Point-of-care Ultrasound in Finland
Primary Purpose
Deep Vein Thrombosis, Abdominal Aortic Aneurism, Pneumothorax
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Point-of-care ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Deep Vein Thrombosis focused on measuring Focus assesment with sonography for trauma, POCUS, LOS, Point-of-care ultrasound, length of stay, cost-minimization, primary health care, Ultrasound, Emergency department
Eligibility Criteria
Inclusion Criteria:
- Emergency department patient
- A suspected medical condition, that can be confirmed or excluded by basic POCUS exam, including: free fluid in pleura, pericardium or intraperitoneal space, abdominal aorta aneurysm, gallbladder stones, urine retention, deep venous thrombosis in lower limb, pneumothorax, early pregnancy with non-specified location (confirming intrauterine pregnancy), hydronephrosis.
- Emergency medicine specialist or resident decides to perform a POCUS exam
Exclusion Criteria:
- age under 18
- not able to give informed consent in Finnish
Sites / Locations
- Central Finland central hospital
- Kuopio university hospital
- Saarikka Primary Care Public Utility
- Tampere university hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
No Intervention
Active Comparator
No Intervention
Arm Label
POCUS group
Radiologist group
DVT POCUS group
DVT traditional group
Arm Description
Point-of-care ultrasound
Traditional diagnostic way
DVT group after POCUS education
DVT group traditional diagnostic way before educational intervention
Outcomes
Primary Outcome Measures
Length of stay in emergency department
time between registration in emergency department and "finished from doctor" sign.
Secondary Outcome Measures
Need for follow-up radiologist performed imaging
If radiologist performed ultrasound exam is required, is it performed the same day, during same hospital day or later by appointment. Does the POCUS examination lead to other imaging modality while skipping radiologist performed ultrasound exam.
Accuracy of POCUS exam findings
POCUS findings are compared to any follow-up imaging by radiologist, surgery results or autopsy results when possible
Full Information
NCT ID
NCT03327688
First Posted
October 23, 2017
Last Updated
September 3, 2021
Sponsor
Ossi Hannula
Collaborators
University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT03327688
Brief Title
Point-of-care Ultrasound in Finland
Official Title
Point-of-care Ultrasound in Finland
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ossi Hannula
Collaborators
University of Eastern Finland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study has two aims.
Deep venous thrombosis (DVT) is a common suspected medical condition. If it cannot be excluded clinically and using D-dimer, ultrasound examination is required. An option for traditional radiologist-performed ultrasound is a 2-point compression ultrasound (2-CUS). The safety of this technique is proven. However there does not exist any data on costs comparing traditional and 2-CUS pathways in primary health care. This study will evaluate the total cost of both pathways by conducting a cost-minimization analysis. It will also study the effect of a simple ultrasound education on the referrals to hospital due to suspected DVT.
Hypothesis 1: Short education in ultrasound will reduce significantly referrals to hospital and save resources.
Length of stay (LOS) in emergency department (ED) is related to increased mortality, morbidity, prolonged hospital stay and probably patient satisfaction. LOS of patients with a point-of-care ultrasound (POCUS) performed by an emergency physician (EP) will be compared to those that have a radiology performed ultrasound examination. Further examination and accuracy of POCUS will be noted.
Hypothesis 2: POCUS can shorten LOS significantly in selected clinical conditions
Detailed Description
This study has two aims.
Deep venous thrombosis is a common suspected medical condition. If it cannot be excluded clinically and using D-dimer, ultrasound examination is required. An option for traditional radiologist-performed ultrasound is a 2-point compression ultrasound (2-CUS). The safety of this technique is proven. However there does not exist any data on costs comparing traditional and 2-CUS pathways in primary health care. This study will evaluate the total cost of both pathways by conducting a cost-minimization analysis. It will also study the effect of a simple ultrasound education on the referrals to hospital due to suspected DVT. T
he study is performed in Saarikka Primary Care Public Utility, Saarijärvi, Finland. There are 15 general practitioners (GP) working. During year 2014, 2 of them were performing 2-CUS. 9 of the other GPs were trained during years 2015-2016 to perform a 2-CUS and hence 11 of 15 GPs are able to do 2-CUS in 2017.
This is a register study. Referrals to hospital in 2014 (pre-training) and 2017 (post-training) are examined and the difference is assumed to be because of training and new pathway. Based on population the expected number of referrals due to a suspected DVT should be approximately 100 annually and the expected number after intervention is 30. According to power analysis a reduction from 100 to 76 is statistically significant (p<0.05).
Hypothesis 1: Short education in ultrasound will reduce significantly referrals to hospital and save resources.
Length of stay (LOS) in emergency department (ED) is related to increased mortality, morbidity, prolonged hospital stay and probably patient satisfaction. LOS of patients with a point-of-care ultrasound (POCUS) performed by an emergency physician (EP) will be compared to those that have a radiology performed ultrasound examination.
This part started in Central Finland Central Hospital and Kuopio University Hospital 10/2017. Tampere university hospital will start at 5/2018.
