Interstitial Lung Diseases in the Veterans Administration

Sponsor
Robert Tighe (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT02479126
Collaborator
Durham VA Medical Center (U.S. Fed), Boehringer Ingelheim (Industry)
3,000
1
83
36.1

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Jul 1, 2016
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of Interstitial Lung Disease in the VISN6 Veterans Administration Patient Population [up to 5 years]

    2. Prevalence of Idiopathic Pulmonary Fibrosis in the VISN6 Veterans Administration Patient Population [up to 5 years]

    Secondary Outcome Measures

    1. Accuracy of ICD-9 Codes for diagnosis of Interstitial Lung Disease [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 [up to 5 years]

    3. Prevalence of Co-morbid Diabetes Mellitus with Interstitial Lung Disease [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Durham VA Medical Center Durham North Carolina United States 27705

    Sponsors and Collaborators

    • Robert Tighe
    • Durham VA Medical Center
    • Boehringer Ingelheim

    Investigators

    • Principal Investigator: Robert M Tighe, MD, Duke University Department of Medicine and Durham VA Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Tighe, Staff Physician, Durham VA Medical Center
    ClinicalTrials.gov Identifier:
    NCT02479126
    Other Study ID Numbers:
    • 01882
    First Posted:
    Jun 24, 2015
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022

    Study Results

    No Results Posted as of Jul 26, 2022