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CompletedNCT04283383AECAPUpdated Dec 2, 2021

Effectiveness of a Primary Care Clinical Ultrasound Classroom

An interventional study of Primary Care Clinical Ultrasound Classroom (AECAP) in ULTRASONOGRAPHY and PRIMARY CARE, sponsored by Fundacion para la Investigacion y Formacion en Ciencias de la Salud. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2021-12-02.

Sponsored by Fundacion para la Investigacion y Formacion en Ciencias de la Salud · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Sex
All
01

Study 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.

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.

02

Conditions studied

  • ULTRASONOGRAPHY
  • PRIMARY CARE
03

In context

Lead sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. -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

Exclusion criteria

Exclusion Criteria:

1.- No ultrasound availability

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Intervention training

    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.

    Other: Primary Care Clinical Ultrasound Classroom (AECAP)

  • No intervention
    control

Interventions

  • OtherPrimary 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,

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

Secondary outcomes

  1. Evaluation of outcome in clinical practice.

    Diagnostic Delay Times

    Time frame: 1 year

07

Study locations

1 site
  • Primary Care Research Unit of Salamanca
    Salamanca, 37006, Spain
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04283383
Lead sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Responsible party
Sponsor
First posted
Feb 25, 2020
Start date
Jan 1, 2020
Primary completion
Dec 31, 2020
Completion
Nov 30, 2021
Last update
Dec 2, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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