Assessment of Pulmonary Specialty Physicians' Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer McCallister MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01825538
First received: March 21, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

To understand current practices of pulmonary physicians in relation to Advanced Care Planning (ACP) in order to develop future disease-specific tools that will improve patient-physician communication about ACP.


Condition
Chronic Obstructive Pulmonary Disease
Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Pulmonary Specialty Physicians' Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Record the presence or absence of Advanced Care Planning (ACP) discussions with patients with advanced lung disease [ Time Frame: Last two years ] [ Designated as safety issue: No ]
    This is a descriptive study which will retrospectively review whether Advanced Care Planning discussions have been documented in the medical records of patients with chronic obstructive pulmonary disease or pulmonary fibrosis. Using pre-existing data, we will determine if Advanced Care Planning has been discussed with these patients and record this information.


Enrollment: 93
Study Start Date: February 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD, pulmonary fibrosis
observational study, no interventions to be administered

Detailed Description:

The study will be a retrospective, observational study and analysis of charts of patients with Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis treated as outpatients at the Ohio State University Wexner Medical Center Lung Center. Using pre-existing data, we will determine if advanced care planning has been discussed with these patients and record this information. For all patients, we will gather data about specific demographic and clinical characteristics that may have contributed to the presence or absence of these discussions. The study is descriptive in nature and is not powered to detect a difference between the two groups. Instead, we aim to describe the characteristics most frequently associated with advanced care planning discussion in these two particular groups.

Potential subjects will be identified with assistance from the Information Warehouse. After identification, data will be abstracted from pre-existing data in the electronic medical record and collected in a coded fashion for each subject. Each subject will be assigned an anonymous subject identification number and all links to identifying information will be destroyed prior to analysis. All study data will be stored on a secure password protected data base to which only study personnel will have access.

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with COPD or pulmonary fibrosis

Criteria

Inclusion Criteria:

  1. Patients who are between 18 and 88 years of age who have been diagnosed with a physician diagnosis of COPD based on at least one of the following:

    • clinical history - a documented history of COPD, emphysema, or chronic bronchitis.
    • pulmonary function results - defined as an forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) less than 0.7
  2. Patients who are between 18 and 88 years of age and have been diagnosed with pulmonary fibrosis based on the following:

    • Subpleural, basal predominance of parenchymal abnormality on high resolution computed tomography (HRCT)
    • Reticular abnormality on HRCT
    • Honeycombing without traction bronchiectasis on HRCT
    • Absence of features that are inconsistent with usual interstitial pneumonia (UIP) pattern OR
    • UIP based on surgical lung biopsy

Exclusion Criteria:

  • Age < 18 years or > 88 years
  • Prisoners
  • Pregnant patients
  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: NCT01825538

Locations
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Jennifer McCallister MD
Investigators
Principal Investigator: Jennifer W McCallister, M.D The Ohio State University Wexner Medical Center
  More Information

No publications provided

Responsible Party: Jennifer McCallister MD, Associate Professor-Clinical, The Ohio State University
ClinicalTrials.gov Identifier: NCT01825538     History of Changes
Other Study ID Numbers: 2012H0435
Study First Received: March 21, 2013
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Chronic obstructive pulmonary disease
Pulmonary fibrosis
Advanced care planning

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014