Improving Antibiotic Use in Acute Care Treatment

Not Applicable

Completed

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

• Registration Number: NCT00144040
• Lead Sponsor: US Department of Veterans Affairs

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Study Completion: 2007-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 1	Physician & patient education on appropriate antibiotic use	-
Arm 1	Rapid C-reactive protein testing to guide antibiotic treatment	-

Primary Outcome Measures

Name	Time	Method
Proportion of all acute respiratory infection visits treated with antibiotics

Secondary Outcome Measures

Name	Time	Method
Delayed antibiotic treatment of acute respiratory infections; Patient satisfaction

Trial Locations

Locations (9)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States

Edward Hines Jr. VA Hospital, Hines, IL; 🇺🇸 Hines, Illinois, United States

Charlie Norwood VA Medical Center, Augusta, GA; 🇺🇸 Augusta, Georgia, United States

Kansas City VA Medical Center, Kansas City, MO; 🇺🇸 Kansas City, Missouri, United States

New Mexico VA Health Care System, Albuquerque, NM; 🇺🇸 Albuquerque, New Mexico, United States

James J. Peters VA Medical Center, Bronx, NY; 🇺🇸 Bronx, New York, United States

Philadelphia VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; 🇺🇸 Pittsburgh, Pennsylvania, United States

South Texas Health Care System, San Antonio, TX; 🇺🇸 San Antonio, Texas, United States