Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis

January 30, 2017 updated by: Jeffrey A. Linder, Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital Jen Center for Primary Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic prescribing rate
Time Frame: 30 days
The antibiotic prescribing rate for patients with acute bronchitis
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Jeffrey A Linder, MD, MPH, Brigham and Women's Hospital, Harvard Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 15, 2010

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010P001247

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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