The POCUS in Practice Study
PIP
1 other identifier
interventional
200
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
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
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 18, 2025
March 1, 2025
1.9 years
September 30, 2022
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
OTHERParticipants 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.
Cluster 2
OTHERParticipants 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.
Cluster 3
OTHERParticipants 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.
Cluster 4
OTHERParticipants 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.
Cluster 5
OTHERParticipants 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.
Cluster 6
OTHERParticipants 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.
Cluster 7
OTHERParticipants 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.
Cluster 8
OTHERParticipants 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.
Cluster 9
OTHERParticipants 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.
Cluster 10
OTHERParticipants 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.
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.
Eligibility Criteria
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
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
- 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