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Interstitial Lung Diseases in the Veterans Administration

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ClinicalTrials.gov Identifier: NCT02479126
Recruitment Status : Active, not recruiting
First Posted : June 24, 2015
Last Update Posted : May 3, 2019
Sponsor:
Collaborators:
Durham VA Medical Center
Boehringer Ingelheim
Information provided by (Responsible Party):
Robert Tighe, Durham VA Medical Center

Brief Summary:
The primary objective of this research project is to describe the characteristics, diagnosis, management, and outcomes of patients with Interstitial Lung Disease (ILD) who received care at the Veteran's Administration Veterans Integrated Service Network (VISN) 6 Mid-Atlantic Health Care Network (VISN6) (includes North Carolina, Virginia and West Virginia) for up to 5 years.

Condition or disease
Interstitial Lung Disease

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Interstitial Lung Diseases in the Veterans Administration Health System - A Retrospective Description of Patient Characteristics, Management, and Outcomes
Study Start Date : July 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : June 2020


Group/Cohort
Interstitial Lung Disease
Patients will be identified from a specified 5 year period based on an International Classification of Diseases-9 (ICD-9) code diagnosis of Interstitial Lung disease (515) or Idiopathic Pulmonary Fibrosis (516.3). The patients will be obtained from the records of the Veterans Integrated Service Network (VISN) 6: VA Mid-Atlantic Health Care Network.



Primary Outcome Measures :
  1. Prevalence of Interstitial Lung Disease in the VISN6 Veterans Administration Patient Population [ Time Frame: up to 5 years ]
  2. Prevalence of Idiopathic Pulmonary Fibrosis in the VISN6 Veterans Administration Patient Population [ Time Frame: up to 5 years ]

Secondary Outcome Measures :
  1. Accuracy of ICD-9 Codes for diagnosis of Interstitial Lung Disease [ Time Frame: up to 5 years ]
    Will compare the reported ICD-9 code diagnosis with the diagnosis made after chart review and re-interpretation of the lung imaging and pathology

  2. Frequency of ICD-9 code diagnosis of Interstitial Lung Disease and clinic consultation with a pulmonary provider [ Time Frame: up to 5 years ]
  3. Prevalence of Co-morbid Diabetes Mellitus with Interstitial Lung Disease [ Time Frame: up to five years ]
    Compare the prevalence of diabetes with interstitial lung disease as compared to the prevalence of diabetes in the general VA population



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adults with encounters at any VISN6 healthcare facility during specified time period
Criteria

Inclusion Criteria:

  • Interstitial Lung Disease (ILD) ICD-9 code diagnosis 515.0 or 516.3

Exclusion Criteria:

  • Inadequate documentation of patient receiving care for ILD in the health records

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479126


Locations
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United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Robert Tighe
Durham VA Medical Center
Boehringer Ingelheim
Investigators
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Principal Investigator: Robert M Tighe, MD Duke University Department of Medicine and Durham VA Medical Center

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Responsible Party: Robert Tighe, Staff Physician, Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT02479126     History of Changes
Other Study ID Numbers: 01882
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

Keywords provided by Robert Tighe, Durham VA Medical Center:
Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Electronic Health Records
Computed Tomography
Mortality
Hospitalization
Acute care visits
Anti-inflammatory drug therapies

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases