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Clinical Trials/NCT03375333
NCT03375333CompletedNot Applicable

How Point-of-Care Ultrasound Affects the Diagnostic Process in General Practice. A Prospective Follow-up Study.

Aalborg University1 site in 1 country579 target enrollmentStarted: January 15, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
579
Locations
1
Primary Endpoint
How general practitioners use POC-US in their daily practice:

Study Overview

Brief Summary

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.

Detailed Description

This is a prospective, observational study aiming to describe: How general practitioners use POC-US in their daily practice, how POC-US influences the diagnostic process, and how POC-US affects the treatment of the patients.

The Use of POC-US will be explored through indication, frequency, time consumption, modification, and findings in order to describe:

  • Which organs the GPs scan, when using POC-US?
  • Which tentative diagnoses entail the use of POC-US?
  • If GPs intend to rule-in/rule-out or explore, when using POC-US?
  • How often the GPs use POC-US?
  • How often are the GPs able to produce POC-US pictures of relevant structures?
  • How much time POC-US adds to the consultation?
  • How often a difference in what the GP intends to scan and what POC-US is actually used for occurs (modification of the performed POC-US)?
  • How often POC-US leads to a specific finding?

The influences of the diagnostic process will be explored through change in the tentative diagnosis and change in the GP's confidence in the tentative diagnosis. The aim is to describe:

  • If POC-US changes the patient's tentative diagnosis
  • If POC-US increases the GP's confidence in the tentative diagnosis
  • The relationship between the GP's expression of confidence and change in the number of tentative diagnoses
  • The relationship between change from symptom diagnoses to disease diagnoses and the GP's expression of confidence in the tentative diagnosis
  • The relationship between specific organs scanned and the GP's expression of confidence in the tentative diagnosis

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • How POC-US influences the diagnostic process(2018)
  • How POC-US affects the treatment of the patients:(2018)

Investigators

Sponsor
Aalborg University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Camilla Aakjær Andersen

MD

Aalborg University

Study Sites (1)

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