Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CT scan before chest physician
Usual diagnostic workup
Sponsored by
About this trial
This is an interventional health services research trial for Lung Cancer focused on measuring Organization, of fast track
Eligibility Criteria
Inclusion Criteria:
- All patients referred to fast track evaluation (lung department, Aarhus university hospital) from primary care.
Exclusion Criteria:
- Not referred from general practice
Sites / Locations
- Aarhus University
- Department of lung medicine, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CT scan before chest physician
Usual diagnostic workup
Arm Description
CT scan before chest physician
Usual diagnostic workup
Outcomes
Primary Outcome Measures
Chest physician time
Time (in minutes) spent by a chest physician pr patient
Secondary Outcome Measures
Satisfaction with new organisation
Measured with a qualitative focus interview with staff a the Department of lung medicine (doctors, nurses and secretary).
Full Information
NCT ID
NCT01779726
First Posted
January 28, 2013
Last Updated
December 2, 2014
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT01779726
Brief Title
Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis
Official Title
Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis. A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease is an important prognostic factor as an advanced stage reduces the opportunity for surgical intervention and other curative treatment. In denmark, as in many other countries, a fast track evaluation for lung cancer has been introduced in 2008.
When the general practitioners refer patients through the fast track, the majority of patients make their first visit to the Department of Pulmonary Medicine. After this visit, further investigation is initiated, which is often a CT scan of the chest and the upper abdomen. We dont know Whether this is the most appropriate organisation.
The aim of this project is to evaluate the way lung cancer patients are examined through the fast track and the impact of chest CT before an evaluation by a chest physician.
Investigators want to randomise all patients referred for the existing fast track to either direct CT scan of chest and upper abdomen or to evaluation by the chest physician, in order to test:
A) Fast track performance measured by number of CT scans and chest physician specialist time per diagnosis, and whether there is a difference between the intervention and the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Organization, of fast track
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
331 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT scan before chest physician
Arm Type
Experimental
Arm Description
CT scan before chest physician
Arm Title
Usual diagnostic workup
Arm Type
Active Comparator
Arm Description
Usual diagnostic workup
Intervention Type
Radiation
Intervention Name(s)
CT scan before chest physician
Intervention Description
Patients referred to department of lung medicine are randomised according to the month of birth. Patients born in even months are CT scan before a consultation with a chest physician
Intervention Type
Radiation
Intervention Name(s)
Usual diagnostic workup
Intervention Description
Patients born in odd months seen in the department of lung medicine by a chest physician and maybe then CT scanned (usual workup practice according to the fast track evaluation)
Primary Outcome Measure Information:
Title
Chest physician time
Description
Time (in minutes) spent by a chest physician pr patient
Time Frame
2013
Secondary Outcome Measure Information:
Title
Satisfaction with new organisation
Description
Measured with a qualitative focus interview with staff a the Department of lung medicine (doctors, nurses and secretary).
Time Frame
2013
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients referred to fast track evaluation (lung department, Aarhus university hospital) from primary care.
Exclusion Criteria:
Not referred from general practice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Vedsted, M.D., Prof.
Organizational Affiliation
The Research Unit for General Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Department of lung medicine, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24355447
Citation
Guldbrandt LM, Fenger-Gron M, Folkersen BH, Rasmussen TR, Vedsted P. Reduced specialist time with direct computed tomography for suspected lung cancer in primary care. Dan Med J. 2013 Dec;60(12):A4738.
Results Reference
derived
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Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis
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