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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
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vertigo focused on measuring primary care, vertigo, randomized clinical trial

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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