Training to Improve Vertigo Management in Primary Care

Vertigo Clinical Trial

— VERTAP  

Official title:

Effectiveness of a Training Intervention to Improve the Approach of Patients With Vertigo in Primary Care. VERTAP Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04929444
• Other study ID #: 4R21/003
• Secondary ID: PI19/00736
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2021
• Source: Jordi Gol i Gurina Foundation
• Contact: Eva Peguero, MD. PHD
• Phone: #34630053772
• Email: pegueroeva[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: To verify the effectiveness of a blended course in PC to improve adherence to clinical practice guidelines.

Design: randomized community trial, by clusters (control group -CG- / intervention group -IG-) Scope: 20 PCT (primary care teams)(10 per group) Outcome variables will be: Diagnostic records (proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis); Derivations to otorhinolaryngologist (ENT) and neurologist; Prescription of antivertiginous medications and Number of days off work caused by vertigo-related.

Statistical analysis:Descriptive statistics of all the baseline variables will be carried out and, the differences between groups in the post-intervention outcome variables will be evaluated through the t-test. In the IG, a multivariate logistic regression model will identify response patterns based on the baseline variables of professionals and centers

Description:

Vertigo is a prevalent pathology whose most frequent cause is benign paroxysmal positional vertigo (BPPV). Treatment of this disease are the relocation manoeuvres. Although these manoeuvres are effective in primary care (PC), they are not done routinely. Attention to other causes of vertigo in PC also has a wide margin for improvement. Objectives: To verify the effectiveness of a blended course in PC to improve adherence to clinical practice guidelines. Design: randomized community trial, by clusters (CG / IG), multicenter and open, taking as unit of allocation the primary care team (PCT). The professionals of the PCT that are in IG would receive the training at the beginning of the study and those of the control group will be offered after the conclusion of the same. Scope: 20 PCT (10 per group) selected from the "Costa de Ponent" Primary Care Directorate of the Catalan Health Institute. Variables: The outcome variables will be: Diagnostic records (proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis); Derivations to otorhinolaryngologist (ENT) and neurologist; Prescription of antivertiginous medications and Number of days off work caused by vertigo-related illnesses during the study period. Other study variables will be characteristics of the professionals (age, sex) and centers (teachers, number of tutors, rural / urban). All the variables will be collected in an aggregated form by computerized data download during the year following the training intervention in the PCT. Statistical analysis: Following the CONSORT Cluster Guide, the baseline comparability of the two study groups will be analyzed to analyze the homogeneity. Descriptive statistics of all the baseline variables will be carried out and, the differences between groups in the post-intervention outcome variables will be evaluated through the t-test. In the IG, a multivariate logistic regression model will identify response patterns based on the baseline variables of professionals and centers. Conclusions: Positive results of the study could imply a paradigm shift in the approach to vertigo in primary care, which would be easy to extend to other areas since the most important part of the training course will be done online.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 20 randomized primary care teams out of the 56 that make up the "Costa de Ponent" Primary Care Department that serve a population of 1.3 million people.

Exclusion Criteria:

• Primary care teams in which> 60% of their professionals have received a course on vertigo in the last 5 years will be excluded.

• Primary care teams who are not interested in participating in the study will be excluded

Related Conditions & MeSH terms

• Dizziness
• Vertigo
• Vertigo, Paroxysmal

Intervention

Other:
• Training on vertigo
Online training on vertigo management in primary care with a face-to-face session. On the one hand, the course will contain theoretical content and clinical cases will be used as the methodology of the course, with feedback paths for each correct or incorrect answer from the students and videos recorded expressly for the course. In addition, there will be a face-to-face session where all participants must perform the diagnostic and therapeutic maneuvers proposed in the course, to evaluate the use of the training and also to standardize the way of doing them for the study

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Catalan Society of Family Medicine, Instituto de Salud Carlos III

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic records	proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis	one year
Secondary	Derivations to otorhinolaryngologist (ENT) and neurologist	Number of referrals made during the study period	one year
Secondary	Prescription of antivertiginous medications	Number of prescriptions of betahistine, sulpiride, dimenhydrinate made during the study period	One year
Secondary	Days off work	Number of days off work caused by vertigo-related illnesses during the study period	One year