Training to Improve Vertigo Management in Primary Care (VERTAP)
Primary Purpose
Vertigo, Vertigo, Paroxysmal
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training on vertigo
Sponsored by
About this trial
This is an interventional diagnostic trial for Vertigo focused on measuring primary care, vertigo, randomized clinical trial
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Training group
Common Practice
Arm Description
The professionals of the primary care teams that are in Intervention group would receive the training at the beginning of the study
The professionals of the primary care teams that are in Control group will be offered the training after the conclusion of the study
Outcomes
Primary Outcome Measures
Diagnostic records
proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis
Secondary Outcome Measures
Derivations to otorhinolaryngologist (ENT) and neurologist
Number of referrals made during the study period
Prescription of antivertiginous medications
Number of prescriptions of betahistine, sulpiride, dimenhydrinate made during the study period
Days off work
Number of days off work caused by vertigo-related illnesses during the study period
Full Information
NCT ID
NCT04929444
First Posted
June 7, 2021
Last Updated
June 10, 2021
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Catalan Society of Family Medicine, Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT04929444
Brief Title
Training to Improve Vertigo Management in Primary Care
Acronym
VERTAP
Official Title
Effectiveness of a Training Intervention to Improve the Approach of Patients With Vertigo in Primary Care. VERTAP Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Catalan Society of Family Medicine, Instituto de Salud Carlos III
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, Vertigo, Paroxysmal
Keywords
primary care, vertigo, randomized clinical trial
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training group
Arm Type
Active Comparator
Arm Description
The professionals of the primary care teams that are in Intervention group would receive the training at the beginning of the study
Arm Title
Common Practice
Arm Type
No Intervention
Arm Description
The professionals of the primary care teams that are in Control group will be offered the training after the conclusion of the study
Intervention Type
Other
Intervention Name(s)
Training on vertigo
Intervention Description
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
Primary Outcome Measure Information:
Title
Diagnostic records
Description
proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis
Time Frame
one year
Secondary Outcome Measure Information:
Title
Derivations to otorhinolaryngologist (ENT) and neurologist
Description
Number of referrals made during the study period
Time Frame
one year
Title
Prescription of antivertiginous medications
Description
Number of prescriptions of betahistine, sulpiride, dimenhydrinate made during the study period
Time Frame
One year
Title
Days off work
Description
Number of days off work caused by vertigo-related illnesses during the study period
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Peguero, MD. PHD
Phone
#34630053772
Email
pegueroeva@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José L Ballve, MD, PHD
Organizational Affiliation
IDIAP JORDI GOL
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
35906606
Citation
Patino JEP, Moreno JLB, Matos YR, Ortega JA, Puertolas OC, Munoz RC, Balboa IV, Compta XG, Agudelo OLA, Munoz SC, Rodriguez VM, Cortes AN, Rodriguez EP. Effectiveness of a training intervention to improve the management of vertigo in primary care: a multicentre cluster-randomised trial, VERTAP. Trials. 2022 Jul 29;23(1):608. doi: 10.1186/s13063-022-06548-7. Erratum In: Trials. 2022 Sep 21;23(1):793.
Results Reference
derived
Learn more about this trial
Training to Improve Vertigo Management in Primary Care
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