Clinical trial NCT04568785: 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
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Vaccination
Health Education
Keywords: directive counseling
health education
influenza vaccines
primary health care
vaccination coverage
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 524
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

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.

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.

Primary outcomes:
measure: Influenza vaccination status at the end of the Influenza vaccination campaign 2017.
timeFrame: up to 3 months
measure: Influenza vaccination status of the participants who received the Brief Intervention or the normal advice.
timeFrame: up to 3 months
Secondary outcomes:
measure: Reasons for rejecting Influenza Vaccination
timeFrame: one day
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: CAP Plaça Catalunya- Manresa 2
state: Barcelona
Study officials:
References:
citation: 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.
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.
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
citation: 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.
citation: European Centre for Disease Prevention and Control. Catalogue of interventions addressing vaccine hesitancy. Stockholm: ECDC; 2017. doi: 10.2900/654210
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. doi: 10.1016/s0749-3797(02)00415-4.
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.
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.
citation: 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.
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.
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.
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
citation: 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.
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(5):CD005188. doi: 10.1002/14651858.CD005188.pub4.