NCT04396925

Brief Summary

The scope of this study is to explore how general practitioners (GPs) use Point-of-Care Ultrasonography (POCUS) in Norway. Thirty GPs will register information each time they use POCUS during a three-month period. Acquired information include the purpose of the scan, which organ is scanned, frequencies of POCUS and changes in diagnosis, plan, and treatment after the scan. This is a strict observational study without any intervention.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
2.5 years until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

May 15, 2020

Last Update Submit

May 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • How general practitioners use POCUS in their daily practice

    The GPs' indications for the use of point-of-care ultrasound (POCUS) will be described through the number and type of scans performed, and through frequencies of the tentative diagnoses that warrant the use of POCUS. The frequency of each POCUS examination (numerator) will be compared to all performed scans (denominator). The GPs will register the time used for the POCUS examination. By the before and after registration of the organs intended to scan and the organ actually scanned, the extent of modification of tentative diagnosis, plan for further examination and/or treatment.

    2024

Secondary Outcomes (2)

  • How GPs evaluate their confidence

    2024

  • Characteristics of the physician that influence the effect of POCUS

    2024

Interventions

GPs using POCUS and how it affects clinical judgement

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General practitioners who use point-of-care ultrasonography as a part of clinical practice. Out-of-hours scanning excluded

You may qualify if:

  • General practitioners who use point-of-care ultrasound in day time general practice

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Norway

Location

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Mette Brekke, Professor

    University of Oslo, Department of General Practice

    STUDY CHAIR
  • Hans-Christian Myklestul, M.D.

    University of Oslo, Department of General Practice

    PRINCIPAL INVESTIGATOR
  • Trygve Skonnord, PhD

    University of Oslo, Department of General Practice

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Mette Brekke

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 21, 2020

Study Start

December 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

The data registered are available for the cooperating researchers at the university in Aalborg Denmark. The purpose of further analyses is to compare the external validity of the questionnaire.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
2025
Access Criteria
The data are only available for cooperating researchers in Aalborg, Denmark including Martin Bach Jensen and Camilla Aakjaer Andersen

Locations