NCT03416608

Brief Summary

This study in part of a larger cohort study (clinical trials ID number: NCT03375333) that examine the use of ultrasound in general practice. In the present study patient experiences, with use of ultrasound in the consultation at the general practitioners office, will be explored through a questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
579

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2018

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

January 10, 2018

Last Update Submit

December 11, 2018

Conditions

Keywords

ultrasoundpatient experiencediagnostic testgeneral practicefamily medicine

Outcome Measures

Primary Outcomes (4)

  • Information

    This domain will be explored through the following questions: Were you informed about the purpose of the ultrasound examination? Were you informed about the difference between a specialist ultrasound and a GP ultrasound? Were you informed about the result of the ultrasound examination?

    assessed immediately after the ultrasound examination

  • Influence on the consultation

    This domain will be explored through the following questions: Did you think the ultrasound examination was a natural part of the consultation? Did you think the ultrasound examination was disruptive in the consultation? Did the ultrasound examination influence the relationship between the GP and you? Do you think ultrasound made a difference in the consultation?

    assessed immediately after the ultrasound examination

  • Diagnostic reassurance

    This domain will be explored through the following questions: Do you feel more thoroughly examined after the ultrasound examination? Do you have a better understanding of your health problem after the ultrasound examination? Do you feel more at ease after the ultrasound examination? Has your confidence in the GPs diagnosis changed after the ultrasound examination? Has the ultrasound examination changed your feeling of being taken seriously?

    assessed immediately after the ultrasound examination

  • Patient satisfaction

    This domain will be explored through the following questions: Was your overall experience with ultrasound in the GP's office positive or negative? Would you recommend ultrasound in the GPs office to others? Do you think ultrasound is a service improvement in the GP's office? Do you think ultrasound is a quality improvement in the GP's office?

    assessed immediately after the ultrasound examination

Secondary Outcomes (2)

  • Associations between GP confidence in the diagnosis and patients sense of diagnostic reassurance

    assessed immediately after the ultrasound examination

  • Associations between GP confidence in the diagnosis and patients experience of improved care

    assessed immediately after the ultrasound examination

Eligibility Criteria

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

The study will take place in 20 different general practices in Denmark where the GPs use POC-US. The participating GPs will try to include all patients were they use POC-US in the consultation. Patients must provide written, informed consent before any study procedures occur (see Appendix 1 for sample Informed Consent Form). Only patients assigned to the GPs practice can participate in the study.

You may qualify if:

  • \- All patients, who the GP intends to examine with POC-US.
  • Patient not willing or able to give informed consent
  • Patients previously included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aalborg, 9220, Denmark

Location

Related Publications (1)

  • Andersen CA, Brodersen J, Rudbaek TR, Jensen MB. Patients' experiences of the use of point-of-care ultrasound in general practice - a cross-sectional study. BMC Fam Pract. 2021 Jun 18;22(1):116. doi: 10.1186/s12875-021-01459-z.

Study Officials

  • Martin Bach Jensen, Professor, GP, PhD

    Aalborg University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 31, 2018

Study Start

January 15, 2018

Primary Completion

September 1, 2018

Study Completion

September 2, 2018

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations