Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000049774
Ethics application status
Not yet submitted
Date submitted
10/01/2013
Date registered
15/01/2013
Date last updated
4/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
“Vaccinate the child, vaccinate the parent” – Evaluating simple strategies to improve awareness and uptake of measles vaccination among adults in South Eastern Sydney (SES).
Scientific title
Among General Practices, does a simple promotion strategy to encourage practitioners to screen parents for history of MMR vaccination whilst they attend the practice to have their young children vaccinated, result in an increase in the number of adults vaccinated against MMR, compared to existing ad-hoc practices?
Secondary ID [1] 281705 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Measles 287944 0
Mumps 287945 0
Rubella 287946 0
Condition category
Condition code
Public Health 288327 288327 0 0
Health promotion/education
Infection 288328 288328 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the promotion to participating practices of screening of parents for practice documentation or history of MMR vaccination whilst they are in the practice to have their young children vaccinated.

For practices who consent to participate, an appointment will be arranged between practice staff and study staff to thoroughly describe the program and provide the study materials.

The following resources will be included in the study materials;
Study protocol
Information and consent forms for participating general practices/nurses
Information and consent forms for participating parents, this will include the Priorix product and consumer information
Advertising material including a poster and leaflets, vaccine fridge prompts.
Promotional reminders for recruited practices
Pre-vaccination screening checklist
Visual prompts (poster and leaflets) will be available in the waiting room to promote participation.
Fridge magnets will be placed on the vaccine fridge to prompt providers

The intervention will last for 6 months
The promotional reminders will be a contact presence throughout teh waiting room and on the vaccine fridge for the duration of the intervention.
Intervention code [1] 286203 0
Behaviour
Intervention code [2] 286204 0
Prevention
Comparator / control treatment
MMR vaccines distributed in the 12 months prior to the study will be the historical comparison measure.

The information on vaccine distribution will be obtained from the NSW State Vaccine Centre
Control group
Historical

Outcomes
Primary outcome [1] 288498 0
The number of doses of Priorix ordered/administered to adults pre and post intervention.

A simple vaccine use running sheet will be located on or near the vaccine fridge and will be completed by the vaccine service provider for each dose of Priorix vaccine administered. The table has 4 columns; 1. Date, 2. Adult (over 18 years), 3. Child (less than 18 years) and 4. Doses drawn up but not given/wasted.
Timepoint [1] 288498 0
Measure outcomes 6 months after commencement of intervention.
Secondary outcome [1] 300326 0
Vaccine providers’ attitudes and practices towards adult MMR vaccination and description of parents compliance and non-compliance to MMR vaccination

A practice survey is completed pre and post intervention to measure participating providers practice. A brief parent survey with a 3 part question will be completed by the immunisation service provider when they are offering Priorix vaccination to the adult.
Timepoint [1] 300326 0
Measure outcomes 6 months after commencement of intervention.

Eligibility
Key inclusion criteria
Inclusion criteria for general practices (“primary participants”): all general practices in South Eastern Sydney Local Health District with a vaccine account number (from the State Vaccine Centre)

Inclusion criteria for participants indirectly included in the research (“secondary participants”): Adults born in or after 1966 who attend the practice with a child for scheduled childhood vaccinations will be approached by the GP or practice nurse to participate.
Minimum age
18 Years
Maximum age
47 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for general practices (“primary participants”): general practices in South Eastern Sydney Local Health District that do not have a vaccine account number.

Exclusion criteria for participants indirectly included in the research (“secondary participants”):
1. Adults born prior to 1966 who attend the practice with a child for routine childhood vaccinations.
2. Adults unaccompanied by a child presenting for treatment or vaccination.
3. Participants are not required to be immunised to be included in the study. Any participants who are pregnant, immunocompromised, symptomatic HIV positive, immunocompromised, allergic to any components in the vaccine will not be vaccinated, but a questionnaire will still be completed and the medical practice paid for its return. The participant’s information form will contain information on the contraindications for vaccination. The vaccine provider will also assess for contraindications as part of the NHMRC recommended routine pre vaccination assessment for all vaccinations (page 16, Australian Immunisation Handbook)
4. Adults declining consent. Note, adult born on or after 1966 that decline participation in the study can still receive Priorix vaccine if they are not immune, have an uncertain or no vaccination history.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment procedure for general practices (“primary participants”):
Initial telephone contact will be made with a random sample of 106 practices to obtain consent. The principal researcher will contact the principal provider and other relevant practice staff to promote the campaign and obtain consent. The practices will be randomly selected from provider/practice details supplied by The NSW State Vaccine Centre. Following the provision of telephone consent, an appointment will be arranged between practice staff and study staff to thoroughly describe the program and provide the study materials. The researchers will continue to recruit practices until a minimum of 53 practices provide consent to be enrolled in the study. We took a conservative response rate of 50% based on a literature review that has previously been undertaken which suggested a mean participation rate of 54%. Because of the visual nature of this study (the use of posters and reminders), general practices will not be blinded to their allocated group.

