Point-of-care Ultrasound in Finland

Deep Vein Thrombosis Clinical Trial

Official title:

Point-of-care Ultrasound in Finland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327688
• Other study ID #: KUH507T027
• Status: Completed
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2021
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurism
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Ascites
• Deep Vein Thrombosis
• Gallbladder Diseases
• Hydronephrosis
• Pericardial Effusion
• Pleural Effusion
• Pneumothorax
• Pregnancy, Ectopic
• Thrombosis
• Venous Thrombosis

Intervention

Diagnostic Test:
• Point-of-care ultrasound
Point-of-care ultrasound performed by an emergency physician

Locations

Country	Name	City	State
Finland	Central Finland central hospital	Jyväskylä
Finland	Kuopio university hospital	Kuopio
Finland	Saarikka Primary Care Public Utility	Saarijärvi
Finland	Tampere university hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Ossi Hannula	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

References & Publications (9)

Alrajab S, Youssef AM, Akkus NI, Caldito G. Pleural ultrasonography versus chest radiography for the diagnosis of pneumothorax: review of the literature and meta-analysis. Crit Care. 2013 Sep 23;17(5):R208. doi: 10.1186/cc13016. Review. — View Citation

Bernstein SL, Aronsky D, Duseja R, Epstein S, Handel D, Hwang U, McCarthy M, John McConnell K, Pines JM, Rathlev N, Schafermeyer R, Zwemer F, Schull M, Asplin BR; Society for Academic Emergency Medicine, Emergency Department Crowding Task Force. The effect of emergency department crowding on clinically oriented outcomes. Acad Emerg Med. 2009 Jan;16(1):1-10. doi: 10.1111/j.1553-2712.2008.00295.x. Epub 2008 Nov 8. Review. — View Citation

Birdwell BG, Raskob GE, Whitsett TL, Durica SS, Comp PC, George JN, Tytle TL, McKee PA. The clinical validity of normal compression ultrasonography in outpatients suspected of having deep venous thrombosis. Ann Intern Med. 1998 Jan 1;128(1):1-7. — View Citation

Park YH, Jung RB, Lee YG, Hong CK, Ahn JH, Shin TY, Kim YS, Ha YR. Does the use of bedside ultrasonography reduce emergency department length of stay for patients with renal colic?: a pilot study. Clin Exp Emerg Med. 2016 Dec 30;3(4):197-203. doi: 10.15441/ceem.15.109. eCollection 2016 Dec. — View Citation

Ross M, Brown M, McLaughlin K, Atkinson P, Thompson J, Powelson S, Clark S, Lang E. Emergency physician-performed ultrasound to diagnose cholelithiasis: a systematic review. Acad Emerg Med. 2011 Mar;18(3):227-35. doi: 10.1111/j.1553-2712.2011.01012.x. Review. — View Citation

Rubano E, Mehta N, Caputo W, Paladino L, Sinert R. Systematic review: emergency department bedside ultrasonography for diagnosing suspected abdominal aortic aneurysm. Acad Emerg Med. 2013 Feb;20(2):128-38. doi: 10.1111/acem.12080. Review. — View Citation

Stein JC, Wang R, Adler N, Boscardin J, Jacoby VL, Won G, Goldstein R, Kohn MA. Emergency physician ultrasonography for evaluating patients at risk for ectopic pregnancy: a meta-analysis. Ann Emerg Med. 2010 Dec;56(6):674-83. doi: 10.1016/j.annemergmed.2010.06.563. Epub 2010 Sep 15. — View Citation

Ten Cate-Hoek AJ, Toll DB, Büller HR, Hoes AW, Moons KG, Oudega R, Stoffers HE, van der Velde EF, van Weert HC, Prins MH, Joore MA. Cost-effectiveness of ruling out deep venous thrombosis in primary care versus care as usual. J Thromb Haemost. 2009 Dec;7(12):2042-9. doi: 10.1111/j.1538-7836.2009.03627.x. Epub 2009 Sep 28. — View Citation

Wilson SP, Connolly K, Lahham S, Subeh M, Fischetti C, Chiem A, Aspen A, Anderson C, Fox JC. Point-of-care ultrasound versus radiology department pelvic ultrasound on emergency department length of stay. World J Emerg Med. 2016;7(3):178-82. doi: 10.5847/wjem.j.1920-8642.2016.03.003. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in emergency department	time between registration in emergency department and "finished from doctor" sign.	Duration of a single emergency department visit. Up to 48 hours.
Secondary	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.	6 months
Secondary	Accuracy of POCUS exam findings	POCUS findings are compared to any follow-up imaging by radiologist, surgery results or autopsy results when possible	6 months