- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01825538
Assessment of Pulmonary Specialty Physicians' Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43210
- The Ohio State University Wexner Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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COPD, pulmonary fibrosis
observational study, no interventions to be administered
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Record the presence or absence of Advanced Care Planning (ACP) discussions with patients with advanced lung disease
Zeitfenster: Last two years
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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.
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Last two years
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jennifer W McCallister, M.D, The Ohio State University Wexner Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2012H0435
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