ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000463875

Ethics application status

Approved

Date submitted

29/01/2021

Date registered

20/04/2021

Date last updated

2/05/2022

Date data sharing statement initially provided

20/04/2021

Date results information initially provided

2/05/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

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

Scientific title

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.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Influenza

Condition category

Condition code

Public Health

Health service research

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

Trial Arm 1 (standard group): Participants randomised to trial arm 1 will receive only the tertiary practice / provider-level interventions during the implementation period of the study (April to July 2021); comprising of:

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/Endocrinology, 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: 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.

Control group

Active

Outcomes

Primary outcome [1]

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.

Timepoint [1]

At the end of the 4 month intervention period (April to July 2021).

Secondary outcome [1]

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.

Timepoint [1]

At the end of the 4 month intervention period (April to July 2021).

Secondary outcome [2]

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).

Timepoint [2]

At the end of the 4 month intervention period (April to July 2021).

Eligibility

Key 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.

Minimum age

6 Months

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key 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.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Parents (of children/adolescents) will be randomised to either the standard trial arm or intervention trial arm in a 1:1 ratio. A statistician not directly involved in the analysis of the trial results will prepare the randomisation schedule. The randomisation schedule is shared with WCH ICT Staff who are responsible for randomly allocating eligible participants to the schedule.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Sequence generation will be done by the independent statistician using a secure web-based randomisation service; the randomisation schedule will be prepared by an independent statistician using randomly permuted blocks, stratified by age-group (<5, 5-14, >14 years).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment

Factorial

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

We plan to enrol 540 parents of children / adolescents medically at-risk receiving tertiary care at the WCH. In order to have 80% power to detect an increase in the percentage of children vaccinated from 40% in the standard care arm to 52% in the trial arm containing all Flutext-4U components (30% relative increase; absolute increase 12%), a sample size of 270 children per group is required (two-tailed alpha = 0.05). Previous studies have shown a 30% to 70% relative increase following other immunisation interventions.
A 30% relative increase in the percentage vaccinated would be considered clinically meaningful. The world Health Organisation has called for an optimistic target of 75% coverage of influenza vaccine in medically at-risk children. We believe a realistic target for this project and confirmation of an effective strategy would be an absolute increase of at least 10% (relative increase 30%).

Population analyses will be conducted following the intention-to-treat (ITT) principle, where outcome data are available. Participants will be compared according to the group to which they were randomly allocated, regardless of participants' compliance, crossover to other treatments or withdrawal from the trial. Thereby preserving the prognostic balance in the trial arms achieved by randomisation.

For the primary outcome, the number and proportion of participants receiving influenza vaccination in each group will be presented. The proportion vaccinated (primary outcome) will be compared between randomised groups using logistic regression, with adjustment made for variables used to stratify the randomisation. The effect of treatment will be described using an odds ratio with a 95% confidence interval. Subgroup analysis will examine the effect of medical risk condition, age group (<5, 5-14, >14 years) and geographical location (residential) on the primary outcome. Secondary analyses will be performed using logistic regression for binary outcomes and negative binomial regression for count outcomes. In all analyses, a two-sided p-value < 0.05 will be used to indicate statistical significance.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

15/04/2021

Date of last participant enrolment

Anticipated

30/07/2021

Actual

13/08/2021

Date of last data collection

Anticipated

30/11/2021

Actual

17/12/2021

Sample size

Target

540

Accrual to date

Final

619

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment postcode(s) [1]

5006 - North Adelaide

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Women's and Children's Hospital Foundation

Address [1]

Ground Floor
55 King William Road
North Adelaide,
South Australia 5006

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Women's and Children's Health Network

Address

Women's and Children's Hospital
Kermode Street,
North Adelaide
South Australia 5006

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Adelaide

Address [1]

Department of Paediatrics
Vaccinology and Immunology Research Trials Unit
Level 2, Women's and Children's Hospital
Kermode Street,
North Adelaide
South Australia 5006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network

Ethics committee address [1]

Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/02/2020

Approval date [1]

22/05/2020

Ethics approval number [1]

HREC/20/WCHN/5

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Helen Marshall

Address

Department of Paediatrics
Vaccinology and Immunology Research Trials Unit
Women's and Children's Hospital
Kermode Street
North Adelaide
South Australia 5006

Country

Australia

Phone

+61 08 81618115

Fax

+61 08 8161 7031

[email protected]

Contact person for public queries

Name

Mrs Kelly Harper

Address

Department of Paediatrics
Vaccinology and Immunology Research Trials Unit
Women's and Children's Hospital
Kermode Street
North Adelaide
South Australia 5006

Country

Australia

Phone

+61 08 8161 6328

Fax

+61 08 8161 7031

[email protected]

Contact person for scientific queries

Name

Dr Jane Tuckerman

Address

Department of Paediatrics
Vaccinology and Immunology Research Trials Unit
Women's and Children's Hospital
Kermode Street
North Adelaide
South Australia 5006

Country

Australia

Phone

+61 08 8161 6328

Fax

+61 08 8161 7031

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Only published results of de-identified participant data may be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept WCHN conditions for access.

When will data be available (start and end dates)?

Beginning 12 months following analysis and article publication. All data will be retained for a period of 15 years before being destroyed, in accordance with WCH policies for clinical study data.

Available to whom?

Individual participant data will only be available to researchers from recognised research institutions whose proposed use of the data has been ethically reviewed and approved by an independent human reserach ethics committee and who accept the WCHN HREC conditions for access.

Available for what types of analyses?

Flutext-4U will be the first study to examine influenza vaccination text messaging in the context of children who are medically at-risk and has a high probability of making a significant contribution to the field. The individual participant data will be available for analysis to achieve the aims in the approved proposal.

How or where can data be obtained?

Data will be retained and archived in a secure WCHN, Department of Paediatrics network drive which will be managed by the Principal Investigator. To obtain access to the data, a written proposal should be directed to the Principal Investigator, Prof Helen Marshall at the Women's and Children's Hospital, Vaccinology and Immunology Research Trials Unit via email [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10393	Ethical approval					381319-(Uploaded-19-04-2021-16-07-58)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			381319-(Uploaded-29-04-2022-15-56-56)-Basic results summary.docx
Plain language summary	No		Parents (of children aged 6 months to 18 years wit... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Using provider-parent strategies to improve influenza vaccination in children and adolescents with special risk medical conditions: a randomised controlled trial protocol.	2022	https://dx.doi.org/10.1136/bmjopen-2021-053838
Embase	Short Message Service Reminder Nudge for Parents and Influenza Vaccination Uptake in Children and Adolescents with Special Risk Medical Conditions: The Flutext-4U Randomized Clinical Trial.	2023	https://dx.doi.org/10.1001/jamapediatrics.2022.6145

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically