Improving Antibiotic Use in Acute Care Treatment

Respiratory Infections Clinical Trial

— IMPAACT  

Official title:

Improving Antibiotic Use in Acute Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144040
• Other study ID #: AVA 03-239
• Secondary ID: R01 HF13915
• Status: Completed
• Phase: N/A
• First received: August 31, 2005
• Last updated: April 6, 2015
• Start date: February 2004
• Est. completion date: July 2007

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Respiratory Infections
• Respiratory Tract Infections

Intervention

Behavioral:
• Physician & patient education on appropriate antibiotic use

Procedure:
• Rapid C-reactive protein testing to guide antibiotic treatment

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System, Albuquerque, NM	Albuquerque	New Mexico
United States	Charlie Norwood VA Medical Center, Augusta, GA	Augusta	Georgia
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois
United States	Kansas City VA Medical Center, Kansas City, MO	Kansas City	Missouri
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	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Aspinall SL, Metlay JP, Maselli JH, Gonzales R. Impact of hospital formularies on fluoroquinolone prescribing in emergency departments. Am J Manag Care. 2007 May;13(5):241-8. — View Citation

Gonzales R, Camargo CA Jr, MacKenzie T, Kersey AS, Maselli J, Levin SK, McCulloch CE, Metlay JP; IMPAACT Trial Investigators. Antibiotic treatment of acute respiratory infections in acute care settings. Acad Emerg Med. 2006 Mar;13(3):288-94. — View Citation

Metlay JP, Camargo CA Jr, Bos K, Gonzales R. Assessing the suitability of intervention sites for quality improvement studies in emergency departments. Acad Emerg Med. 2005 Jul;12(7):667-70. — View Citation

Metlay JP, Camargo CA Jr, MacKenzie T, McCulloch C, Maselli J, Levin SK, Kersey A, Gonzales R; IMPAACT Investigators. Cluster-randomized trial to improve antibiotic use for adults with acute respiratory infections treated in emergency departments. Ann Eme — View Citation

Nolt BR, Gonzales R, Maselli J, Aagaard E, Camargo CA Jr, Metlay JP. Vital-sign abnormalities as predictors of pneumonia in adults with acute cough illness. Am J Emerg Med. 2007 Jul;25(6):631-6. — View Citation

Pines JM, Hollander JE, Lee H, Everett WW, Uscher-Pines L, Metlay JP. Emergency department operational changes in response to pay-for-performance and antibiotic timing in pneumonia. Acad Emerg Med. 2007 Jun;14(6):545-8. Epub 2007 Apr 30. — View Citation

Vanderweil SG, Pelletier AJ, Hamedani AG, Gonzales R, Metlay JP, Camargo CA Jr. Declining antibiotic prescriptions for upper respiratory infections, 1993-2004. Acad Emerg Med. 2007 Apr;14(4):366-9. Epub 2007 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of all acute respiratory infection visits treated with antibiotics			No
Secondary	Delayed antibiotic treatment of acute respiratory infections; Patient satisfaction			No