Randomised controlled trials of behavioural nudges delivered through text messages to increase influenza and COVID-19 vaccines among pregnant women (the EPIC study): study protocol.

Infant Female Pregnancy Humans Influenza Vaccines / adverse effects Influenza, Human / prevention & control COVID-19 Vaccines Pregnant Women Text Messaging COVID-19 / prevention & control Victoria Randomized Controlled Trials as Topic
COVID-19 Influenza Pregnancy RCT Randomised controlled trial Vaccine

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
12 Jul 2023
Historique:
received: 10 05 2023
accepted: 28 06 2023
medline: 14 7 2023
pubmed: 13 7 2023
entrez: 12 7 2023
Statut: epublish

Résumé

Influenza and COVID-19 infections during pregnancy may have serious adverse consequences for women as well as their infants. However, uptake of influenza and COVID-19 vaccines during pregnancy remains suboptimal. This study aims to assess the effectiveness of a multi-component nudge intervention to improve influenza and COVID-19 vaccine uptake among pregnant women. Pregnant women who receive antenatal care at five tertiary hospitals in South Australia, Western Australia and Victoria will be recruited to two separate randomised controlled trials (RCTs). Women will be eligible for the COVID-19 RCT is they have received two or less doses of a COVID-19 vaccine. Women will be eligible for the influenza RCT if they have not received the 2023 seasonal influenza vaccine. Vaccination status at all stages of the trial will be confirmed by the Australian Immunisation Register (AIR). Participants will be randomised (1:1) to standard care or intervention group (n = 1038 for each RCT). The nudge intervention in each RCT will comprise three SMS text message reminders with links to short educational videos from obstetricians, pregnant women and midwives and vaccine safety information. The primary outcome is at least one dose of a COVID-19 or influenza vaccine during pregnancy, as applicable. Logistic regression will compare the proportion vaccinated between groups. The effect of treatment will be described using odds ratio with a 95% CI. Behavioural nudges that facilitate individual choices within a complex context have been successfully used in other disciplines to stir preferred behaviour towards better health choices. If our text-based nudges prove to be successful in improving influenza and COVID-19 vaccine uptake among pregnant women, they can easily be implemented at a national level. ClinicalTrials.gov Identifier NCT05613751. Registered on November 14, 2022.

Sections du résumé

BACKGROUND BACKGROUND
Influenza and COVID-19 infections during pregnancy may have serious adverse consequences for women as well as their infants. However, uptake of influenza and COVID-19 vaccines during pregnancy remains suboptimal. This study aims to assess the effectiveness of a multi-component nudge intervention to improve influenza and COVID-19 vaccine uptake among pregnant women.
METHODS METHODS
Pregnant women who receive antenatal care at five tertiary hospitals in South Australia, Western Australia and Victoria will be recruited to two separate randomised controlled trials (RCTs). Women will be eligible for the COVID-19 RCT is they have received two or less doses of a COVID-19 vaccine. Women will be eligible for the influenza RCT if they have not received the 2023 seasonal influenza vaccine. Vaccination status at all stages of the trial will be confirmed by the Australian Immunisation Register (AIR). Participants will be randomised (1:1) to standard care or intervention group (n = 1038 for each RCT). The nudge intervention in each RCT will comprise three SMS text message reminders with links to short educational videos from obstetricians, pregnant women and midwives and vaccine safety information. The primary outcome is at least one dose of a COVID-19 or influenza vaccine during pregnancy, as applicable. Logistic regression will compare the proportion vaccinated between groups. The effect of treatment will be described using odds ratio with a 95% CI.
DISCUSSION CONCLUSIONS
Behavioural nudges that facilitate individual choices within a complex context have been successfully used in other disciplines to stir preferred behaviour towards better health choices. If our text-based nudges prove to be successful in improving influenza and COVID-19 vaccine uptake among pregnant women, they can easily be implemented at a national level.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov Identifier NCT05613751. Registered on November 14, 2022.

Identifiants

DOI: 10.1186/s13063-023-07485-9 PMID: 37438776 PMC: PMC10339598
pubmed: 37438776
doi: 10.1186/s13063-023-07485-9
pii: 10.1186/s13063-023-07485-9
pmc: PMC10339598
doi:

Substances chimiques

Influenza Vaccines 0
COVID-19 Vaccines 0

Banques de données

ClinicalTrials.gov
['NCT05613751']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

454

Subventions

Organisme : National Health and Medical Research Council
ID : APP2014684

Informations de copyright

© 2023. Crown.

