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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women-COVID-19 vaccine RCT - intervention group | Experimental | Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine |
|
| Pregnant women-COVID-19 vaccine RCT - standard care group | No Intervention | Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine. They will receive normal care at the hospital. | |
| Pregnant women-influenza vaccine RCT - intervention group | Experimental | Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine |
|
| Pregnant women-influenza vaccine RCT - standard care group | No Intervention | Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine. They will receive normal care at the hospital. | |
| Medically at risk children-COVID-19 vaccine RCT - intervention group | Experimental | Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nudge | Behavioral | Three text messages that are sent four weeks apart reminding to obtain the vaccines |
|
| Measure | Description | 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) |
| Measure | Description | 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). |
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Inclusion Criteria:
Exclusion Criteria:
COVID-19 pregnant women RCT: Pregnant women have contraindications to COVID-19 vaccines and already randomised to influenza RCT.
Influenza pregnant women RCT: Pregnant women have contraindications to Influenza vaccines and already randomised to COVID-19 RCT.
COVID-19 medically at risk children RCT:
Influenza medically at risk children RCT:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's and Children's Hospital | Recruiting | Adelaide | South Australia | 5006 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38367966 | Derived | Wang B, Andraweera P, Danchin M, Blyth CC, Vlaev I, Ong J, Dodd JM, Couper J, Sullivan TR, Karnon J, Spurrier N, Cusack M, Mordaunt D, Simatos D, Dekker G, Carlson S, Tuckerman J, Wood N, Whop LJ, Marshall H. Nudging towards COVID-19 and influenza vaccination uptake in medically at-risk children: EPIC study protocol of randomised controlled trials in Australian paediatric outpatient clinics. BMJ Open. 2024 Feb 17;14(2):e076194. doi: 10.1136/bmjopen-2023-076194. | |
| 37438776 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Four multi-centre, parallel group, superiority, randomized control trials (with 1:1 allocation) of nudge interventions to improve influenza and COVID-19 vaccine uptake among pregnant women and medically at risk children. Each RCT will enroll 1038 participants (n = 519 each in intervention and control groups), with a total of 4154 participants in the four RCTs:
pregnant women's RCTs
medically at-risk children's RCTs
There are eight arms in total for four RCTs.
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Blinding is considered desirable; however, it will depend on the type of nudge and will be determined after the nudge is developed. Endpoint measurements will involve low level contact of study staff, however when contact is required (such as AIR/ confirmation of influenza/COVID-19 vaccine receipt etc), this will be carried out by trial staff shielded from information that might reveal trial group assignment. The study statistician undertaking the analysis and study investigators will remain blinded to trial intervention assignment.
|
| Medically at risk children-COVID-19 vaccine RCT - standard care group | No Intervention | Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine. They will receive normal care at the hospital. |
| Medically at risk children-influenza vaccine RCT - intervention group | Experimental | Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine |
|
| Medically at risk children-influenza vaccine RCT - standard care group | No Intervention | Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine. They will receive normal care at the hospital. |
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 |
| 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 |
| Flinders Medical Centre | Recruiting | Bedford Park | South Australia | 5042 | Australia |
|
| Lyell McEwin Hospital | Recruiting | Elizabeth Vale | South Australia | 5112 | Australia |
|
| Mercy Hospital For Women | Recruiting | Heidelberg | Victoria | 3084 | Australia |
|
| The Royal Children's Hospital | Recruiting | Parkville | Victoria | 3052 | Australia |
|
| Perth Children's Hospital | Recruiting | Nedlands | Western Australia | 6009 | Australia |
|
| King Edward Memorial Hospital | Not yet recruiting | Subiaco | Western Australia | 6008 | Australia |
|
| Derived |
| Andraweera PH, Wang B, Danchin M, Blyth C, Vlaev I, Ong J, Dodd J, Couper J, Sullivan TR, Karnon J, Spurrier N, Cusack M, Mordaunt D, Simatos D, Dekker G, Carlson S, Tuckerman J, Wood N, Whop L, Marshall HS. 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. Trials. 2023 Jul 12;24(1):454. doi: 10.1186/s13063-023-07485-9. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |