimensional intervention.


We propose to conduct a randomized controlled trial of a quality improvement program consisting of physician education (educational seminar, practice guidelines, performance feedback, and decision support tools) and patient education (waiting room print and audiovisual materials) in 8 VA hospital and 8 non-VA hospital emergency departments. Non VA study sites will be identified from an existing research network of hospital emergency departments--EDNet. VA hospital sites will be selected among academically affiliated hub facilities. Phase one will involve a hospital-level randomized trial of a multidimensional intervention to translate existing evidence based guidelines for antibiotic use in ARIs vs. usual care. Simultaneously, we will validate a new CRP-based diagnostic algorithm and incorporate it into the evidence based guidelines for antibiotic use in ARIs. Phase two will involve a second hospital-level randomized trial of the new antibiotic use guidelines that incorporate the CRP-based diagnostic algorithm vs. the original guidelines. Specific endpoints include the overall success of the intervention in each phase in terms of reducing antibiotic prescribing for ARIs, improving patient outcomes and reducing resource utilization. In addition we will examin the impact of VA and non-VA organizational factors on the successful translation of various components of the intervention in both phases. Data will be collected using existing administrative data as well as on-site enrollment of subjects in prospective follow-up studies.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Improving Antibiotic Use in Acute Care Setting
Study Start Date : February 2004
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Arm 1 Behavioral: Physician & patient education on appropriate antibiotic use Procedure: Rapid C-reactive protein testing to guide antibiotic treatment

Outcome Measures

Primary Outcome Measures :
  1. Proportion of all acute respiratory infection visits treated with antibiotics

Secondary Outcome Measures :
  1. Delayed antibiotic treatment of acute respiratory infections; Patient satisfaction

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Emergency room patient
  • Selected VA or Non-VA patients
  • Age 18 years or older
  • Patient must have acute respiratory illness
  • Patient must not have been seen in Emergency Department within 4 weeks

Exclusion Criteria:

  • Patients less than 18 years of age
  • Patient in Emergency Department for non-acute respiratory infection
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144040

United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
United States, Georgia
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, United States, 30904
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
United States, Missouri
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States, 64128
United States, New Mexico
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States, 87108-5153
United States, New York
James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, United States, 10468
United States, Pennsylvania
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
VA Office of Research and Development
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Joshua P. Metlay, MD PhD Philadelphia VA Medical Center, Philadelphia, PA
More Information


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00144040     History of Changes
Other Study ID Numbers: AVA 03-239
R01 HF13915
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by VA Office of Research and Development:
Respiratory Infections
Quality Assurance, Healthcare
Professional Education
Emergency Services, Medical
Education, Patient

Additional relevant MeSH terms:
Respiratory Tract Infections
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents