Clinical trial NCT01825538: Assessment of Pulmonary Specialty Physicians' Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases
Official title: Assessment of Pulmonary Specialty Physicians' Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Fibrosis
Keywords: Chronic obstructive pulmonary disease
Pulmonary fibrosis
Advanced care planning
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD or pulmonary fibrosis

Brief 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.

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 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

Primary outcomes:
measure: Record the presence or absence of Advanced Care Planning (ACP) discussions with patients with advanced lung disease
timeFrame: Last two years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jennifer W McCallister, M.D
role: PRINCIPAL_INVESTIGATOR
References: