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Patient Experiences of Use of Point-of-Care Ultrasound in General Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416608
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Camilla Aakjær Andersen, Aalborg University

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.


Condition or disease
Ultrasound General Practice

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 579 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Patient Experiences of Use of Point-of-Care Ultrasound in General Practice: A Questionnaire Study
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. Information [ Time Frame: assessed immediately after the ultrasound examination ]

    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?


  2. Influence on the consultation [ Time Frame: assessed immediately after the ultrasound examination ]

    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?


  3. Diagnostic reassurance [ Time Frame: assessed immediately after the ultrasound examination ]

    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?


  4. Patient satisfaction [ Time Frame: assessed immediately after the ultrasound examination ]

    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?



Secondary Outcome Measures :
  1. Associations between GP confidence in the diagnosis and patients sense of diagnostic reassurance [ Time Frame: assessed immediately after the ultrasound examination ]
    Association between GPs declared confidence in the tentative diagnosis after using ultrasound in the consultation (data from the original cohort expressed on a scale from increased confidence to decreased confidence) and patients' answers to the question "Has your confidence in the GPs diagnosis changed after the ultrasound examination?" expressed on a scale from decreased to increased confidence.

  2. Associations between GP confidence in the diagnosis and patients experience of improved care [ Time Frame: assessed immediately after the ultrasound examination ]
    Association between GPs declared confidence in the tentative diagnosis after using ultrasound in the consultation (expressed in the original cohort on a scale from increased confidence to decreased confidence) and patients' answers to the question "Do you feel more at ease after the ultrasound examination?" expressed on a scale from less at ease to more at ease.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

Inclusion criteria:

- All patients, who the GP intends to examine with POC-US.

Exclusions criteria:

  • Patient not willing or able to give informed consent
  • Patients previously included in the study

Information from the National Library of Medicine

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): NCT03416608


Locations
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Denmark
Research unit for general practice in Aalborg,department of clinical medicine Aalborg university
Aalborg, Denmark, 9220
Sponsors and Collaborators
Aalborg University
Investigators
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Study Chair: Martin Bach Jensen, Professor, GP, PhD Aalborg University
  Study Documents (Full-Text)

Documents provided by Camilla Aakjær Andersen, Aalborg University:
Study Protocol  [PDF] January 29, 2018

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Responsible Party: Camilla Aakjær Andersen, Principal Investigator, Aalborg University
ClinicalTrials.gov Identifier: NCT03416608    
Other Study ID Numbers: GULD-patient questionnaire
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Camilla Aakjær Andersen, Aalborg University:
ultrasound
patient experience
diagnostic test
general practice
family medicine