An average LOS in Central Finland Central hospital ED is approximately 150 minutes. In a randomly selected monday in January, 2017, the average time from a referral to radiologist to a finished radiologist statement was 86 minutes. The times in Kuopio university hospital are much longer.
When an EP decides to perform a POCUS exam, they will recruit the patient in the study and fill a simple structured form. It is up to the EP treating the patient to decide if the patients needs POCUS. No additional examination because of this study is made on the patient.
The detailed time stamps for the patient to register in the ED, first doctor visit and finished from the doctor are retrieved from the files. In a follow-up of 6 months it is noted if the patient had a further examination by radiologist and if it was an ultrasound, CT, or some other examination. The results from POCUS will be compared to the radiologist examination, surgery or autopsy results where available and appropriate.
The control group is found from picture archive system (PACS) system with going through ultrasound examinations on the same days as POCUS examinations are made, with a referral question that a POCUS could answer, and referring unit being emergency department, and the same time points will be recorded.
There exists plenty of research on a focused ultrasound examination performed mostly by emergency physicians. In certain clinical questions such as abdominal aorta aneurysm or gallbladder stones, the accuracy of POCUS is excellent.
There also exists some research on POCUS effect on LOS compared to a standard ultrasound examination performed mostly by a radiologist. The reduction in LOS has been huge.
There is no data on regarding the Finnish health care system in this field. Also this study aims to evaluate multiple POCUS indications in a single real life setting which is not published before.
Hypothesis 2: POCUS can shorten LOS significantly in selected clinical conditions
Quality assurance plan: non-existent Data checks: non-existent Source data verification: EP filling the research form fills in only the finding in POCUS. It cannot reliably be verified in any way. All other data comes from medical records.
Data dictionary: Non-existent for now Standard operation procedures: Non-existent
Sample size assesment:
Part 1: a whole year prior and after intervention is evaluated. According to power analysis, change from 100 to 76 would be statistically significant. A reduction of 100 to 30 is expected.
Part 2: According to expected LOS reduction of at least 86 minutes, the study should need only approximately 10 patients + control group to show statistical significance. However a group of 400 patients will be recruited. The purpose of this is to be able to perform quality sub-group analysis based on indication of POCUS but also the experience level of EP performing the POCUS examination.
Plan for missing data: The study form in part 2 is the only reliable source for the POCUS results and if this is missing, the patient must be excluded. All other data is derived from the medical files statistics and should reliable.
Statistical analysis: A cost-minimization analysis will be performed in part 1. Other statistical analysis methods will be decided later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Abdominal Aortic Aneurism, Pneumothorax, Gallbladder Diseases, Hydronephrosis, Pregnancy, Ectopic, Ascites, Pleural Effusion, Pericardial Effusion
Keywords
Focus assesment with sonography for trauma, POCUS, LOS, Point-of-care ultrasound, length of stay, cost-minimization, primary health care, Ultrasound, Emergency department
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Part 1: All referrals to hospital due to a suspected DVT before intervention in year 2014, vs all referrals due to a suspected DVT after intervention in year 2017.
Part 2: POCUS group vs radiologist group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
POCUS group
Arm Type
Active Comparator
Arm Description
Point-of-care ultrasound
Arm Title
Radiologist group
Arm Type
No Intervention
Arm Description
Traditional diagnostic way
Arm Title
DVT POCUS group
Arm Type
Active Comparator
Arm Description
DVT group after POCUS education
Arm Title
DVT traditional group
Arm Type
No Intervention
Arm Description
DVT group traditional diagnostic way before educational intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
Point-of-care ultrasound
Intervention Description
Point-of-care ultrasound performed by an emergency physician
Primary Outcome Measure Information:
Title
Length of stay in emergency department
Description
time between registration in emergency department and "finished from doctor" sign.
Time Frame
Duration of a single emergency department visit. Up to 48 hours.
Secondary Outcome Measure Information:
Title
Need for follow-up radiologist performed imaging
Description
If radiologist performed ultrasound exam is required, is it performed the same day, during same hospital day or later by appointment. Does the POCUS examination lead to other imaging modality while skipping radiologist performed ultrasound exam.
Time Frame
6 months
Title
Accuracy of POCUS exam findings
Description
POCUS findings are compared to any follow-up imaging by radiologist, surgery results or autopsy results when possible
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Emergency department patient
A suspected medical condition, that can be confirmed or excluded by basic POCUS exam, including: free fluid in pleura, pericardium or intraperitoneal space, abdominal aorta aneurysm, gallbladder stones, urine retention, deep venous thrombosis in lower limb, pneumothorax, early pregnancy with non-specified location (confirming intrauterine pregnancy), hydronephrosis.
Emergency medicine specialist or resident decides to perform a POCUS exam
Exclusion Criteria:
age under 18
not able to give informed consent in Finnish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harri Hyppölä, docent
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Finland central hospital
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Kuopio university hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Saarikka Primary Care Public Utility
City
Saarijärvi
ZIP/Postal Code
43100
Country
Finland
Facility Name
Tampere university hospital
City
Tampere
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19007346
Citation
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Results Reference
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21401784
Citation
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Results Reference
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23406071
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
28168226
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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Point-of-care Ultrasound in Finland
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