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Completed

NCT Number: NCT00144040

Improving Antibiotic Use in Acute Care Treatment

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.

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Key information

Conditions

Respiratory Infections Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physician & patient education on appropriate antibiotic use

Behavioral

Rapid C-reactive protein testing to guide antibiotic treatment

Procedure

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

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Improving Antibiotic Use in Acute Care Setting

Acronym: IMPAACT

Important dates

Study start
2004
Study completion
2007
First posted
Sep 2, 2005
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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