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Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children
Pregnant women and children with chronic medical conditions are at increased risk of hospitalisation, intensive care admission and death from influenza and COVID-19 infections. However, there appears to be a high level of vaccine hesitancy among women of reproductive age. We will develop "nudge" interventions to improve influenza and COVID vaccine uptake and test the effectiveness of the interventions using randomised controlled trials in * pregnant women * medically at risk children.
Study details:
Pregnant women and children with chronic medical conditions are at an unacceptable risk of hospitalisation and death from influenza and COVID-19 infections. Pregnant women are 3 times more likely to die from COVID-19 and over 7 times more likely to be admitted to an intensive care unit (ICU) with influenza compared to non-pregnant women. Children with chronic disease are already compromised with a higher risk of hospitalisation from influenza and requirement for ICU management and long term disability following COVID-19.
Uptake of the recommended influenza vaccine among pregnant women and medically at risk children in Australia is only \~50%. Based on recent surveys, the predicted uptake of COVID-19 vaccine among both groups is also likely to be \~50%. These two groups preferentially receive care from medical specialists (obstetricians and paediatricians) and specialist nursing staff in hospitals, and are less likely to engage with primary care, the usual providers of immunisation.
The aim of this project is to develop a nudge (i. e. small changes in the environment that alter people's behaviour) and evaluate the effectiveness of the nudge intervention in improving the uptake of COVID and influenza vaccine by conducting four randomised control trials in.
* pregnant women. * medically at risk children.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 6 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-10-26
Primary completion: 2024-06-30
Study completion finish: 2024-12-31
Study type
HEALTH_SERVICES_RESEARCH
Phase
NA
Trial ID
NCT05613751
Intervention or treatment
BEHAVIORAL: Nudge
Conditions
- • COVID-19
- • Influenza
Find a site
Closest Location:
Flinders Medical Centre
Research sites nearby
Select from list below to view details:
Flinders Medical Centre
Bedford Park, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Pregnant women-COVID-19 vaccine RCT - intervention group
| BEHAVIORAL: Nudge
|
NO_INTERVENTION: Pregnant women-COVID-19 vaccine RCT - standard care group
| Not specified |
EXPERIMENTAL: Pregnant women-influenza vaccine RCT - intervention group
| BEHAVIORAL: Nudge
|
NO_INTERVENTION: Pregnant women-influenza vaccine RCT - standard care group
| Not specified |
EXPERIMENTAL: Medically at risk children-COVID-19 vaccine RCT - intervention group
| BEHAVIORAL: Nudge
|
NO_INTERVENTION: Medically at risk children-COVID-19 vaccine RCT - standard care group
| Not specified |
EXPERIMENTAL: Medically at risk children-influenza vaccine RCT - intervention group
| BEHAVIORAL: Nudge
|
NO_INTERVENTION: Medically at risk children-influenza vaccine RCT - standard care group
| Not specified |
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR). | The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one dose of influenza vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR). | From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks |
To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR) | The difference in proportion of medically as risk children in the intervention versus standard care (non-intervention) group receiving at least one dose of the seasonal influenza vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR). | Within 3 months after randomisation |
To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR). | The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one or more doses of a COVID-19 vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR). | From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks |
To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of a COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR) | The difference in proportion of medically at risk children receiving at least one dose of a COVID-19 vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR). | Within 3 months after randomisation |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Number of pregnant women who received COVID-19 or influenza vaccines, change from baseline to one month post-delivery, based on socio-demographic characteristics | Number of pregnant participants who received COVID-19 or influenza vaccines, change from baseline up to one month post-delivery, based on socio-demographic characteristics using the hospital records and Australian Immunisation Register (AIR). | From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks |
Number of medically at risk children who received COVID-19 or influenza vaccines, change from baseline up to three months post-randomisation, based on socio-demographic characteristics | Number of medically at risk pediatric participants who received COVID-19 or influenza vaccines, change from baseline up to three months post-randomisation, based on socio-demographic characteristics using the hospital records and Australian Immunisation Register (AIR). | From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months |
To assess timeliness of influenza/ COVID-19 vaccine uptake among pregnant women during the study period by determining the proportion of pregnant women who receive the influenza or COVID-19 vaccine by month throughout the study period. | Timeliness of influenza and COVID-19 vaccine uptake among pregnant women during the study period will be assessed by determining the difference in proportion of pregnant women who receive the COVID-19 or influenza vaccine by month throughout the study period using the vaccination status data recorded in the Australian Immunisation Register (AIR). | From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks |
To assess timeliness of influenza and COVID-19 vaccine uptake among medically at risk children during the study period by determining the proportion of medically at risk children who receive the COVID-19 or influenza vaccine by month. | Timeliness of influenza and COVID-19 vaccine uptake among medically at risk children during the study period by determining the difference in proportion of medically at risk children who receive the COVID-19 or influenza vaccine by month throughout the study period using the vaccination status data recorded in the Australian Immunisation Register (AIR). | From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months |
To estimate the cost-effectiveness of proven interventions compared to standard care in hospital settings | The incremental cost per additional person vaccinated will be assessed by comparing interventions to standard care in hospital settings. The cost per quality-adjusted life year (QALY) gained for influenza vaccination will be assessed. Implementation costs will be obtained from the study budget and costs related to research activities will be excluded. Estimated cost offsets to the health system associated with influenza related disease (e.g. hospitalisations and emergency visits) will be derived from the literature and calculated using cost weights for Australian Refined Diagnosis Related Groups (AR-DRGs). | From the date of randomisation until 46 weeks after randomisation |
To determine the difference in proportion of pregnant women in intervention versus standard care arm receiving one dose of the influenza/COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR). | The difference in proportion of pregnant women who receive one dose of influenza/COVID-19 vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR). | From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 week |
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