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

NCT04568785 | Completed

• 1 other identifier: P17/224
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

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).

Conditions

Influenza Vaccination; Health Education

Keywords

directive counseling; health education; influenza vaccines; primary health care; vaccination coverage

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Reasons for rejecting Influenza Vaccination

  one day

Study Arms (2)

Brief Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Behavioral: Normal advice

Interventions

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.

Brief Intervention group

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.

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

CAP Plaça Catalunya- Manresa 2

Manresa, Barcelona, 08242, Spain

Location

Related 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.

  PMID: 21756960 BACKGROUND

• 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.

  PMID: 27255466 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22535855 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 11988383 BACKGROUND

• 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.

  PMID: 24423245 BACKGROUND

• 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.

  PMID: 27667330 BACKGROUND

• 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.

  PMID: 19684629 BACKGROUND

• 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.

  PMID: 25012957 BACKGROUND

• 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.

  PMID: 25585065 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25499651 BACKGROUND

• 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.

  PMID: 29845606 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Health Education

Interventions

Crisis Intervention; Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Health Care Nurse

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 29, 2020
• Study Start: October 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: March 31, 2018
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)