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OpenTrials
Completed

NCT Number: NCT04568785

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).

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Key information

Conditions

Influenza Vaccination Adherence Interventions Behavior Health Behavior Health Education Infections Influenza, Human Medication Adherence Orthomyxoviridae Infections Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAP Plaça Catalunya- Manresa 2

Manresa, Barcelona, 08242, Spain

About this study

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:

  • 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).
  • Quantify influenza vaccine coverage in people with the most frequent RF.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Intervention for Influenza vaccine

Behavioral

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.

Normal advice

Behavioral

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 outcomes

  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 outcomes

  1. Reasons for rejecting Influenza Vaccination

    Time frame: one day

    % of the different reasons for rejecting Influenza Vaccination. Measurement tool: specific questionnaire.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 29, 2020
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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