ULTRASONOGRAPHYAECAPNCT04283383
Effectiveness of a Primary Care Clinical Ultrasound Classroom
A study testing Primary Care Clinical Ultrasound Classroom (AECAP) in people with ULTRASONOGRAPHY and PRIMARY CARE, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
Introduction: Clinical ultrasound is a technique that increases diagnostic capacity and facilitates clinical decision making. The objective is to develop and validate an ultrasound training methodology oriented to the clinical practice of the family doctor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ULTRASONOGRAPHY, PRIMARY CARE
- What is being tested?
- Primary Care Clinical Ultrasound Classroom (AECAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 30 Nov 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Physicians should work in a Spanish primary health care center with ultrasound,
- - They must have a list of patients over 800.
- - They must lack prior training in clinical ultrasound.
- - They must sign a commitment of assistance and participation in the AECAP
Who cannot join
- 1.- No ultrasound availability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Primary Care Clinical Ultrasound Classroom for Family Physicians as a Formative Intervention System, a Cuasi Experimental Trial. Study Protocol
Introduction: Clinical ultrasound is a technique that increases diagnostic capacity and facilitates clinical decision making. The objective is to develop and validate an ultrasound training methodology oriented to the clinical practice of the family doctor.
Methods: quasi-experimental study, with before / after design, with a control group and one year of follow-up. 20 family doctors working in primary care Health Centers and with a list of patients over 800 will be included and a control group of similar characteristics will be selected, in terms of age, gender and patient list. A structured training process oriented to the clinical practice of the family physician, Primary Care Clinical Ultrasound Classroom (AECAP) will be carried out, and the improvement of knowledge and skills will be evaluated, as well as the improvement of quality of care based on clinical indicators.
Discussion: The Family Physician is in a privileged situation to increase the performance of the ultrasound in frequent clinical situations and allows a reduction of the attention times. Investigators hope that the results obtained in this study demonstrate the effectiveness of the structured training method (AECAP) and support the generalization of ultrasound in Primary Health Care.
Read the detailed description
2.1. Design and scope This is a quasi-experimental study, with a before / after design, in which a control group It will be used, with one year of follow-up to evaluate the effectiveness of the training intervention in clinical ultrasound to family doctors. The control group will be composed of family doctors of similar characteristics, who do not participate in the AECAP. The project will be developed with family doctors working in Spanish primary health care centers.
2.2. Study population 20 family doctors who want to participate voluntarily and meet the following inclusion criteria will be included in the study: 1) Physicians should work in a Spanish primary health care center where there is an availability of ultrasound, belonging to the Health Service of Castilla and León (Sacyl) and the Salamanca Health Area. 2.- They must have a list of patients over 800. 3.- Participants must lack prior training in clinical ultrasound. 4.- Participantsmust sign a commitment of assistance and participation in the AECAP. A selection of the control group will be made, with family doctors of similar characteristics, in terms of age, gender, training, work center and number of assigned patients. Participants will be recruited in the first quarter of 2020.
2.3.-Intervention The intervention designed in the AECAP consists of a basic structure and a specific methodology, which will be developed in the teaching classroom of the San Juan Health Center in Salamanca.
Structure: The Material necessary for the realization of the training activity will be: Esaote MyLab ™ Six Echograph (Esaote Spain, Barcelona, Spain); Esaote MyLab ™ Gamma portable ultrasound, a 56-inch high resolution TV with HDMI connection to ultrasound; Fixed computer connected to ultrasound and TV and examination table.
AECAP training methodology: The ultrasound classroom will be biweekly, on the second and fourth Tuesdays of each month, from 6:00 p.m. to 8:30 p.m. At the beginning of the AECAP, the necessary material will be delivered to individually complete the ultrasound training and will be developed with the following structure.
Basic course of clinical ultrasound (abdominal and thyroid) lasting 30 hours, of which 15 hours are theoretical and 15 hours are practical. The course will take place in the first quarter of 2020.
Clinical sessions with patients. At this stage, participants verify the practical usefulness of clinical ultrasound through clinical cases with real patients, who have agreed to participate by signing the informed consent. The sessions will be presented following a structured clinical methodology with a clinical session format with a real patient with the following steps. Before the patient enters the classroom, the clinical case is presented to the participating physicians, then the patient enters to perform the ultrasound with visualization on the classroom screen and written report on the result (Figure 1). All data is incorporated into the "Case Presentation Model. This phase will take place from April to October 2020. The monitor of each session will collect the informed consent of the participating patients.
Final practice: All students must present during the training process, a clinical case in which the use of ultrasound is useful for diagnosis, which will be used to assess the training process. In each clinical case the following variables will be recorded: relevance of ultrasound in the case, agreement of results with clinical data and registration of therapeutic plan and need to perform ultrasound by radiology service or the request for other imaging tests (CT, MRI) ) and endoscopies.
Evaluation of the intervention: Primary and secondary outcomes Primary results: Assessment of knowledge and skills. An initial knowledge evaluation will be carried out, prior to the beginning of the training intervention consisting of 10 single-type test questions: 5 theoretical questions about the basis and use of ultrasound and 5 images to interpret pathologies or ultrasound anatomy. Once the training sessions and practices are started, a continuous evaluation system will be used through which students will be evaluated by teachers / monitors, assessing in a standardized way, theoretical, practical and interpretative aspects. For the final evaluation, on the one hand, a new test of 10 test questions similar to the initial one (5 of theory and 5 of common images) will be carried out. On the other hand, there will be a structured assessment of the presentation of the final clinical case by each student. Finally, the ultrasound examination of 6 patients with common pathologies or normal ultrasound, who have an abdominal or thyroid ultrasound, previously informed by the radiology service, assessing concordance in the description, measures and diagnosis will be assessed.
- Conditions
- ULTRASONOGRAPHY, PRIMARY CARE
- Being tested
- Primary Care Clinical Ultrasound Classroom (AECAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care Clinical Ultrasound Classroom (AECAP)Other
A structured training process oriented to the clinical practice of the family physician, Primary Care Clinical Ultrasound Classroom (AECAP) will be carried out,
| Study group | Role | What they receive |
|---|---|---|
| Intervention training | Experimental | A structured training process oriented to the clinical practice of the family physician, Primary Care Clinical Ultrasound Classroom (AECAP) will be carried out, and the improvement of knowledge and skills will be evaluated, as well as the improvement of quality of care based on clinical indicators. Receives: Other: Primary Care Clinical Ultrasound Classroom (AECAP) |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Knowledge by questionaire
A knowledge assessment will be carried out, prior to the start of the training intervention consisting of 10 single-type test questions
Measured: 1 year
Secondary outcomes (1)
Evaluation of outcome in clinical practice.
Diagnostic Delay Times
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 posted25 Feb 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ULTRASONOGRAPHYStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- quasi-experimental study,
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
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
- NCT04283383
- Sponsor's protocol ID
- GRS 1824 B 18
- Acronym
- AECAP
- Status last verified
- Nov 2021
- First submitted
- 20 Feb 2020
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Diego-Dominguez F, Torrecilla-Garcia M, Casado-Huerga J, Paule-Sanchez MA, Soria-Lopez CI, Iglesias-Clemente JM, de Dios-Hernandez JM, Diego-Mangas N, Cubillo-Jimenez M, Perez-Escanilla F. Effectiveness of a primary care clinical ultrasound classroom for family physicians as a formative intervention system, a quasi-experimental trial: Study protocol. Medicine (Baltimore). 2020 Jul 2;99(27):e19914. doi: 10.1097/MD.0000000000019914.
PubMed 32629625
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Primary Care Clinical Ultrasound Classroom for Family Physicians as a Formative Intervention System, a Cuasi Experimental Trial. Study Protocol
- ClinicalTrials.gov ID
- NCT04283383
- Acronym / sponsor ID
- AECAP / GRS 1824 B 18
- Conditions
- ULTRASONOGRAPHY, PRIMARY CARE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 25 Feb 2020 (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.
Introduction: Clinical ultrasound is a technique that increases diagnostic capacity and facilitates clinical decision making. The objective is to develop and validate an ultrasound training methodology oriented to the clinical practice of the family doctor.
Methods: quasi-experimental study, with before / after design, with a control group and one year of follow-up. 20 family doctors working in primary care Health Centers and with a list of patients over 800 will be included and a control group of similar characteristics will be selected, in terms of age, gender and patient list. A structured training process oriented to the clinical practice of the family physician, Primary Care Clinical Ultrasound Classroom (AECAP) will be carried out, and the improvement of knowledge and skills will be evaluated, as well as the improvement of quality of care based on clinical indicators.
Discussion: The Family Physician is in a privileged situation to increase the performance of the ultrasound in frequent clinical situations and allows a reduction of the attention times. Investigators hope that the results obtained in this study demonstrate the effectiveness of the structured training method (AECAP) and support the generalization of ultrasound in Primary Health Care.
Detailed description
2.1. Design and scope This is a quasi-experimental study, with a before / after design, in which a control group It will be used, with one year of follow-up to evaluate the effectiveness of the training intervention in clinical ultrasound to family doctors. The control group will be composed of family doctors of similar characteristics, who do not participate in the AECAP. The project will be developed with family doctors working in Spanish primary health care centers.
2.2. Study population 20 family doctors who want to participate voluntarily and meet the following inclusion criteria will be included in the study: 1) Physicians should work in a Spanish primary health care center where there is an availability of ultrasound, belonging to the Health Service of Castilla and León (Sacyl) and the Salamanca Health Area. 2.- They must have a list of patients over 800. 3.- Participants must lack prior training in clinical ultrasound. 4.- Participantsmust sign a commitment of assistance and participation in the AECAP. A selection of the control group will be made, with family doctors of similar characteristics, in terms of age, gender, training, work center and number of assigned patients. Participants will be recruited in the first quarter of 2020.
