Flutext 4 U - The effect of provider and parent strategies on influenza vaccination rates in children and adolescents with special risk medical conditions.
- Conditions
- InfluenzaPublic Health - Health service researchInfection - Other infectious diseases
- Registration Number
- ACTRN12621000463875
- Lead Sponsor
- Women's and Children's Health Network
- Brief Summary
Parents (of children aged 6 months to 18 years with Special Risk Medical Conditions (SRMC)) were enrolled from April 15th to August 13th, 2021, and randomised (1:1 ratio) to standard care or intervention, stratified by age-group (<5, 5-14, >14- <18 years). The primary outcome was influenza vaccination, confirmed by the AIR. There were a total of 18 sub-specialty doctors involved in the implementation of the study from one of six specialty departments at the Women's and Children's Hospital (diabetes/endocrine, neurology, respiratory, rheumatology, cardiology and gastroenterology). Over the intervention period (April to end August), a total of 2831 children were screened for a medical condition recognised by the Australian Immunisation Handbook as being eligible for free influenza vaccination regardless of age. Of these children, 619 were randomised to the two treatment groups and 2212 were ineligible according to protocol exclusions. A total of 600 participants were included in the statistical analysis (standard=302; mean age 11.4 years; intervention=298; mean age 11.5 years. Flutext-4U intervention participants had higher influenza vaccine receipt (38.6%), compared to participants receiving standard care. In this study, among children and adolescents with SRMC at a paediatric tertiary hospital, a multicomponent intervention that included a parent SMS message was superior to standard care and resulted in more timely influenza vaccine receipt.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 619
Sub-specialists & GPs:
•All medical practitioners working under the diabetes, neurology, respiratory, gastroenterology, rheumatology, cardiology sub-specialties at the WCH and the child’s referring GP.
Each participant must meet all of the following criteria to be enrolled in this trial:
•Parent of a child/adolescent with a special risk medical condition putting them at increased risk of serious influenza complications such as: heart disease or chronic lung conditions; severe asthma (those who need frequent GP visits or multiple medications); nervous system diseases, which may affect breathing, e.g. Multiple Sclerosis; diabetes or kidney disease; lowered immunity, either due to disease or treatment, e.g. cancer or rheumatoid arthritis treatment; certain blood disorders; and children taking aspirin long term.
•Have a WCH outpatient appointment with sub- specialities: diabetes, neurology, respiratory, gastroenterology, rheumatology or cardiology between April and the end of July 2021.
Patients meeting any of the following criteria will be excluded from the trial:
•Previous receipt of influenza vaccine in 2021, prior to trial commencement (defined as receipt on AIR).
•Younger sibling of another trial participant (to ensure parents are not randomised twice).
•No listed mobile phone number for parent / guardian on WCH patient registration.
•New patients without a confirmed special risk medical condition diagnosis.
•Children or adolescents with a diagnosis of Cystic Fibrosis. These children already receive additional vaccine delivery support and influenza vaccine messaging within the WCH environment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of medically at-risk children who receive one or more doses of influenza vaccine, assessed using the Australian Immunisation Register (AIR) records and parental report via SMS. These two measures (1) AIR records and (2) parental reporting of vaccine uptake via SMS to the study team will be combined as a composite primary outcome.[At the end of the 4 month intervention period (April to July 2021).]
- Secondary Outcome Measures
Name Time Method Impact of the trial interventions on vaccination rates of medically at-risk children aged 6 months to 18 years assessed by data obtained from the Australian Immunisation Register and parental report via SMS.[At the end of the 4 month intervention period (April to July 2021).];Parental acceptability of the intervention will be assessed using an SMS survey, specifically designed for the study and distributed via Message Media (bulk SMS software package).<br>[At the end of the 4 month intervention period (April to July 2021).]