Références

Vaccine. 2015 Aug 14;33(34):4191-203
pubmed: 25896385
BMJ. 2010 Mar 18;340:c1279
pubmed: 20299694
Med J Aust. 2019 Jun;210(10):454-462
pubmed: 31006130
BMJ Open. 2022 Aug 18;12(8):e061477
pubmed: 35981769
BMJ. 2020 Sep 1;370:m3320
pubmed: 32873575
JAMA Netw Open. 2021 Jan 4;4(1):e2033472
pubmed: 33443579
BMJ. 2022 May 30;377:o1205
pubmed: 35636775
JAMA Pediatr. 2023 Apr 1;177(4):337-344
pubmed: 36806893
Popul Health Manag. 2022 Aug;25(4):487-500
pubmed: 35353613
Clin Infect Dis. 2019 Apr 24;68(9):1444-1453
pubmed: 30307490
Lancet Infect Dis. 2021 Dec;21(12):1627
pubmed: 34739865
Am J Obstet Gynecol. 2020 Jun;222(6):521-531
pubmed: 32217113
Am J Perinatol. 2022 Oct 19;:
pubmed: 36261065
Vaccine. 2020 Apr 9;38(17):3358-3368
pubmed: 32070678
N Engl J Med. 2021 Jun 17;384(24):2273-2282
pubmed: 33882218
BMC Infect Dis. 2020 Jul 11;20(1):502
pubmed: 32652939
Am J Obstet Gynecol MFM. 2020 May;2(2):100107
pubmed: 32292902
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
JAMA Netw Open. 2018 Sep 7;1(5):e181770
pubmed: 30646151
Vaccine. 2017 Jan 23;35(4):521-528
pubmed: 28024955
Nature. 2021 Sep;597(7876):404-409
pubmed: 34340242
Eur J Med Res. 2021 Sep 28;26(1):116
pubmed: 34583779
Aust N Z J Public Health. 2021 Oct;45(5):455-461
pubmed: 34411398
Value Health. 2022 Jan;25(1):3-9
pubmed: 35031096

Auteurs

Prabha H Andraweera (PH)

Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, SA Health, Adelaide, South Australia, Australia.
Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.
Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.

Bing Wang (B)

Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, SA Health, Adelaide, South Australia, Australia.
Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.
Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.

Margie Danchin (M)

The Royal Children's Hospital, Melbourne, Victoria, Australia.
Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia.

Christopher Blyth (C)

Perth Children's Hospital, Perth, Western Australia, Australia.
Department of Paediatrics, The University of Western Australia, Perth, Western Australia, Australia.

Ivo Vlaev (I)

School of Business, Warwick University, Warwick, UK.

Jason Ong (J)

School of Medicine, Monash University, Melbourne, Victoria, Australia.

Jodie Dodd (J)

Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.
Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
Women's and Babies Division, Women's and Children's Hospital, Adelaide, South Australia, Australia.

Jennifer Couper (J)

Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.
Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
Division of Paediatrics, Women's and Children's Hospital, Adelaide, South Australia, Australia.

Thomas R Sullivan (TR)

South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia.

Jonathan Karnon (J)

Discipline of Public Health, Flinders University, Adelaide, South Australia, Australia.

Nicola Spurrier (N)

Discipline of Paediatrics, Flinders University, Adelaide, South Australia, Australia.
SA Health, South Australian Government, Adelaide, South Australia, Australia.

Michael Cusack (M)

SA Health, South Australian Government, Adelaide, South Australia, Australia.

Dylan Mordaunt (D)

Discipline of Paediatrics, Flinders University, Adelaide, South Australia, Australia.

Dimi Simatos (D)

Discipline of Paediatrics, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.

Gus Dekker (G)

Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.
Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
Discipline of Women's Health, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.

Samantha Carlson (S)

Department of Paediatrics, The University of Western Australia, Perth, Western Australia, Australia.

Jane Tuckerman (J)

Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia.
Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.

Nicholas Wood (N)

Discipline of Paediatrics, University of Sydney, Sydney, New South Wales, Australia.
Children's Hospital Westmead, Sydney, New South Wales, Australia.

Lisa Whop (L)

Discipline of Public Health, Australian National University, Canberra, Australian Capital Territory, Australia.

Helen S Marshall (HS)

Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, SA Health, Adelaide, South Australia, Australia. helen.marshall@adelaide.edu.au.
Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia. helen.marshall@adelaide.edu.au.
Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia. helen.marshall@adelaide.edu.au.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Nourrisson › Randomised controlled trials of behavioural...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Reproduction › Grossesse › Randomised controlled trials of behavioural...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Randomised controlled trials of behavioural...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins antiviraux › Vaccins antigrippaux › Randomised controlled trials of behavioural...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Grippe humaine › Randomised controlled trials of behavioural...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins antiviraux › Vaccins contre la COVID-19 › Randomised controlled trials of behavioural...
questionsmedicales.fr › Personnes › Femmes › Femmes enceintes › Randomised controlled trials of behavioural...
questionsmedicales.fr › Sciences de l'information › Langage › Arts du langage › Écriture › Correspondance comme sujet › Envoi de messages textuels › Randomised controlled trials of behavioural...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Pneumopathie infectieuse › Pneumopathie virale › COVID-19 › Randomised controlled trials of behavioural...
questionsmedicales.fr › Régions géographiques › Océanie › Australasie › Australie › Victoria › Randomised controlled trials of behavioural...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Randomised controlled trials of behavioural...