- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01825538
Assessment of Pulmonary Specialty Physicians' Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University Wexner Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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COPD, pulmonary fibrosis
observational study, no interventions to be administered
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Record the presence or absence of Advanced Care Planning (ACP) discussions with patients with advanced lung disease
Tidsramme: 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.
|
Last two years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jennifer W McCallister, M.D, The Ohio State University Wexner Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012H0435
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