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Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01240174
First Posted: November 15, 2010
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Jeffrey A. Linder, Brigham and Women's Hospital
  Purpose
Studies show, guidelines state, and performance measures assert that antibiotic prescribing for uncomplicated acute bronchitis is inappropriate. However, clinicians prescribe antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the United States each year. Previous successful interventions have only reduced the antimicrobial prescribing rate to 40% or 50%. It is unknown if the antimicrobial prescribing rate for acute bronchitis can be brought to near zero percent in actual practice while maintaining patient safety and satisfaction. The goal of this study is to develop an Electronic Health Record (EHR)-integrated algorithm for the diagnosis and treatment of adults with acute bronchitis with a goal of reducing the antibiotic prescribing rate to near zero percent.

Condition Intervention
Bronchitis Cough Behavioral: Demonstration of near zero antibiotic prescribing for patients with acute bronchitis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis

Resource links provided by NLM:


Further study details as provided by Jeffrey A. Linder, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Antibiotic prescribing rate [ Time Frame: 30 days ]
    The antibiotic prescribing rate for patients with acute bronchitis


Secondary Outcome Measures:
  • Patient symptoms [ Time Frame: 21 days ]
  • Patient satisfaction [ Time Frame: 21 days ]
  • Patient safety [ Time Frame: 30 days ]
  • Healthcare costs [ Time Frame: 30 days ]
  • The capture and description of the components that had the greatest effect on the antimicrobial prescribing rate [ Time Frame: 3 years ]

Enrollment: 400
Study Start Date: March 2011
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention Arm
Single arm in the study of doctors receiving feedback about their antibiotic prescribing rate for acute bronchitis.
Behavioral: Demonstration of near zero antibiotic prescribing for patients with acute bronchitis
A controlled, continuously-monitored, implementation of an EHR-integrated diagnosis and treatment algorithm for acute bronchitis in a large, diverse primary care practice.

Detailed Description:
We will use a multi-modal implementation - including computerized decision support, reporting tools, and clinician feedback - and quality improvement techniques to ensure adherence to the algorithm and reduce the antimicrobial prescribing rate to near zero percent. The duration of the intervention will be 4 years.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • first visit in 30 days, age 18-64, has a cough of less than 3 weeks duration

Exclusion Criteria:

  • infiltrate on chest x-ray, has chronic lung disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240174


Locations
United States, Massachusetts
Brigham and Women's Hospital Jen Center for Primary Care
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Jeffrey A Linder, MD, MPH Brigham and Women's Hospital, Harvard Medical School
  More Information

Responsible Party: Jeffrey A. Linder, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01240174     History of Changes
Other Study ID Numbers: 2010P001247
First Submitted: November 10, 2010
First Posted: November 15, 2010
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by Jeffrey A. Linder, Brigham and Women's Hospital:
Antibiotic
Antimicrobial
Prescribing
Cough
Acute Bronchitis

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents