Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04283383 |
| Other study ID # |
GRS 1824 B 18 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Fundacion para la Investigacion y Formacion en Ciencias de la Salud |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
