Clinical trial NCT04929444: Training to Improve Vertigo Management in Primary Care
Official title: Effectiveness of a Training Intervention to Improve the Approach of Patients With Vertigo in Primary Care. VERTAP Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vertigo
Vertigo, Paroxysmal
Keywords: primary care
vertigo
randomized clinical trial
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Catalan Society of Family Medicine
name: Instituto de Salud Carlos III
First posted: 2021-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnostic records
timeFrame: one year
Secondary outcomes:
measure: Derivations to otorhinolaryngologist (ENT) and neurologist
timeFrame: one year
measure: Prescription of antivertiginous medications
timeFrame: One year
measure: Days off work
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: IDIAP JORDI GOL
name: José L Ballve, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.