2.3.-Intervention The intervention designed in the AECAP consists of a basic structure and a specific methodology, which will be developed in the teaching classroom of the San Juan Health Center in Salamanca.
Structure: The Material necessary for the realization of the training activity will be: Esaote MyLab ™ Six Echograph (Esaote Spain, Barcelona, Spain); Esaote MyLab ™ Gamma portable ultrasound, a 56-inch high resolution TV with HDMI connection to ultrasound; Fixed computer connected to ultrasound and TV and examination table.
AECAP training methodology: The ultrasound classroom will be biweekly, on the second and fourth Tuesdays of each month, from 6:00 p.m. to 8:30 p.m. At the beginning of the AECAP, the necessary material will be delivered to individually complete the ultrasound training and will be developed with the following structure.
Basic course of clinical ultrasound (abdominal and thyroid) lasting 30 hours, of which 15 hours are theoretical and 15 hours are practical. The course will take place in the first quarter of 2020.
Clinical sessions with patients. At this stage, participants verify the practical usefulness of clinical ultrasound through clinical cases with real patients, who have agreed to participate by signing the informed consent. The sessions will be presented following a structured clinical methodology with a clinical session format with a real patient with the following steps. Before the patient enters the classroom, the clinical case is presented to the participating physicians, then the patient enters to perform the ultrasound with visualization on the classroom screen and written report on the result (Figure 1). All data is incorporated into the "Case Presentation Model. This phase will take place from April to October 2020. The monitor of each session will collect the informed consent of the participating patients.
Final practice: All students must present during the training process, a clinical case in which the use of ultrasound is useful for diagnosis, which will be used to assess the training process. In each clinical case the following variables will be recorded: relevance of ultrasound in the case, agreement of results with clinical data and registration of therapeutic plan and need to perform ultrasound by radiology service or the request for other imaging tests (CT, MRI) ) and endoscopies.
Evaluation of the intervention: Primary and secondary outcomes Primary results: Assessment of knowledge and skills. An initial knowledge evaluation will be carried out, prior to the beginning of the training intervention consisting of 10 single-type test questions: 5 theoretical questions about the basis and use of ultrasound and 5 images to interpret pathologies or ultrasound anatomy. Once the training sessions and practices are started, a continuous evaluation system will be used through which students will be evaluated by teachers / monitors, assessing in a standardized way, theoretical, practical and interpretative aspects. For the final evaluation, on the one hand, a new test of 10 test questions similar to the initial one (5 of theory and 5 of common images) will be carried out. On the other hand, there will be a structured assessment of the presentation of the final clinical case by each student. Finally, the ultrasound examination of 6 patients with common pathologies or normal ultrasound, who have an abdominal or thyroid ultrasound, previously informed by the radiology service, assessing concordance in the description, measures and diagnosis will be assessed.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- quasi-experimental study,
| Arm | Type | Receives |
|---|---|---|
| Intervention training | Experimental | Other: Primary Care Clinical Ultrasound Classroom (AECAP)A structured training process oriented to the clinical practice of the family physician, Primary Care Clinical Ultrasound Classroom (AECAP) will be carried out, and the improvement of knowledge and skills will be evaluated, as well as the improvement of quality of care based on clinical indicators. |
| control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- -Physicians should work in a Spanish primary health care center with ultrasound,
- - They must have a list of patients over 800.
- - They must lack prior training in clinical ultrasound.
- - They must sign a commitment of assistance and participation in the AECAP
Key exclusion criteria (1 listed)
- 1.- No ultrasound availability
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 |
|---|---|---|
| Primary Care Clinical Ultrasound Classroom (AECAP)A structured training process oriented to the clinical practice of the family physician, Primary Care Clinical Ultrasound Classroom (AECAP) will be carried out, | Other | Intervention training |
Primary outcome
Evaluation of Knowledge by questionaire
Time frame: 1 year
A knowledge assessment will be carried out, prior to the start of the training intervention consisting of 10 single-type test questions
1 secondary outcome
Evaluation of outcome in clinical practice.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Derived from this study: PubMed 32629625Diego-Dominguez F, Torrecilla-Garcia M, Casado-Huerga J, Paule-Sanchez MA, Soria-Lopez CI, Iglesias-Clemente JM, de Dios-Hernandez JM, Diego-Mangas N, Cubillo-Jimenez M, Perez-Escanilla F. Effectiveness of a primary care clinical ultrasound classroom for family physicians as a formative intervention system, a quasi-experimental trial: Study protocol. Medicine (Baltimore). 2020 Jul 2;99(27):e19914. doi: 10.1097/MD.0000000000019914.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Care Clinical Ultrasound Classroom (AECAP) in people with ULTRASONOGRAPHY and PRIMARY CARE, 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 2 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Knowledge by questionaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283383, which also lists 1 linked publication.
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 2 Dec 2021.