NCT01240174

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3.3 years

First QC Date

November 10, 2010

Last Update Submit

January 30, 2017

Conditions

Keywords

AntibioticAntimicrobialPrescribingCoughAcute Bronchitis

Outcome Measures

Primary Outcomes (1)

  • Antibiotic prescribing rate

    The antibiotic prescribing rate for patients with acute bronchitis

    30 days

Secondary Outcomes (5)

  • Patient symptoms

    21 days

  • Patient satisfaction

    21 days

  • Patient safety

    30 days

  • Healthcare costs

    30 days

  • The capture and description of the components that had the greatest effect on the antimicrobial prescribing rate

    3 years

Study Arms (1)

Intervention Arm

OTHER

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

Interventions

A controlled, continuously-monitored, implementation of an EHR-integrated diagnosis and treatment algorithm for acute bronchitis in a large, diverse primary care practice.

Intervention Arm

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • infiltrate on chest x-ray, has chronic lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital Jen Center for Primary Care

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

BronchitisCough

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey A Linder, MD, MPH

    Brigham and Women's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 15, 2010

Study Start

March 1, 2011

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations