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

Primary Purpose

Influenza Vaccination, Health Education

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Brief Intervention for Influenza vaccine
Normal advice
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Influenza Vaccination focused on measuring directive counseling, health education, influenza vaccines, primary health care, vaccination coverage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CAP Plaça Catalunya- Manresa 2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brief Intervention group

Control group

Arm Description

Intervention consisted of a standardized Brief Intervention, which varied depending on the reason the patient had given for refusing the vaccination.

the control group intervention was the normal advice that professionals used to give their patients

Outcomes

Primary Outcome Measures

Influenza vaccination status at the end of the Influenza vaccination campaign 2017.
% of reluctant patients vaccinated against Influenza at the end of the campaign 2017. Measurement tool: Influenza vaccine registered in patient's medical history
Influenza vaccination status of the participants who received the Brief Intervention or the normal advice.
% 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

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

Full Information

First Posted
September 14, 2020
Last Updated
September 23, 2020
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT04568785
Brief Title
Effectiveness of a Brief Intervention for Acceptance of Influenza Vaccine in the Primary Care Setting
Official Title
Effectiveness of a Brief Intervention for Acceptance of Influenza Vaccine in the Primary Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Vaccination, Health Education
Keywords
directive counseling, health education, influenza vaccines, primary health care, vaccination coverage

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
524 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Intervention group
Arm Type
Experimental
Arm Description
Intervention consisted of a standardized Brief Intervention, which varied depending on the reason the patient had given for refusing the vaccination.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
the control group intervention was the normal advice that professionals used to give their patients
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention for Influenza vaccine
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Normal advice
Intervention Description
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 Measure Information:
Title
Influenza vaccination status at the end of the Influenza vaccination campaign 2017.
Description
% of reluctant patients vaccinated against Influenza at the end of the campaign 2017. Measurement tool: Influenza vaccine registered in patient's medical history
Time Frame
up to 3 months
Title
Influenza vaccination status of the participants who received the Brief Intervention or the normal advice.
Description
% 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
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Reasons for rejecting Influenza Vaccination
Description
% of the different reasons for rejecting Influenza Vaccination. Measurement tool: specific questionnaire.
Time Frame
one day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
CAP Plaça Catalunya- Manresa 2
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08242
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://salutpublica.gencat.cat/web/.content/minisite/aspcat/promocio_salut/vacunacions/06vacunacio-antigripal/informacio-de-temporada/ASPCAT-GUIA-CAMPANYA-GRIP.pdf
Description
Guide for the Influenza vaccination campaign in Catalonia

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

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