Interstitial Lung Diseases in the Veterans Administration

July 25, 2022 updated by: Robert Tighe

Interstitial Lung Diseases in the Veterans Administration Health System - A Retrospective Description of Patient Characteristics, Management, and Outcomes

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.

Study Overview

Status

Active, not recruiting

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adults with encounters at any VISN6 healthcare facility during specified time period

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of Interstitial Lung Disease in the VISN6 Veterans Administration Patient Population
Time Frame: up to 5 years
up to 5 years
Prevalence of Idiopathic Pulmonary Fibrosis in the VISN6 Veterans Administration Patient Population
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 5 years
Frequency of ICD-9 code diagnosis of Interstitial Lung Disease and clinic consultation with a pulmonary provider
Time Frame: up to 5 years
up to 5 years
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
up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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