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Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis

Primary Purpose

Bronchitis, Cough

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Demonstration of near zero antibiotic prescribing for patients with acute bronchitis
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bronchitis focused on measuring Antibiotic, Antimicrobial, Prescribing, Cough, Acute Bronchitis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brigham and Women's Hospital Jen Center for Primary Care

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention Arm

Arm Description

Single arm in the study of doctors receiving feedback about their antibiotic prescribing rate for acute bronchitis.

Outcomes

Primary Outcome Measures

Antibiotic prescribing rate
The antibiotic prescribing rate for patients with acute bronchitis

Secondary Outcome Measures

Patient symptoms
Patient satisfaction
Patient safety
Healthcare costs
The capture and description of the components that had the greatest effect on the antimicrobial prescribing rate

Full Information

First Posted
November 10, 2010
Last Updated
January 30, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01240174
Brief Title
Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis
Official Title
Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchitis, Cough
Keywords
Antibiotic, Antimicrobial, Prescribing, Cough, Acute Bronchitis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Other
Arm Description
Single arm in the study of doctors receiving feedback about their antibiotic prescribing rate for acute bronchitis.
Intervention Type
Behavioral
Intervention Name(s)
Demonstration of near zero antibiotic prescribing for patients with acute bronchitis
Intervention Description
A controlled, continuously-monitored, implementation of an EHR-integrated diagnosis and treatment algorithm for acute bronchitis in a large, diverse primary care practice.
Primary Outcome Measure Information:
Title
Antibiotic prescribing rate
Description
The antibiotic prescribing rate for patients with acute bronchitis
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Patient symptoms
Time Frame
21 days
Title
Patient satisfaction
Time Frame
21 days
Title
Patient safety
Time Frame
30 days
Title
Healthcare costs
Time Frame
30 days
Title
The capture and description of the components that had the greatest effect on the antimicrobial prescribing rate
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Linder, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital Jen Center for Primary Care
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis

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