Analysis of the Results Obtained in the Regular Clinical... | NCT05986110

Studies
Analysis of the Results Obtained in the Regular Clinical Practice of a Clinical Ultrasound Classroom For Primary Care Physicians As a Formative Intervention System

NCT05986110

Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Status

Unknown status

Last Update Posted

Aug 14, 2023Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Family Medicine
Clinical Ultrasound
Primary Care

Interventions

A training intervention on clinical ultrasound

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jun 29, 2023

First Submission Date that Met QC Criteria

Aug 9, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2023

Last Update Posted Date

Aug 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la SaludOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental		Procedure: A training intervention on clinical ultrasound
Control Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A training intervention on clinical ultrasound	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Not meeting any of the inclusion criteria.
Not signing the informed consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fernando Pérez Escanilla	Contact	923177831		fperezes@saludcastillayleon.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Primary Care Research Unit of Salamanca	Recruiting	Salamanca		37006	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.