NCT00144040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

First QC Date

August 31, 2005

Last Update Submit

April 6, 2015

Conditions

Keywords

AntibioticsRespiratory InfectionsQuality Assurance, HealthcareProfessional EducationEmergency Services, MedicalEducation, Patient

Outcome Measures

Primary Outcomes (1)

  • Proportion of all acute respiratory infection visits treated with antibiotics

Secondary Outcomes (1)

  • Delayed antibiotic treatment of acute respiratory infections; Patient satisfaction

Study Arms (1)

Arm 1

OTHER
Behavioral: Physician & patient education on appropriate antibiotic useProcedure: Rapid C-reactive protein testing to guide antibiotic treatment

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Charlie Norwood VA Medical Center, Augusta, GA

Augusta, Georgia, 30904, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri, 64128, United States

Location

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

Related Publications (7)

  • 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. doi: 10.1197/j.aem.2005.01.012.

  • 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. doi: 10.1197/j.aem.2005.10.016.

  • 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. doi: 10.1197/j.aem.2006.10.096. Epub 2007 Feb 12.

  • 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.

  • 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 Emerg Med. 2007 Sep;50(3):221-30. doi: 10.1016/j.annemergmed.2007.03.022. Epub 2007 May 23.

  • 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. doi: 10.1016/j.ajem.2006.11.031.

  • 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. doi: 10.1197/j.aem.2007.01.022. Epub 2007 Apr 30.

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Physicians

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Joshua P. Metlay, MD PhD

    Philadelphia VA Medical Center, Philadelphia, PA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

February 1, 2004

Study Completion

July 1, 2007

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations