Family MedicineNCT05986110
Analysis of the Results Obtained in the Regular Clinical Practice of a Clinical Ultrasound Classroom For Primary Care Physicians As a Formative Intervention System
A study testing A training intervention on clinical ultrasound in people with Family Medicine and Clinical Ultrasound, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
The objectives of the project are to evaluate the theoretical-practical knowledge acquired and the degree of satisfaction of a methodology based on theoretical-practical training in abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary Health Care, and to evaluate the benefit… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Family Medicine, Clinical Ultrasound, Primary Care
- What is being tested?
- A training intervention on clinical ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To work in selected health centers.
- To have assigned to more than 800 patients.
- Not have previous training in regulated clinical ultrasound.
- Sign a commitment to Attendance at least 80% of the training program sessions.
- Sign the informed consent.
Who cannot join
- Not meeting any of the inclusion criteria.
- Not signing the informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Primary Care Research Unit of Salamanca
Salamanca, 37006
Luis García Ortiz, MD, 0034923231859, lgarciao@usal.es
Fernando Perez Escanilla, MD, fperezes@saludcastillayleon.es
About this study
The objectives of the project are to evaluate the theoretical-practical knowledge acquired and the degree of satisfaction of a methodology based on theoretical-practical training in abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary Health Care, and to evaluate the benefit obtained by patients over 60 years of age included in the program, analyzing the degree of satisfaction, resolution time of the reason for consultation and decrease in the number of referrals to the second level of care, analyzing the differences by gender.
Read the detailed description
The objectives of the project are to evaluate the theoretical-practical knowledge acquired and the degree of satisfaction of a methodology based on theoretical-practical training in abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary Health Care, and to evaluate the benefit obtained by patients over 60 years of age included in the program, analyzing the degree of satisfaction, resolution time of the reason for consultation and decrease in the number of referrals to the second level of care, analyzing the differences by gender.
The expected impact is that the doctors participating in the project learn to perform abdominal and thyroid ultrasound and continue to perform them during the year that their participation in the project lasts, and independently thereafter. In addition, this will allow the reduction of interconsultations to the specialized care and emergencies of their patients whose primary care physicians perform ultrasound scans in their health center.
Its application in clinical practice will be reflected because doctors who perform ultrasound scans in their primary care centers will increase their diagnostic certainty in real consultation time on many occasions, thereby reducing interconsultations at the second level of care, and when they have to refer a patient at this level, they will do so in a more documented manner.
- Conditions
- Family Medicine, Clinical Ultrasound, Primary Care
- Being tested
- A training intervention on clinical ultrasound
- Keywords
- Family medicine, Clinical ultrasound, Primary care, Resolution improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A training intervention on clinical ultrasoundProcedure or surgery
To train 20 primary care family doctors in clinical ultrasound so that they have greater power of resolution and allow them to limit the diagnostic and surgical times on the waiting lists of their patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Procedure: A training intervention on clinical ultrasound |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of knowledge and skills
An initial evaluation of knowledge will be carried out prior to the start of the training intervention, which will consist of 10 multiple choice questions with four possible answers with only 1 correct one (5 theoretical questions on the fundamentals and use of ultrasound, and interpretation of 5 images of pathologies or ultrasound anatomy). For the final evaluation, a new test will be carried out, with 10 questions similar to those of the initial test (5 theoretical questions and 5 common images).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986110
- Sponsor's protocol ID
- IBYAP22/00008
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Results Obtained in the Regular Clinical Practice of a Clinical Ultrasound Classroom For Primary Care Physicians As a Formative Intervention System
- ClinicalTrials.gov ID
- NCT05986110
- Acronym / sponsor ID
- IBYAP22/00008
- Conditions
- Family Medicine, Clinical Ultrasound, Primary Care
- Keywords
- Family medicine, Clinical ultrasound, Primary care, Resolution improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the project are to evaluate the theoretical-practical knowledge acquired and the degree of satisfaction of a methodology based on theoretical-practical training in abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary Health Care, and to evaluate the benefit obtained by patients over 60 years of age included in the program, analyzing the degree of satisfaction, resolution time of the reason for consultation and decrease in the number of referrals to the second level of care, analyzing the differences by gender.
Detailed description
The objectives of the project are to evaluate the theoretical-practical knowledge acquired and the degree of satisfaction of a methodology based on theoretical-practical training in abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary Health Care, and to evaluate the benefit obtained by patients over 60 years of age included in the program, analyzing the degree of satisfaction, resolution time of the reason for consultation and decrease in the number of referrals to the second level of care, analyzing the differences by gender.
The expected impact is that the doctors participating in the project learn to perform abdominal and thyroid ultrasound and continue to perform them during the year that their participation in the project lasts, and independently thereafter. In addition, this will allow the reduction of interconsultations to the specialized care and emergencies of their patients whose primary care physicians perform ultrasound scans in their health center.
Its application in clinical practice will be reflected because doctors who perform ultrasound scans in their primary care centers will increase their diagnostic certainty in real consultation time on many occasions, thereby reducing interconsultations at the second level of care, and when they have to refer a patient at this level, they will do so in a more documented manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: A training intervention on clinical ultrasound |
| Control Group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- To work in selected health centers.
- To have assigned to more than 800 patients.
- Not have previous training in regulated clinical ultrasound.
- Sign a commitment to Attendance at least 80% of the training program sessions.
- Sign the informed consent.
Key exclusion criteria (2 listed)
- Not meeting any of the inclusion criteria.
- Not signing the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A training intervention on clinical ultrasoundTo train 20 primary care family doctors in clinical ultrasound so that they have greater power of resolution and allow them to limit the diagnostic and surgical times on the waiting lists of their patients. | Procedure or surgery | Intervention Group |
Primary outcome
Assessment of knowledge and skills
Time frame: 1 year
An initial evaluation of knowledge will be carried out prior to the start of the training intervention, which will consist of 10 multiple choice questions with four possible answers with only 1 correct one (5 theoretical questions on the fundamentals and use of ultrasound, and interpretation of 5 images of pathologies or ultrasound anatomy). For the final evaluation, a new test will be carried out, with 10 questions similar to those of the initial test (5 theoretical questions and 5 common images).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A training intervention on clinical ultrasound in people with Family Medicine and Clinical Ultrasound, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Pérez Escanilla (923177831, fperezes@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of knowledge and skills (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.