Bronchiectasis: Evaluation of an Educational Intervention

This study has been withdrawn prior to enrollment.
(Sponsor did not move forward with study)
Sponsor:
Information provided by:
Hill-Rom
ClinicalTrials.gov Identifier:
NCT01315626
First received: December 20, 2010
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Bronchiectasis
Other: Primary Care Educational event

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Identification of Patients With a Diagnosis of Bronchiectasis: Evaluation of an Educational Intervention

Further study details as provided by Hill-Rom:

Primary Outcome Measures:
  • Number / Percent of BE patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The primary outcome for this study will be the number/proportion of patients that meet entrance criteria that are subsequently diagnosed with bronchiectasis.


Secondary Outcome Measures:
  • HRCT patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Secondary outcomes are the number/proportion of those subjects that undergo HRCT, and the number/proportion of subjects that are then identified as having Bronchiectasis.


Estimated Enrollment: 10000
Study Start Date: January 2011
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
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
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.

Detailed Description:

A pilot study will be conducted for the purpose of evaluating an educational intervention (Description in Appendix A). As part of the educational intervention, primary care physician(s) will be trained in the use of an algorithm to guide assessment of patients seen with a respiratory chief complaint, and who have not previously been identified as having a diagnosis of BE. We propose an evaluation of three primary care practice(s) to compare the number of patients identified in three three-month periods as having a diagnosis of BE.

The evaluation periods will be as follows: Period 1) the three-month period immediately following the intervention, Period 2) the three-month period immediately preceding the intervention, Period 3) the three month period starting one year prior to the intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  1. Respiratory is the chief complaint
  2. Patient > 35 years of age
  3. Seen in practice for > 12 months

Exclusion Criteria:

1) Prior diagnosis with bronchiectasis

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315626

Locations
United States, Tennessee
Howard Rupard, MD Primary Care Practice
Shelbyville, Tennessee, United States, 37160
Sponsors and Collaborators
Hill-Rom
  More Information

No publications provided

Responsible Party: Frederic D. Seifer, MD, FCCP, Seifer Pulmononogy
ClinicalTrials.gov Identifier: NCT01315626     History of Changes
Other Study ID Numbers: CR-2010-04
Study First Received: December 20, 2010
Last Updated: March 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Hill-Rom:
Bronchiectasis
pulmonary exacerbations
pulmonary infections

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014