Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001155189
Ethics application status
Approved
Date submitted
2/08/2019
Date registered
19/08/2019
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
He Korowai Manaaki Hawkes Bay: A Research Project of Pregnant Women to Test Whether Extra Free GP Appointments and a Way of Better Connecting Support Services Helps to Keep Infants Healthy.
Scientific title
He Korowai Manaaki Hawkes Bay: A cluster randomised clinical trial of primary care practices testing an augmented maternity care pathway to improve infant health outcomes.
Secondary ID [1] 298293 0
Health Research Council Funding 16/444
HDEC 17/STH/136 - NZ/1/5CCD010
Universal Trial Number (UTN)
U1111-1233-8124
Trial acronym
HKM-RCT
Linked study record
ACTRN12618000071224 was the first phase of the He Korowai Manaaki project. Beginning with an iwi-based model, learning whether this intervention would be more applicable for Maori communities (Phase 1 - ACTRN12618000071224), has informed Phase 2 (this application), the cluster randomised control trial seeking to enable system change to reduce disparities.

Health condition
Health condition(s) or problem(s) studied:
Infant health 313141 0
Condition category
Condition code
Reproductive Health and Childbirth 311617 311617 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating in the study involves primary care practice groups being informed about the study and consenting to take part. For those randomized to the intervention arm of the RCT, primary care practice providers will be trained to carry out the augmented best practice maternity-care pathway to any pregnant woman seeking the provider’s care services during the study period through to the baby being aged 6 weeks.

An advanced form called Pregnancy Wraparound Care (PWC) has been designed to support the appointments with pregnant women and uploaded to the computer systems of the four intervention primary care practices involved in the study. It supports referrals to allied services and prompts best practice with assessment prompts, health screening prompts, education resources, recall suggestions and connections for a wraparound service.

Intervention primary care practices are offered training and education refreshers sessions which cover utilization of the advanced form and education around the wraparound care pathway through lectures and Power Point presentations. The first 1 hour session takes place just prior to the intervention pathway commencing followed by two more 1-2 hour sessions over the following four months. These are presented by a team including the university researcher, project manager and relevant specialist practitioners (e.g. obstetricians). Additional sessions are available for new primary care staff at the request of each practice.

During the intervention period clinicians will provide added services for pregnant women. Additional to standard maternity care the pregnant woman in this intervention pathway will be offered:

1. First Touch extended antenatal appointment and Whanau focus needs assessment - face to face appointment with primary care provider - 30 to 40 minute appointment
2. Follow-up appointment to consider test results (ordered at First Touch) and follow on from discussions and referrals made from the Whanau focus needs assessment - face to face appointment with same practitioner that First Touch was undertaken by - 20 minute appointment
3. 3rd trimester GP visit - discussion of contraception planning, possible vaccination scheduling (flu and pertussis) if not received by this time, maternal wellness (including mental health) planning for delivery and infant care following the birth and General Practice care for the infant (midwife welcome to attend) - 20 to 30 minute appointment
4. 6-week postnatal GP visit - contraception delivery if not yet received and wanted by the woman, maternal wellness (including mental health) - 20 to 30 minute appointment

First Touch is an extended first antenatal appointment which includes a whanau focus needs assessment covering oral health, transport, support, housing, finances, vaccinations and education. Identified issues will be addressed by connecting the woman and whanau to existing services and support through this pathway. The pregnant woman will be booked with a midwife at this appointment.

At the Follow-Up appointment - undertaken by the same practitioner group that met the woman at First Touch, results from tests ordered at First Touch will be reviewed and discussed, and a follow-on conversation from discussions and referrals made from the Whanau focus needs assessment will take place - 20 minute appointment

At the 3rd Trimester GP appointment (midwife may also attend) discussion points from First Touch will be revisited, condition of mum and baby updated and looking ahead, advice given about delivery and baby's first few weeks. Education and information about early childhood education (ECE), breastfeeding, immunisations, oral health, safe sleep and contraception requirements will also be shared and planned. Maternal vaccinations will be available.

