Health Education Clinical Trial
Official title:
Effectiveness of a Brief Intervention for Acceptance of Influenza Vaccine in the Primary Care Setting
Influenza virus has high morbidity rates during annual epidemics, with certain high-risk
groups being particularly susceptible to complications and mortality. Vaccination is the main
prevention measure, alongside with hygiene measures. Nevertheless, vaccine coverage remains
low.
Some studies suggest that short, standardized interventions can improve coverage of several
vaccines.
Hypothesis: Brief Intervention is an effective tool in improving vaccination coverage in
people who have initially rejected it.
Objective: To determine the effectiveness of a Brief Intervention in increasing influenza
vaccination (IIV) coverage compared with the usual advice in people who refuse it.
Method: cluster randomized clinical trial. The study population was individuals with high
risk factors who initially refused the influenza vaccine. Professionals participants (doctors
and nurses) were assigned randomly to the intervention group (brief intervention) and the
control group (usual advice).
General objective: To determine the effectiveness of the use of BI for IIV compared to the
usual advice, in people who refuse to be vaccinated.
Specific objectives:
1. To examine the effectiveness of Brief Intervention compared to the usual advice in
different risk groups (> 60 healthy, > 60 years old with a Risk Factor [RF], <60 years
old with RF).
2. Quantify influenza vaccine coverage in people with the most frequent RF.
3. Record the patients' reasons for refusing to be vaccinated.
METHOD A cluster randomized controlled clinical trial. The reference population consisted of
patients assigned to and treated by urban and rural health centres in the centre of
Catalonia, an area with a population of approximately 405,000. 135,648 were the risk factor
population that could be vaccinated against influenza virus.
The study population consisted of individuals with high risk factors who were treated in
healthcare centres during the 2017 influenza campaign.
The study protocol was approved by the Research Ethics Committee (CEI) of the Institut
Universitari d'Investigació en Atenció Primària (IDIAP Jordi Gol).
The participants (doctors and nurses) decided voluntarily whether or not to participate and
they were randomly assigned to either the Intervention Group (IG) or the Control Group (CG).
The recruitment of patients suitable to participate in the study was carried out during the
IIV campaign, as part of the health centre's routine activities. Patients with inclusion
criteria who came to see a doctor or nurse were invited to participate in the study. Those
who accepted participating signed an informed consent.
The intervention consisted of a standardized Brief Intervention for the Influenza
Vaccination.
Data was collected anonymously and confidentially via the electronic health record of
Catalonia [eCAP in Catalan]. The variables analysed for the two groups were: IIV at the end
of the 2017 vaccination campaign (yes/no), age, IIV risk factors and reasons for
non-vaccination.
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