Clinical trial NCT03327688: Point-of-care Ultrasound in Finland
Official title: Point-of-care Ultrasound in Finland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2017-10-31
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: DIAGNOSTIC

Brief summary: This study has two aims.

1. 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.
2. 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.

1. 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.
2. 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.

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

Primary outcomes:
measure: Length of stay in emergency department
timeFrame: Duration of a single emergency department visit. Up to 48 hours.
Secondary outcomes:
measure: Need for follow-up radiologist performed imaging
timeFrame: 6 months
measure: Accuracy of POCUS exam findings
timeFrame: 6 months
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland central hospital
city: Kuopio
country: Finland
facility: Kuopio university hospital
city: Saarijärvi
country: Finland
facility: Saarikka Primary Care Public Utility
city: Tampere
country: Finland
facility: Tampere university hospital
Study officials:
affiliation: Kuopio University Hospital
name: Harri Hyppölä, docent
role: PRINCIPAL_INVESTIGATOR
References:
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