Enrolment procedure for participants indirectly included in the research (“secondary participants”):
The secondary participants are adults aged 18-46 years who attend the medical practice with their child for childhood immunisations. The vaccine provider will recruit these adults into the study. For every child who attends a participating general practice for any vaccination, the parent will be given the participant information sheet and consent form, a brief explanation of the study will be given, the parent will be asked to read the information and sign the consent form. The GP/nurse will screen the adult/s for contraindications for vaccination and determine their vaccination history by asking if they recall previous vaccination or have evidence of vaccination in their patient files. Based on the recommendations in the Australian Immunisation Handbook, 1-2 doses of Priorix will be offered to those without evidence of 2 doses of vaccine or an uncertain history. The GP/nurse will complete a 3 question survey on the first occasion for every adult who is screened. These questions are;
1.Is the adult receiving the MMR vaccine? Yes/No
a.If yes is this a travel-specific vaccination or a general update?
b.If no, why? (options – already received 2 doses, immune, decline)
c.If not being vaccinated today but are considering returning for vaccination please supply a contact name and phone number/email for a follow up in 1 month.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The primary participants are the medical practices. The original database of practices comes from the State Vaccine Centre, who has given the researchers a list of all providers in South Eastern Sydney Local Health District with a vaccine account number. Practices must have a vaccine account number to receive state funded vaccines. From this list of 401 medical practices, the investigators will take a random sample of 106 practices. Randomisation of practices will be based on their vaccine account number using random allocation software. The researchers will attempt to recruit 53 of these 106 randomly selected practices. Changes in the number of MMR (Priorix) ordered/administered for adults by these 53 practices following the intervention will be compared to doses ordered prior to the intervention (pre-post intervention study design).
The secondary participants are adults aged 18-46 years who attend the medical practice with their child for childhood immunisations. The vaccine provider will recruit these adults into the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study will be evaluated using 3 methods; data on vaccine doses administered, pre and post interviews and
information collected in the survey completed each time a parent is screened.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
4/02/2013
Actual
Date of last participant enrolment
Anticipated
5/08/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
53
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286492 0
Commercial sector/Industry
Name [1] 286492 0
GlaxoSmithKline Australia
Country [1] 286492 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline pharmaceuticals
Address
Level 4, 436 Johnston Street, Abbotsford, Victoria, 3067.
PO Box 18095, Melbourne, Victoria, 8003.
Country
Australia
Secondary sponsor category [1] 285282 0
Government body
Name [1] 285282 0
South Eastern Sydney Local Health District Public Health Unit
Address [1] 285282 0
Locked Bag 88, Randwick NSW 2031
Country [1] 285282 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288570 0
University of NSW HREC
Ethics committee address [1] 288570 0
University of NSW,
High Street Kensington NSW 2052
Ethics committee country [1] 288570 0
Australia
Date submitted for ethics approval [1] 288570 0
02/07/2012
Approval date [1] 288570 0
Ethics approval number [1] 288570 0
HC12376

Summary
Brief summary
We have submitted an application the the University of NSW HREC who have requested we proceed with a clinical trial application.

The study is being conducted to trial simple strategies to improve the uptake of measles immunisation in adults born in or after 1966 who may not be fully vaccinated and at risk of being infected with measles. The study is a pre-post intervention design. A random sample of 53 general practices will be recruited to participate. During the intervention, the general practices will be given resources to promote vaccination of adults against measles at the same time as these parents attend the medical practice to have their children vaccinated. The campaign is called "Vaccinate the child, vaccinate the parent".
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36554 0
Prof Mark Julian Ferson
Address 36554 0
Hut U, Building 23,
Easy Street,
Prince of Wales Hospital Campus
Randwick NSW 2031
Country 36554 0
Australia
Phone 36554 0
+61 02 93828233
Fax 36554 0
+61 02 93828370
Email 36554 0
[email protected]
Contact person for public queries
Name 36555 0
Mrs Karen Orr
Address 36555 0
Hut U, Building 23,
Easy Street,
Prince of Wales Hospital Campus
Randwick NSW 2031
Country 36555 0
Australia
Phone 36555 0
+61 02 93828333
Fax 36555 0
+61 02 93828334
Email 36555 0
[email protected]
Contact person for scientific queries
Name 36556 0
Mrs Karen Orr
Address 36556 0
Hut U, Building 23,
Easy Street,
Prince of Wales Hospital Campus
Randwick NSW 2031
Country 36556 0
Australia
Phone 36556 0
+61 02 93828333
Fax 36556 0
+61 02 93828334
Email 36556 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.