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Flutext 4 U - The effect of provider and parent strategies on influenza vaccination rates in children and adolescents with special risk medical conditions.

The effect of a multi-component intervention targeting influenza vaccination uptake in children and adolescents with special risk medical conditions at the provider and parent levels: a randomised controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000463875
Enrollment
619
Registered
2021-04-20
Start date
2021-04-15
Completion date
2021-08-13
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to see how well a multi-component intervention can increase influenza vaccination for children and adolescents who are medically at-risk from severe influenza disease. The Flutext-4U intervention components at the tertiary, primary care and parent levels e.g. SMS reminders for parents; reminders for WCH specialists to discuss and/or deliver vaccines; and communication from the tertiary provider to the child's GP about influenza vaccination. Study participants are WCH specialists, GPs and parents. This single-site trial will provide the tertiary-level intervention components to a group of parents (trial arm#1), while another group will additionally receive primary care level and parent level intervention components (trial arm #2). Parents (of children identified as medically at risk of serious influenza disease) will be randomly allocated to either group. The study will test the intervention by comparing both groups and will use immunisation records to assess vaccine uptake. At the end of the intervention period, the study will also use an SMS survey to assess vaccine uptake; acceptability of the SMS reminders to get their child vaccinated; whether they would want to receive SMS reminders in the future; their most convenient place to receive the vaccine and what prompted vaccine receipt.

Interventions

Flutext-4U will be the first study to examine influenza vaccination text messaging in the context of children who are medically at-risk of severe influenza complications. It has a high probability of making a significant contribution to the field. Flutext-4U addresses a major gap in our understanding of how text messaging may serve as an intermedium to mediate coverage. This research will support changes to the way preventative care for high-risk children is managed and meet the target group’s e

Flutext-4U will be the first study to examine influenza vaccination text messaging in the context of children who are medically at-risk of severe influenza complications. It has a high probability of making a significant contribution to the field. Flutext-4U addresses a major gap in our understanding of how text messaging may serve as an intermedium to mediate coverage. This research will support changes to the way preventative care for high-risk children is managed and meet the target group’s expectations of care. Increasing coverage in one of our most vulnerable populations will have a significant impact on influenza and all-cause respiratory hospitalisations. Any effects in coverage will assist other Australian jurisdictions. The trial is a randomised controlled trial (RCT) with two parallel arms, whereby participants are randomly allocated to either trial arm 1 (standard care group) or trial arm 2 (intervention group). Participants randomised to trial arm 2 will receive all specific interventions being studied. Trial Arm 1 is the comparator treatment receiving only tertiary practice / provider-level interventions. Trial Arm 2 (intervention group): Participants randomised to trial arm 2 will receive all of the Flutext-4U intervention components being studied during the implementation period of the study (April to July 2021): 1. Tertiary Practice / Provider-level interventions: Medical case note reminder prompts in the form of stickers on the front and bookmarks inserted into the clinical notes section of case notes. Participating clinicians from the departments of Respiratory, Cardiology, Diabetes, Rheumatology, Neurology and Gastroenterology will be responsible for confirming patients with a special risk medical condition and eligible for free influenza vaccination under the Australian Government Funded Annual Influenza Program and attending a hospital outpatient appointment between April and July 2021. The case note reminder prompts will be administered by the study coordinator and placed in the case notes of identified patients of participating clinicians (from the departments listed above) to facilitate vaccine recommendation for their patients identified as having a special risk medical condition and eligible for a free flu vaccine regardless of their age. 2. Ensuring vaccine availability and ease of access at the WCH (standard care): the study coordinator has engaged the Immunisation Nurses at the WCH Immunisation Clinic on level one (drop in centre) and the Vaccinology and Immunology Research Trials Unit Nurses to work together and provide support for the potential increase in demand to avoid having to turn people away or make them wait long periods of time. Availability of the vaccine will be monitored by the WCH Immunisation Nurses who will inform the study coordinator of anticipated arrival of the vaccine on site, ready for roll out and for the trial intervention period to begin. They will also monitor the availability of the vaccine throughout the trial intervention period to ensure stock is available. 3. Primary Care Provider-level interventions: one hard copy letter to communicate with the child’s treating (referring) GP advising them that the child is identified as having a special risk medical condition and is at an increased risk of serious influenza complications and seeking their assistance as part of the child’s treating team to improve influenza vaccine uptake. Letters will be sent once only by the study coordinator with help from the WCH ICT Applications staff to identify the GPs. Vaccination uptake among the trial population will be assessed on the Australian Immunisation Register (AIR) with the place of vaccine administration being included in the evaluation. A survey will also be sent to parents at the end of the trial intervention period to ask what prompted their decision to get the vaccine this year with 'GP advice' being a response option. 4. Parent-level interventions: Three SMS reminders (two-weeks apart, sent between April and the end of July 2021. Parental SMS text message reminders will be sent in a non-directive educational approach automatically to the child’s parent (on behalf of the WCH) advising them that their child/adolescent is eligible for funded influenza and where they can receive it. Text messages will cease once the child is immunised. Text messages will comprise: i) the influenza vaccination message reminder text, ii) an option to reply, if the vaccine has been received and iii) an influenza vaccine decision making question. As text messaging incurs a small cost it is important to determine whether parent SMS messaging achieves a clinically relevant increase in uptake or if other tertiary and primary provider based initiatives are more worthy of allocating resources.

Sponsors

Women's and Children's Health Network
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026