A further appointment to the GP will be arranged for when the baby is 6 weeks of age open to the mother, baby and whanau. This visit will include the baby's 6 week child checks plus discussion of maternal factors such as the planned contraception and any support or navigation required from the whanau focus in pregnancy.

Any unmet needs will be documented by the primary care providers.

Intervention adherence will not be assessed or collected by the individual practitioners - the individual care centre may audit this themselves if warranted
Intervention code [1] 315136 0
Prevention
Comparator / control treatment
The comparative group is the primary care practices randomly assigned to the control arm of the RCT. Pregnant women enrolled with and / or seen in these control practices during the intervention period will receive usual care and are the comparator.

Usual care for pregnant woman attending control practices means that any appointment held with primary care during or just following pregnancy would not be supported by a pregnancy wraparound program (the intervention), with four free primary care-held appointments, aided by an advanced form prompting evidence-based care and referrals to allied services (e.g. driving licensing program, healthy housing program).

Usual care does not provide a free follow-up appointment held with primary care.

Usual care does not provide a free third trimester appointment held with primary care.

Usual care provides a 6-week postnatal GP infant appointment. Usual care does not provide a 6-week postnatal GP maternity visit.

Usual care does not provide additional support with transport to pregnancy-related appointments nor provides options of free contraception.
Control group
Active

Outcomes
Primary outcome [1] 320881 0
To compare the number of infant hospitalisations for intervention and control cohorts
Timepoint [1] 320881 0
At one year of age for the delivered infant.
Outcomes will be assessed by the review of outcome data sourced by Ministry of Health (NZ) through the National Minimum Dataset's collection of public and private hospital discharge information.
Primary outcome [2] 320882 0
To compare the number of timely vacciations of infant for intervention and control cohorts.
Timepoint [2] 320882 0
Within one month of scheduled timing at 6 weeks, 3 months and 5 months
Outcomes will be assessed by review of outcome data sourced by Ministry of Health (NZ) through the National Immunisation Register's collection of immunization details of children in New Zealand.
Secondary outcome [1] 373234 0
To compare pre and post natal smoking status for intervention and control cohorts determined by data entry by maternity care providers
Timepoint [1] 373234 0
Smoking status and smoking quantity is assessed by a practitioner at allocation (first lead maternity care registration and booking) and at 2 weeks post-delivery (L= less than 10 cigarettes per day, M = 10-20 cigarettes per day, H = more than 20 cigarettes per day). These secondary outcomes will be assessed by review of outcome data sourced by Ministry of Health (NZ) through the National Maternity Collection (MAT database) which provides information about selected publicly funded maternity services up to 9 months before and 3 months after a birth.
Secondary outcome [2] 373236 0
To compare timely attendances (within 1 month of scheduled appointments) at Well Child Tamariki Ora infant checks for intervention and control cohorts.
Timepoint [2] 373236 0
At 8-10 weeks, 3-4 months, 5-7- months, 9-12 months, 15-18 months infant checks.
Timely attendance to the scheduled appointments will be assessed by review of appointment attendance and date of appointment sourced by Ministry of Health (MOH) (NZ) through The Well Child/Tamariki Ora data that is provided to the MOH.
Secondary outcome [3] 373237 0
To compare the obstetric outcomes (Caesarean section) for intervention and control cohorts.
Timepoint [3] 373237 0
Obstetric outcome will be assessed by review of outcome data sourced by Ministry of Health (NZ) through the National Maternity Collection (MAT database) which provides information about selected publicly funded maternity services up to 3 months after a birth.
Secondary outcome [4] 373239 0
To compare the gestational age at delivery for intervention and control cohorts.
Timepoint [4] 373239 0
Gestation at delivery will be assessed by review of outcome data sourced by Ministry of Health (NZ) through The National Minimum Dataset's collection of public and private hospital discharge information.
Secondary outcome [5] 373240 0
To compare infant registration to oral health services for intervention and control cohorts at 2 years of age.
Timepoint [5] 373240 0
The number of infant's registered to oral health services will be assessed by review of outcome data sourced by Ministry of Health (NZ) at 2 years of age.
Secondary outcome [6] 373241 0
To compare Early Childhood Education (ECE) / Te Kohanga Reo enrolment for intervention and control cohorts at 2 years of age.
Timepoint [6] 373241 0
The number of infant's registered to Early Childhood Education (ECE) / Te Kohanga Reo enrolment will be assessed by review of outcome data sourced by Ministry of Health (NZ) through the Ministry of Education's ELI collection of participating children's enrolment in ECE at 2 years of age.
Secondary outcome [7] 373243 0
To compare the Apgar scores for intervention and control cohorts
Timepoint [7] 373243 0
Apgar scores will be assessed by review of outcome data sourced by Ministry of Health (NZ) through the National Maternity Collection (MAT database).
Secondary outcome [8] 373244 0
To compare outcomes of infant mortality for intervention and control cohorts.
Timepoint [8] 373244 0
Infant mortality will be assessed by review of outcome data sourced by Ministry of Health (NZ) through the Mortality Collection which classifies the underlying cause of death for all deaths registered in New Zealand and all registerable stillbirths using the WHO Rules and Guidelines for Mortality coding. Time-points of collection will be at 1 year from delivery date and at 2 years from delivery date.

