How Point-of-Care Ultrasound Affects the Diagnostic Process in General Practice.

NCT03375333 | Completed DMC

• 1 other identifier: RUGPAalborg GULD projektet
• Study Type: observational
• Target: 579
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound; Diagnostics; General Practice

Keywords

ultrasound; diagnostics; general practice; family medicine

Outcome Measures

Primary Outcomes (1)

• How general practitioners use POC-US in their daily practice:

  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.

  2018

Secondary Outcomes (2)

• How POC-US influences the diagnostic process

  2018

• How POC-US affects the treatment of the patients:

  2018

Study Arms (1)

20GPs

20 general practitioners, who use ultrasound in the examination of patients.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participating GP practices will be selected purposively aiming at a difference in organisation, geography, and equipment. GPs will be selected to vary in experience both regarding seniority as GPs and experience of using POC-US. Thus we will include partnerships and solo practices, urban and rural practices as well as practices with variable number of probes and type of ultrasound scanner.

You may qualify if:

• Broad use of ultrasound
• Working week of minimum four days
• A minimum of 1400 patients listed
• A minimum of two scanning probes
• Previous participation in formal education in the use of ultrasound
• Minimum six months experience with ultrasound in general practice.
• Estimated use of ultrasound on a daily basis (average)

You may not qualify if:

• Ultrasound device more than 10 years old
• Conflict of interest, e.g. if the GP is part of the research group or if the GP has direct financial interest in selling US devices.
• If less than five patients have been enrolled.
• All patients who consult the participating GP for conditions relevant for a POC-US examination will be offered to participate in the study. Patients are excluded if they do not wish to participate or if they are not able to give an informed consent.

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Research unit for general practice in Aalborg,department of clinical medicine Aalborg university

Aalborg, Denmark

Location

Related Publications (2)

• Andersen CA, Brodersen JB, Mainz J, Thomsen JL, Graumann O, Lokkegaard T, Jensen MB. Does point-of-care ultrasound examination by the general practitioner lead to inappropriate care? A follow-up study. Scand J Prim Health Care. 2025 Sep;43(3):613-625. doi: 10.1080/02813432.2025.2487095. Epub 2025 Apr 10.

  PMID: 40207775 DERIVED

• Aakjaer Andersen C, Brodersen J, Davidsen AS, Graumann O, Jensen MBB. Use and impact of point-of-care ultrasonography in general practice: a prospective observational study. BMJ Open. 2020 Sep 17;10(9):e037664. doi: 10.1136/bmjopen-2020-037664.

  PMID: 32948563 DERIVED

Study Officials

• Martin Bach Jensen, Professor, GP, PhD

  Aalborg University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: January 15, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

DK (1)