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OpenTrials
Completed

NCT Number: NCT01825538

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

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.

Completed

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Key information

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Treatment and study plan

Primary outcomes

  1. Record the presence or absence of Advanced Care Planning (ACP) discussions with patients with advanced lung disease

    Time frame: Last two years

    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.

Sponsors and collaborators

Lead sponsor

Jennifer McCallister MD

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 5, 2013
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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