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Effectiveness of a Brief Intervention for Acceptance of Influenza Vaccine in the Primary Care Setting

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ClinicalTrials.gov Identifier: NCT04568785
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Raquel Muñoz Miralles, Jordi Gol i Gurina Foundation

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Influenza Vaccination Health Education Behavioral: Brief Intervention for Influenza vaccine Behavioral: Normal advice Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 524 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness of a Brief Intervention for Acceptance of Influenza Vaccine in the Primary Care Setting
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Brief Intervention group
Intervention consisted of a standardized Brief Intervention, which varied depending on the reason the patient had given for refusing the vaccination.
Behavioral: Brief Intervention for Influenza vaccine
Previous to the intervention, patients were asked about the reasons to reject the influenza vaccine. Brief Intervention was performed by the healthcare professional during the consultation. It was given verbally, with written support.

Active Comparator: Control group
the control group intervention was the normal advice that professionals used to give their patients
Behavioral: Normal advice
In the CG the influenza vaccine advice was the normal advice that professionals used to give their patients and was not asked for the reasons for the rejection of the vaccine to prevent them from influencing the advice.




Primary Outcome Measures :
  1. Influenza vaccination status at the end of the Influenza vaccination campaign 2017. [ Time Frame: up to 3 months ]
    % of reluctant patients vaccinated against Influenza at the end of the campaign 2017. Measurement tool: Influenza vaccine registered in patient's medical history

  2. Influenza vaccination status of the participants who received the Brief Intervention or the normal advice. [ Time Frame: up to 3 months ]
    % of reluctant patients vaccinated against Influenza in the Intervention group or in the Control group. Measurement tool: Influenza vaccine registered in patient's medical history


Secondary Outcome Measures :
  1. Reasons for rejecting Influenza Vaccination [ Time Frame: one day ]
    % of the different reasons for rejecting Influenza Vaccination. Measurement tool: specific questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals in high-risk groups for influenza (paediatric and adult)
  • Not intending to be vaccinated against the influenza virus during the current season.
  • Informed consent to participate. In case of paediatric patients, parents signed the consent and made decisions about vaccination.

Exclusion Criteria:

  • Language barrier
  • Mental or physical conditions which make it difficult for the patient or their relatives to make decisions.
  • Having previously participated in the pilot study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568785


Locations
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Spain
CAP Plaça Catalunya- Manresa 2
Manresa, Barcelona, Spain, 08242
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Additional Information:
Publications:
Picazo J, González Romo F, Salleras Sanmartí J, Bayas Rodríguez J, Álvarez Pasquín M. Encuesta sobre la vacunación de adultos en España. Gripe y neumococo. Vacunas. 2012; 13(3): 100-111. doi.10.1016/S1576-9887(12)70048-1
European Centre for Disease Prevention and Control. Catalogue of interventions addressing vaccine hesitancy. Stockholm: ECDC; 2017. doi: 10.2900/654210
Muñoz-Miralles R, Bonvehí Nadeu S, Sant Masoliver C, Martín Gallego A, Llamazares Robles MO, Mendioroz Peña J. Efectividad del consejo breve en la vacunación contra la gripe. Estudio piloto en atención primaria. Vacunas. 2019; 20(1): 18-24. doi.10.1016/j.vacun.2019.01.001

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Responsible Party: Raquel Muñoz Miralles, Primary Health Care Nurse, Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT04568785    
Other Study ID Numbers: P17/224
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raquel Muñoz Miralles, Jordi Gol i Gurina Foundation:
directive counseling
health education
influenza vaccines
primary health care
vaccination coverage
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases