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Trial registered on ANZCTR


Registration number
ACTRN12608000302358
Ethics application status
Approved
Date submitted
11/06/2008
Date registered
17/06/2008
Date last updated
14/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Four week old infants in primary care receive precall letter from the general practice compared with the same age infants at practices with usual care to improve immunisation rates in young chlidren
Scientific title
Four week old infants in primary care receive precall letter from the general practice compared with the same age infants at practices with usual care to measure the subsequent immunisation coverage and timeliness rates
Secondary ID [1] 580 0
Nil
Universal Trial Number (UTN)
Trial acronym
Project ENGAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant immunisation series 3253 0
Condition category
Condition code
Public Health 3417 3417 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single precall letter sent to parents of infants when they are aged 4 weeks welcoming them and inviting their parents to bring them for a check-up and to start their immunisation series when aged six weeks. The precall letter will be sent out until 500 children have been precalled from the intervention practices
Intervention code [1] 2992 0
Other interventions
Comparator / control treatment
Usual care, which is generally recall letters sent at 6 weeks or later
Control group
Active

Outcomes
Primary outcome [1] 4312 0
Measure immunisation coverage at age 8 weeks to assess timeliness and coverage of the 6 week immunisation. The coverage will be measured using the National Immunisation Register (NIR) accessed through the Auckland district Health Board.
Timepoint [1] 4312 0
8 weeks
Secondary outcome [1] 7265 0
Measure immunisation coverage at age 14 weeks to assess timeliness and coverage of 3 month immunisation. The coverage will be measured using the National Immunisation Register (NIR) accessed through the Auckland district Health Board.
Timepoint [1] 7265 0
14 weeks
Secondary outcome [2] 7266 0
Measure coverage and timeliness for the primary course of infant immunisations (given at 6 weeks, 3 months and 5 months) at age 6 months. The coverage will be measured using the National Immunisation Register (NIR) accessed through the Auckland district Health Board.
Timepoint [2] 7266 0
6 months
Secondary outcome [3] 7267 0
Measure coverage and timeliness for the primary course of infant immunisations (given at 6 weeks, 3 months and 5 months) at age 6 months. The coverage will be measured using the National Immunisation Register (NIR) accessed through the Auckland district Health Board.
Timepoint [3] 7267 0
6 months

Eligibility
Key inclusion criteria
General practices in the Auckland District Health Board (ADHB) birth cohort of approximately 8000 newborn children recorded on the National Immunisation Register (NIR).

Sample Size
Approximately 1000 infants (500 in control and 500 in intervention arm) will be followed.
Minimum age
4 Weeks
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Practices which do not immunise children

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)
A computer generated randomisation sequence will be prepared by an independent researcher. A random sequence will be used to assign each practice to either the intervention or the control group. The number that determines whether each enrolled practice is assigned to the intervention or control group will be kept in sequentially numbered sealed envelopes. A person independent of the investigators will assign each sequentially enrolled practice to the matching sequentially labelled sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation sequence will be prepared by an independent researcher. A random sequence will be used to assign each practice to either the intervention or the control group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
8/01/2009
Date of last participant enrolment
Anticipated
Actual
30/04/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
1300
Recruitment outside Australia
Country [1] 1003 0
New Zealand
State/province [1] 1003 0

Funding & Sponsors
Funding source category [1] 3475 0
Government body
Name [1] 3475 0
NZ Health Research Council & Ministry of Health
Country [1] 3475 0
New Zealand
Primary sponsor type
Government body
Name
NZ Health Research Council
Address
PO Box 5541, Wellesley Street, Auckland
Country
New Zealand
Secondary sponsor category [1] 3117 0
Government body
Name [1] 3117 0
Ministry of Health
Address [1] 3117 0
PO Box 5013
WELLINGTON
Country [1] 3117 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5505 0
HRC Northern Ethics Committee
Ethics committee address [1] 5505 0
Private Bag 92-522, Wellesley St
Auckland
Ethics committee country [1] 5505 0
New Zealand
Date submitted for ethics approval [1] 5505 0
01/08/2008
Approval date [1] 5505 0
29/08/2008
Ethics approval number [1] 5505 0
NTX/08/08/072

Summary
Brief summary
In New Zealand, the infant immunisation programme is delivered in the general practice setting. There is wide variance in practice immunisation coverage. Recent research has identified key characteristics of general practice that are associated with higher immunisation coverage. One of these is the early formation of a close relationship with the child’s family/whanau. Delay in receipt of the first vaccine dose in the primary series is one of the strongest predictors of subsequent incomplete immunisation. It is hypothesised that an intervention which enables early enrolment of newborns into general practice registers and effective practice systems will improve the completion and timeliness of the primary immunisation series. This randomised trial will implement an improved practice system consisting of early enrolment, a timely parental resource and decision-making tool, early recall and extra practice nurse support to improve immunisation coverage and timeliness. Outcome measures will be coverage and timeliness at age 8 weeks, 14 weeks and 6 months of the primary immunisation series. Potential health gains are increased immunisation coverage and timeliness with an associated reduced incidence of vaccine preventable disease in New Zealand.
Trial website
Trial related presentations / publications
01/08/2011
GOODYEAR-SMITH F, PETOUSIS-HARRIS H, POOLE T, GRANT C, TURNER N. Early Connection: An intervention at the general practice level to improve immunisation coverage and timeliness in infants – a randomised controlled trial. Report to the Health Research Council and the New Zealand Ministry of Health, 42pp, 2011
GOODYEAR-SMITH F, GRANT C, POOLE T, PETOUSIS-HARRIS H, TURNER N, PERERA R, HARNDEN A. Early Connections: Effectiveness of a pre-call intervention to improve immunisation coverage and timeliness. Journal of Primary Health Care. 2012; 4(3):189-198.
15. Royal New Zealand College of General Practitioners Annual Conference. Early Connections: Improving immunisation coverage & timeliness. GOODYEAR-SMITH F, PETOUSIS-HARRIS H, T POOLE T, GRANT C, TURNER N, HARDNEN A, PERERA R. Auckland. Sep 2011
Improving immunisation coverage & timeliness. GOODYEAR-SMITH F, PETOUSIS-HARRIS H, T POOLE T, GRANT C, TURNER N. Rotorua. Aug 2011
Public notes

Contacts
Principal investigator
Name 28661 0
Prof Felicity Goodyear-Smith
Address 28661 0
Room 378, Building 730 School of Population Health
Tamaki Campus University of Auckland
261 Morrin Rd, Glen Innes
Auckland
1142
Country 28661 0
New Zealand
Phone 28661 0
+6499232357
Fax 28661 0
Email 28661 0
[email protected]
Contact person for public queries
Name 11818 0
Felicity Goodyear-Smith
Address 11818 0
Department of General Practice & Primary Health Care
University of Auckland
PB 92 019 Auckland
Country 11818 0
New Zealand
Phone 11818 0
64 9 373 7599
Fax 11818 0
64 9 373 7624
Email 11818 0
[email protected]
Contact person for scientific queries
Name 2746 0
Assoc Prof Felicity Goodyear-Smith
Address 2746 0
Department of General Practice & Primary Health Care
University of Auckland
PB 92 019 Auckland
Country 2746 0
New Zealand
Phone 2746 0
64 9 373 7599 82357
Fax 2746 0
64 373 7624
Email 2746 0
[email protected]

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