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How Point-of-Care Ultrasound Affects the Diagnostic Process 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: NCT03375333
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Camilla Aakjær Andersen, Aalborg University

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.


Condition or disease
Ultrasound Diagnostics General Practice

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Study Type : Observational
Actual Enrollment : 579 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Point-of-Care Ultrasound Affects the Diagnostic Process in General Practice. A Prospective Follow-up Study.
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Group/Cohort
20GPs
20 general practitioners, who use ultrasound in the examination of patients.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. How POC-US influences the diagnostic process [ Time Frame: 2018 ]

    The GPs are asked to declare the tentative diagnoses as one main tentative diagnosis and other possible diagnoses before the use of POC-US. After the use of POC-US the GPs will be shown their "Before-US" tentative diagnoses and asked if these diagnoses have changed. If the diagnoses have changed, they will be asked to specify this.

    The tentative diagnoses are registered as ICPC-2 codes in the questionnaire. The GPs are asked to register any change in their confidence in the tentative diagnoses after the use of POC-US by choosing one of the following variables on an ordinal scale: Increased confidence, more confident, unchanged confidence, less confident, reduced confidence.

    To test the reliability of the GPs' declaration of confidence, we will examine if an increased confidence is correlated to specific organs scanned (Q2.2), a reduction in the total number of diagnoses (Q1.3, Q1.4, Q2.6 and Q2.7), or a change from symptom diagnosis to disease diagnosis.


  2. How POC-US affects the treatment of the patients: [ Time Frame: 2018 ]

    The GPs register their plan for the patient by choosing one or more of the following categorical variables before using POC-US: Acute admission to hospital, subacute referral to hospital, normal referral to hospital, subacute referral to specialist, normal referral to specialist, referral for radiology, other referral e.g. to physiotherapist, follow-up in the clinic, no plan for follow-up, other.

    After using POC-US the GP is shown the "before POC-US plan for the patient" and asked if this plan has changed. If the plan has changed, the GP is asked to specify.

    The GPs register their initiated treatment before POC-US by choosing one or more of the following categorical variables: Referral for treatment in the secondary sector, medication, other treatment, no treatment, other. After using POC-US the GP is shown the "before POC-US planned treatment for the patient" and asked if this planned treatment has changed. If the planned treatment has changed, the GP is asked to specify.




Information from the National Library of Medicine

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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 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.
Criteria

Inclusion Criteria (general practitioners):

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

Exclusion Criteria (general practitioners):

  1. Ultrasound device more than 10 years old
  2. 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.
  3. If less than five patients have been enrolled.

Inclusion/Exclusion criteria (patients):

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.


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): NCT03375333


Locations
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Denmark
Research unit for general practice in Aalborg,department of clinical medicine Aalborg university
Aalborg, Denmark
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] December 4, 2017
Statistical Analysis Plan  [PDF] February 12, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Camilla Aakjær Andersen, MD, Aalborg University
ClinicalTrials.gov Identifier: NCT03375333    
Other Study ID Numbers: RUGPAalborg GULD projektet
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
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
diagnostics
general practice
family medicine