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

September 23, 2020 updated by: Raquel Muñoz Miralles, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

524

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Manresa, Barcelona, Spain, 08242
        • CAP Plaça Catalunya- Manresa 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 3 months
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
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for rejecting Influenza Vaccination
Time Frame: one day
% of the different reasons for rejecting Influenza Vaccination. Measurement tool: specific questionnaire.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P17/224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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