NCT01315626

Brief Summary

A study of an educational intervention of primary care practice physicians to assist in the identification of patients who have Bronchiectasis and to assess the effectiveness of the specific didactic educational intervention targeting primary care physicians in the recognition of Bronchiectasis.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 20, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2011

Enrollment Period

1 month

First QC Date

December 20, 2010

Last Update Submit

March 17, 2015

Conditions

Keywords

Bronchiectasispulmonary exacerbationspulmonary infections

Outcome Measures

Primary Outcomes (1)

  • Number / Percent of BE patients

    The primary outcome for this study will be the number/proportion of patients that meet entrance criteria that are subsequently diagnosed with bronchiectasis.

    18 months

Secondary Outcomes (1)

  • HRCT patients

    18 months

Study Arms (3)

Immediately preceding intervention

3 months immediately before the education event. Charts of patients with a primary respiratory complaint will be reviewed so evaluate if they 1) have experienced 3 or more suppurative respiratory infections and 2) have required 3 or more courses of antibiotic therapy for respiratory infection over the period of one year. 4) Whether or not they underwent a HRCT, and if so, and 5) Were the patients diagnosed with BE.

3 months after educational event

3 months immediately after the education event. An active assessment will be preformed as per the proposed diagnostic algorithm (attachment B) Patients that meet all criteria in the algorithm are considered at risk for bronchiectasis and based on these criteria, physicians will be encouraged to order HRCT, and the number/ proportion of patients identified with BE will be noted and compared to the other time periods.

Other: Primary Care Educational event

Seasonal prior year

As respiratory illnesses are commonly seasonal, an assessment of rate of Bronchiectasis diagnosis during the months of Period 2 in the year prior to the educational intervention will also be assessed as described in Period 1

Other: Primary Care Educational event

Interventions

The purpose of this study is to assess the accuracy of primary care physicians in diagnosing BE and evaluate the impact of an educational intervention targeting those primary care physicians and providing instruction in the recognition and treatment of BE. The hope is that a better understanding of the disease will result in more accurate diagnoses and ultimately in more appropriate care for these patients. In addition to better care for patients, earlier recognition of bronchiectasis may result in a decrease in health care costs.

3 months after educational eventSeasonal prior year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who present, or who have been seen in the above time periods, to the participating primary care physician with the following inclusion / exclusion criteria will be enrolled.

You may qualify if:

  • Respiratory is the chief complaint
  • Patient \> 35 years of age
  • Seen in practice for \> 12 months

You may not qualify if:

  • \) Prior diagnosis with bronchiectasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Howard Rupard, MD Primary Care Practice

Shelbyville, Tennessee, 37160, United States

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2010

First Posted

March 15, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 18, 2015

Record last verified: 2011-03

Locations