Eligibility
Key inclusion criteria
Women presenting in pregnancy or up to 6 weeks-post delivery presenting to participating intervention primary care practices who are enrolled as a patient with that practice will be eligible to receive the services offered through this research pathway.

A pregnant, or recently delivered women will be individually recruited and consented when they hold an appointment with the participating provider (GP or practice nurse). The woman is asked to provide informed consent for the future collection of outcome data (pregnancy and infant health information) to be shared with the research group for analysis. The woman is informed that the outcome data is de-identified and encrypted before being sent securely from the Ministry of Health contact to the research group.

All pregnancies, for which the woman has provided informed consent, will be analysed with the primary analysis on women who were enrolled before 20 weeks pregnant as these women are likely to have had benefit from the whole augmented best practice maternal care pathway as a result of health service change.
Minimum age
12 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not applicable

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Primary care practice allocation was concealed for this cluster randomised control trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a cluster randomised trial, with randomisation carried out for practices and each practice allocated to either the intervention or control arm. All eligible patients in a practice would receive the treatment allocated to the practice. Covariate constrained randomisation was used to minimize potential imbalance between intervention and control arms in the size of the Maori population aged less than one year. The following procedure was used:
Step 1: Identifying all possible allocations
a) Each practice was given a unique identifier: PXXXX
b) The set of all possible allocations to Control and Intervention arms were identified (using R software).
c) The total population size of Maori aged less than one year was calculated for the Control and Intervention arms for each allocation.


Step 2:
Retained only those allocations in which:
• there was at least one of the three large practices and one of the two medium sized practices in each arm
• the total population sizes of Maori aged < 1 year was roughly balanced between Control and Intervention arms


Step 3: Randomly select one of the remaining allocations after blinding to the practice identifiers (using R software)

This procedure had the advantage of achieving an acceptable allocation while retaining randomness in the selection process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
The primary outcome of interest in the hospital admission rates of babies in the first year of life. The number of discharges of infants less than 1 year old in the Hawkes Bay DHB in 2014/15 was approximately 1000 total of which approximately 600 (600/yr) are Maori and 400 (400/a year) are non-Maori.

In 2014, there were approximately 2000 pregnancies in Hawkes Bay, of which approximately 40% (800) are to Maori mothers. This gives annual hospital admission rates in the first year of life of 600/800 =0.75/infant/year for Maori and 400/1200=0.3/infant/year for non-Maori. If the intervention were to reduce the admission rate for Maori infants from 0.75 to 0.5 (Rate Ratio of 1.5), a standard two group design with individual randomization would require 96 Maori/group for a total of 192 to have 80% power to detect this difference at the 5% significance level, assuming we have one year follow-up for each infant.

