NCT00981994

Brief Summary

Inappropriate use of antibiotics to treat patients with acute bronchitis is a significant factor contributing to the selection of antimicrobial drug resistant pathogens, which threaten the effectiveness of available therapies to treat common community-acquired bacterial infections. A key factor driving overuse of antibiotics is inaccurate estimation of pneumonia risk among patients with acute cough illnesses. This study will use a cluster randomized trial design within the Geisinger Health System's integrated clinic network to measure the efficacy of an algorithm driven clinical decision support tool to safely reduce the frequency of unnecessary antibiotic prescriptions for adult patients with lower respiratory tract infections.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

September 14, 2009

Last Update Submit

November 23, 2016

Conditions

Keywords

respiratory infectionantimicrobial drugsdecision supportAdult patients

Outcome Measures

Primary Outcomes (1)

  • Proportion of visits to primary care clinic associated with antibiotic prescriptions

    30 days

Study Arms (3)

Electronic Decision Support

EXPERIMENTAL

Use of electronic decision support to provide the treatment algorithm for providers managing patients with acute respiratory infections.

Behavioral: Decision Support for ARI Management

Paper Decision Support

EXPERIMENTAL

Use of paper based tools to provide the treatment algorithm for providers managing patients with acute respiratory infections.

Behavioral: Decision Support for ARI Management

Usual Care

NO INTERVENTION

Usual Care

Interventions

Use of history and physical examination findings to estimate probability of pneumonia in patients with acute respiratory infections and thereby guide treatment decisions

Electronic Decision SupportPaper Decision Support

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary care practice sites within the Geisinger Health System

You may not qualify if:

  • Sites with \< 1000 visits per year for acute respiratory infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gonzales R, Anderer T, McCulloch CE, Maselli JH, Bloom FJ Jr, Graf TR, Stahl M, Yefko M, Molecavage J, Metlay JP. A cluster randomized trial of decision support strategies for reducing antibiotic use in acute bronchitis. JAMA Intern Med. 2013 Feb 25;173(4):267-73. doi: 10.1001/jamainternmed.2013.1589.

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Joshua P Metlay, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
  • Ralph Gonzales, MD,MS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 22, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2011

Study Completion

September 1, 2012

Last Updated

November 28, 2016

Record last verified: 2016-11