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

Health Education Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568785
• Other study ID #: P17/224
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: September 2020
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: March 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Education
• Influenza Vaccination
• Influenza, Human

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	CAP Plaça Catalunya- Manresa 2	Manresa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Bish A, Yardley L, Nicoll A, Michie S. Factors associated with uptake of vaccination against pandemic influenza: a systematic review. Vaccine. 2011 Sep 2;29(38):6472-84. doi: 10.1016/j.vaccine.2011.06.107. Epub 2011 Jul 12. Review. — View Citation

Bonafide KE, Vanable PA. Male human papillomavirus vaccine acceptance is enhanced by a brief intervention that emphasizes both male-specific vaccine benefits and altruistic motives. Sex Transm Dis. 2015 Feb;42(2):76-80. doi: 10.1097/OLQ.0000000000000226. — View Citation

Chan SS, Leung DY, Leung AY, Lam C, Hung I, Chu D, Chan CK, Johnston J, Liu SH, Liang R, Lam TH, Yuen KY. A nurse-delivered brief health education intervention to improve pneumococcal vaccination rate among older patients with chronic diseases: a cluster randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):317-24. doi: 10.1016/j.ijnurstu.2014.06.008. Epub 2014 Jun 19. — View Citation

European Centre for Disease Prevention and Control. Catalogue of interventions addressing vaccine hesitancy. Stockholm: ECDC; 2017. doi: 10.2900/654210

Ferguson PE, Jordens CF, Gilroy NM. Patient and family education in HSCT: improving awareness of respiratory virus infection and influenza vaccination. A descriptive study and brief intervention. Bone Marrow Transplant. 2010 Apr;45(4):656-61. doi: 10.1038/bmt.2009.209. Epub 2009 Aug 17. — View Citation

Giese C, Mereckiene J, Danis K, O'Donnell J, O'Flanagan D, Cotter S. Low vaccination coverage for seasonal influenza and pneumococcal disease among adults at-risk and health care workers in Ireland, 2013: The key role of GPs in recommending vaccination. Vaccine. 2016 Jul 12;34(32):3657-62. doi: 10.1016/j.vaccine.2016.05.028. Epub 2016 Jun 7. — View Citation

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

Nyhan B, Reifler J. Does correcting myths about the flu vaccine work? An experimental evaluation of the effects of corrective information. Vaccine. 2015 Jan 9;33(3):459-64. doi: 10.1016/j.vaccine.2014.11.017. Epub 2014 Dec 8. — View Citation

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

Stockwell MS, Kharbanda EO, Martinez RA, Vargas CY, Vawdrey DK, Camargo S. Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population: a randomized controlled trial. JAMA. 2012 Apr 25;307(16):1702-8. doi: 10.1001/jama.2012.502. — View Citation

Thomas RE, Lorenzetti DL. Interventions to increase influenza vaccination rates of those 60 years and older in the community. Cochrane Database Syst Rev. 2018 May 30;5:CD005188. doi: 10.1002/14651858.CD005188.pub4. Review. — View Citation

Whitlock EP, Orleans CT, Pender N, Allan J. Evaluating primary care behavioral counseling interventions: an evidence-based approach. Am J Prev Med. 2002 May;22(4):267-84. Review. — View Citation

Wong VW, Fong DY, Tarrant M. Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2014 Jan 14;14:19. doi: 10.1186/1471-2393-14-19. — View Citation

Wong VWY, Fong DYT, Lok KYW, Wong JYH, Sing C, Choi AY, Yuen CYS, Tarrant M. Brief education to promote maternal influenza vaccine uptake: A randomized controlled trial. Vaccine. 2016 Oct 17;34(44):5243-5250. doi: 10.1016/j.vaccine.2016.09.019. Epub 2016 Sep 22. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 3 months
Primary	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	up to 3 months
Secondary	Reasons for rejecting Influenza Vaccination	% of the different reasons for rejecting Influenza Vaccination. Measurement tool: specific questionnaire.	one day

External Links

•   Guide for the Influenza vaccination campaign in Catalonia