The Clinical Impact of POCUS Use in General Practice

NCT05523882 | Completed DMC

• 1 other identifier: ID 242-3
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Being a hybrid type 2 effectiveness-implementation study, this study aims to simultaneous assess the clinical effectiveness of the introduction of point-of-care unltrasound in general practice and to measure the impact of the implementation strategy as co-primary aims.

Conditions

Point-of-care Ultrasound

Keywords

general practice; family medicine; ultrasound; implementation

Outcome Measures

Primary Outcomes (5)

• (E1) how the frequency of use of different POCUS examinations develops in the first year after introducing POCUS use in general practice including the variation over time and between GPs.

  Number of POCUS examinations performed will be collected as 11 specific remuneration codes (corresponding to 11 different POCUS examinations) registred in the medical record system by each participating GP

  From the first teaching seminar to 24 months after the first teaching seminar

• (E2) how the frequency of referrals for secondary care develops in the first year after introducing POCUS use in general practice and including the variation in referrals over time and between GPs.

  Number of referals for secondary care registrered in the medical record system by each participating GP

  From the first teaching seminar to 24 months after the first teaching seminar

• (E3) how the number of consultations delivered in primary care develops in the first year after introducing POCUS use in general practice including the variation over time and between GPs.

  Number of consultations will be collected as remununeration codes registrered in the medical record system by each participating GP

  From the first teaching seminar to 24 months after the first teaching seminar

• (E4) how the GPs' reported effect of POCUS on their clinical decision and patient management in general practice develops in the first year after introducing POCUS use in general practice.

  In a questionnaire, the GPs will be asked to specify the following for each POCUS examination: (1) organs/structures examined with POCUS (drop down menu or free text), (2) whether POCUS use entailed a change in diagnosis (yes/no), (3) whether POCUS use entailed a change in referral (yes/no), (4) whether POCUS use entailed a change in treatment (yes/no), (5) whether POCUS use entailed a change in diagnostic certainty for the GP (yes/no), (6) whether POCUS use was helpful for the GP in terms of making a decision for patient management (5-point Likert scale), (7) whether POCUS use was helpful for the GP in terms of arriving at a diagnosis (5-point Likert scale). GP will assess the questionnaire immediately after performing POCUS during consultations in clinical practice.

  From the first teaching seminar to 12 months after the first teaching seminar

• (E5) the number of unwanted cases associated with the use of POCUS reported by the participating GPs in the first year after introducing POCUS use in general practice.

  For the registration of unwanted cases (outcome E5), we will use a questionnaire giving the GPs the possibility to explain in free text using their own words to explain (1) what was scanned, (2) circumstances surrounding the scan, (3) what happened, and (4) reflections after the scan.

  From the first teaching seminar to 24 months after the first teaching seminar

Other Outcomes (8)

• (I1) Adoption: the proportion of participating GPs that adopt the intervention and start using POCUS in their daily practice during the educational intervention.

  months 1-3

• (I2) Fidelity (adherence): the proportion of participating GPs that complete the educational elements in the intervention (pre-post tests, webinars, assignments, attendance on seminar days, logbook registrations).

  months 1-3

• (I3) Reach (penetration): The proportion of teachers who actively support participants by engaging in the online part of the educational interventions

  months 1-3

Interventions

point-of-care ultrasound DIAGNOSTIC_TEST

All participants will receive the same ultrasound education through attendance of the ultrasound course arranged by PLO-e. The educations intervention consists of three teaching seminars delivered over three months, a curriculum of 10 POCUS applications, an online learning platform providing educational support before, during, and after the teaching sessions (see Figure 2). The online platform includes videos demonstrating the performance of POCUS, suggestions for additional literature, assignments to support the development of skills, self-quizzes to focus attention of learning outcomes and specific actioncards for each of the 10 POCUS applications framing the examinations in the clinical context. In addition, the online platform provides participants access to webinars and communication with other participants and teachers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All GPs participating in two ultrasound courses organized by PLO-e (course number 9018822 and 9017222) are eligible to participate in this study. All patients seen in general practice, that the GPs find relevant to examine with POCUS can be used in the data collection. For this study, we will not collect identifiable personal or health-related data on patients. However, we will receive aggregated data on patients' age and gender. These data are used to describe the patient population but will neither be stored with the other study data nor used in analysis with other data

You may qualify if:

• Postgraduate medical doctor with a specialization in general practice
• Working in office-based Danish general practice
• Access to an ultrasound device in the practice during the study period

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University: lead
• The General Practice Foundation in Denmark (grant number A3495): collaborator
• The Novo Nordisk Foundation (grant number 0061821): collaborator
• The Primary Sector Data Provider Platform (PLSP): collaborator

Study Sites (1)

Camilla Aakjaer Andersen

Aalborg, 9220, Denmark

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, MD, PhD

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: August 31, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)