NCT05696821

Brief Summary

In a stepped-wedge cluster randomized trial, the effects of an educational intervention will be determined by estimating the uptake of point-of-care ultrasound by general practitioners (outcome P1), change in referral from primary care to secondary care (outcome P2), change in number of consultations delivered in primary care (outcome S1), GPs job satisfaction, level of stress, and burn-out (outcomes S2-4), as well as the number of point-of-care ultrasound related adverse events (outcome S5), a health economic evaluation (outcome S6) and the patient experience of point-of-care ultrasound (outcome S7). Two-hundred general practitioners (GPs) will participate in the study. Participants will be randomized to participate in clusters with a training facility close to their clinic. All participants will be offered the educational intervention. Ten clusters will receive the intervention at different timepoints.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

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

September 30, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

September 30, 2022

Last Update Submit

March 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • The uptake of the intervention in primary care

    The effect on the uptake of POCUS following an educational intervention for general practice clinics will be determined by comparing the number of registered reimbursement codes before the intervention to the number of reimbursement codes registered after the intervention.

    months 3- 21

  • Change in number of referrals for secondary care

    The effects of an educational intervention for general practice clinics on the number of referrals send to secondary care specialists, will be determined by comparing the number of registered referrels (number of referrals to hospital or specialist clinics/number of consultations) before the intervention to the number of registered referrals after the intervention.

    months 1- 21

Secondary Outcomes (7)

  • Change in number of consultations in primary care

    months 1- 21

  • Change in GPs' perceived stress

    Estimated in each cluster 1 months before the intervention and six months after the intervention

  • Change in GPs' job satisfaction

    Estimated in each cluster 1 months before the intervention and six months after the intervention

  • Change in GPs' burnout symptoms

    Estimated in each cluster 1 months before the intervention and six months after the intervention

  • Change in healthcare costs

    months 1-21

  • +2 more secondary outcomes

Other Outcomes (3)

  • Change in GPs' job contentment

    Estimated in each cluster 1 months before the intervention and six months after the intervention

  • GPs' experience of POCUS use

    Estimated in each cluster six months after the intervention

  • GPs' experiences of POCUS' influence

    Estimated in each cluster six months after the intervention

Study Arms (10)

Cluster 1

OTHER

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control. Cluster one contributes with 3 months unexposed and 18 months exposed outcomes.

Diagnostic Test: Educational intervention

Cluster 2

OTHER

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control. Cluster one contributes with 4 months unexposed and 17 months exposed outcomes.

Diagnostic Test: Educational intervention

Cluster 3

OTHER

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control. Cluster one contributes with 5 months unexposed and 16 months exposed outcomes.

Diagnostic Test: Educational intervention

Cluster 4

OTHER

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control. Cluster one contributes with 6 months unexposed and 15 months exposed outcomes.

Diagnostic Test: Educational intervention

Cluster 5

OTHER

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control. Cluster one contributes with 8 months unexposed and 13 months exposed outcomes.

Diagnostic Test: Educational intervention

Cluster 6

OTHER

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control. Cluster one contributes with 10 months unexposed and 11 months exposed outcomes.

Diagnostic Test: Educational intervention

Cluster 7

OTHER

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control. Cluster one contributes with 12 months unexposed and 9 months exposed outcomes.

Diagnostic Test: Educational intervention

Cluster 8

OTHER

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control. Cluster one contributes with 13 months unexposed and 8 months exposed outcomes.

Diagnostic Test: Educational intervention

Cluster 9

OTHER

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control. Cluster one contributes with 14 months unexposed and 7 months exposed outcomes.

Diagnostic Test: Educational intervention

Cluster 10

OTHER

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control. Cluster one contributes with 15 months unexposed and 6 months exposed outcomes.

Diagnostic Test: Educational intervention

Interventions

The educational intervention includes a 3-months training program in the use of point-of-care ultrasound tailored to meet the educational needs of general practitioners. The training programs consists of three teaching seminars over a three month time period, a curriculum of 10 POCUS applications, and an online learning platform providing educational support before, during and after the teaching sessions.

Cluster 1Cluster 10Cluster 2Cluster 3Cluster 4Cluster 5Cluster 6Cluster 7Cluster 8Cluster 9

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • GPs who are postgraduate medical doctor with a specialization in general practice
  • GPs who work in office-based Danish general practice
  • GPs who have access to an ultrasound device in the practice during the study period

You may not qualify if:

  • GPs not willing to participate in the data collection or share data for this study
  • No signed informed consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for General Practice at Aalborg University

Aalborg, 9220, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the study the intervention cannot be blinded to the participants, but for statistical assessment, data will be blinded as regard to time of collection and location.
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: stepped-wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, MD, PhD

Study Record Dates

First Submitted

September 30, 2022

First Posted

January 25, 2023

Study Start

January 1, 2023

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations