Improving Antibiotic Use in Acute Care Treatment (IMPAACT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00144040
First received: August 31, 2005
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Improving Antibiotic Use in Acute Care Setting

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Proportion of all acute respiratory infection visits treated with antibiotics [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delayed antibiotic treatment of acute respiratory infections; Patient satisfaction [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: February 2004
Study Completion Date: July 2007
Arms Assigned Interventions
Arm 1 Behavioral: Physician & patient education on appropriate antibiotic use Procedure: Rapid C-reactive protein testing to guide antibiotic treatment

Detailed Description:

Objectives:

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.

Methods:

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.

  Eligibility

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

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
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: NCT00144040

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
United States, Georgia
VA Medical Center, Augusta
Augusta, Georgia, United States, 30904-6285
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, Missouri, United States, 64128
United States, New Mexico
New Mexico VA Health Care System
Albuquerque, New Mexico, United States, 87108-5153
United States, New York
James J Peters VA Medical Center
Bronx, New York, United States, 10468
United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Center for Health Equity Research and Promotion
Pittsburgh, Pennsylvania, United States, 15240-1000
United States, Texas
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Investigators
Principal Investigator: Joshua P. Metlay, MD PhD Center for Health Equity Research and Promotion
  More Information

Additional Information:
Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00144040     History of Changes
Other Study ID Numbers: AVA 03-239, R01 HF13915
Study First Received: August 31, 2005
Last Updated: April 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Antibiotics
Respiratory Infections
Quality Assurance, Healthcare
Professional Education
Emergency Services, Medical
Education, Patient

Additional relevant MeSH terms:
Infection
Respiratory Tract Infections
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014