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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825538
• Other study ID #: 2012H0435
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: July 24, 2014
• Start date: February 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jennifer McCallister MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Record the presence or absence of Advanced Care Planning (ACP) discussions with patients with advanced lung disease	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.	Last two years	No