How Point-of-Care Ultrasound Affects the Diagnostic Process in General Practice.
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|ClinicalTrials.gov Identifier: NCT03375333|
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : July 5, 2019
This study explores how Point of Care Ultrasound (POC-US) is used in general practice in Denmark and how it affects the diagnostic process and treatment of patients.
Twenty general practitioners (GPs) will register information each time they use POC-US during a one month period. The information will include indications and frequencies of the performed POC-US examinations, change in tentative diagnosis, plan, and treatment before and after the use of POC-US in relation to confidence in the tentative diagnosis, findings and quality of the POC-US examination.
This is an observational study without any intervention.
|Condition or disease|
|Ultrasound Diagnostics General Practice|
|Study Type :||Observational|
|Actual Enrollment :||579 participants|
|Official Title:||How Point-of-Care Ultrasound Affects the Diagnostic Process in General Practice. A Prospective Follow-up Study.|
|Actual Study Start Date :||January 15, 2018|
|Actual Primary Completion Date :||July 1, 2019|
|Actual Study Completion Date :||July 1, 2019|
20 general practitioners, who use ultrasound in the examination of patients.
- How general practitioners use POC-US in their daily practice: [ Time Frame: 2018 ]
The GP's indication for using POC-US will be described through the frequencies of the GP's intention to rule-in/ rule-out or explore when using POC-US and through frequencies of the tentative diagnoses that entail the use of POC-US.
POC-US frequency is calculated as the number of consultations with POC-US (numerator) relative to all GP face-to-face consultations (denominator) during the study period. The frequency of each POC-US examination (numerator) will be compared to all types of POC-US scans (denominator).
The GPs will measure the time used for the POC-US examination. By the before and after registration of the organs intended to scan and the organ actually scanned, the extent of modification of POC-US to include e.g. opportunistic screening, can be estimated.
The findings in POC-US are measured through the categorical variables: Certain positive findings, uncertain positive findings, certain negative findings, uncertain negative findings, and incidental findings.
- How POC-US influences the diagnostic process [ Time Frame: 2018 ]
The GPs are asked to declare the tentative diagnoses as one main tentative diagnosis and other possible diagnoses before the use of POC-US. After the use of POC-US the GPs will be shown their "Before-US" tentative diagnoses and asked if these diagnoses have changed. If the diagnoses have changed, they will be asked to specify this.
The tentative diagnoses are registered as ICPC-2 codes in the questionnaire. The GPs are asked to register any change in their confidence in the tentative diagnoses after the use of POC-US by choosing one of the following variables on an ordinal scale: Increased confidence, more confident, unchanged confidence, less confident, reduced confidence.
To test the reliability of the GPs' declaration of confidence, we will examine if an increased confidence is correlated to specific organs scanned (Q2.2), a reduction in the total number of diagnoses (Q1.3, Q1.4, Q2.6 and Q2.7), or a change from symptom diagnosis to disease diagnosis.
- How POC-US affects the treatment of the patients: [ Time Frame: 2018 ]
The GPs register their plan for the patient by choosing one or more of the following categorical variables before using POC-US: Acute admission to hospital, subacute referral to hospital, normal referral to hospital, subacute referral to specialist, normal referral to specialist, referral for radiology, other referral e.g. to physiotherapist, follow-up in the clinic, no plan for follow-up, other.
After using POC-US the GP is shown the "before POC-US plan for the patient" and asked if this plan has changed. If the plan has changed, the GP is asked to specify.
The GPs register their initiated treatment before POC-US by choosing one or more of the following categorical variables: Referral for treatment in the secondary sector, medication, other treatment, no treatment, other. After using POC-US the GP is shown the "before POC-US planned treatment for the patient" and asked if this planned treatment has changed. If the planned treatment has changed, the GP is asked to specify.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375333
|Research unit for general practice in Aalborg,department of clinical medicine Aalborg university|
|Study Chair:||Martin Bach Jensen, Professor, GP, PhD||Aalborg University|