The value of 96 was obtained using:
X_1=(2(Z_(1-a/2)+Z_(1-ß) )^2)/(log(r_1/r_2))^2 ,
where r_1/r_2=1.5 is the rate ratio we are interested in detecting, and Z_alpha is the 100×a quantile of the standard Normal distribution.
Therefore the sample size per arm under individual randomisation is 192 (half of whom are Maori). The design effect for a cluster randomised design was then calculated, taking into account unequal cluster sizes and used to obtain the required sample size.

Statistical analysis plan:
For all outcomes the primary focus is on Maori whanau as the control versus study intervention analysis with a further analysis of the whole cohort. All pregnancies will be analysed with the primary analysis on women who saw a practice before 20 weeks pregnant as these women are likely to have had benefit from the whole augmented care pathway. For the primary outcomes, multivariable Poisson regression models will compare the rates of infant hospitalizations until 1 year of age between the intervention and control group, after adjusting for potential personal and care-related confounders. Multivariable linear regression models will compare mean length of stay.

For the secondary outcomes, multivariable Poisson or logistic regression models will compare the rates of various obstetric, neonatal and other health factors until 2 years of age between the intervention and control group, after adjusting for potential personal and care-related confounders.

Descriptions of rates, rate ratios/ odds ratios and respective 95% confidence intervals will be reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/11/2018
Date of last participant enrolment
Anticipated
8/05/2020
Actual
Date of last data collection
Anticipated
15/07/2022
Actual
Sample size
Target
250
Accrual to date
100
Final
Recruitment outside Australia
Country [1] 21727 0
New Zealand
State/province [1] 21727 0
Hawkes Bay

Funding & Sponsors
Funding source category [1] 302836 0
Government body
Name [1] 302836 0
Health Research Council of New Zealand
Country [1] 302836 0
New Zealand
Primary sponsor type
University
Name
Victoria University of Wellington
Address
PO Box 600
Wellington
6149
Country
New Zealand
Secondary sponsor category [1] 302782 0
None
Name [1] 302782 0
Address [1] 302782 0
Country [1] 302782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303414 0
Health and Disability Ethics Committee
Ethics committee address [1] 303414 0
Ethics committee country [1] 303414 0
New Zealand
Date submitted for ethics approval [1] 303414 0
27/07/2017
Approval date [1] 303414 0
22/08/2017
Ethics approval number [1] 303414 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93594 0
Prof Bev Lawton
Address 93594 0
Centre for Women's Health Research
Victoria University of Wellington
PO Box 600
Wellington
6149
Country 93594 0
New Zealand
Phone 93594 0
+64 021463762
Fax 93594 0
Email 93594 0
[email protected]
Contact person for public queries
Name 93595 0
Francesca Storey
Address 93595 0
Centre for Women's Health Research
Victoria University of Wellington
PO Box 600
Wellington
6149
Country 93595 0
New Zealand
Phone 93595 0
+64 021 0237 5264
Fax 93595 0
Email 93595 0
[email protected]
Contact person for scientific queries
Name 93596 0
Bev Lawton
Address 93596 0
Centre for Women's Health Research
Victoria University of Wellington
PO Box 600
Wellington
6149
Country 93596 0
New Zealand
Phone 93596 0
+64 021463762
Fax 93596 0
Email 93596 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data provided by the Ministry of Health to the research team will be encrypted and deidentified. Results are aggregated and no individual practice or provider is identifiable.


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
SourceTitleYear of PublicationDOI
Dimensions AIHe Korowai Manaaki (Pregnancy Wraparound Care): Study Protocol for a Cluster Randomised Clinical Trial (Preprint)2021https://doi.org/10.2196/18154
N.B. These documents automatically identified may not have been verified by the study sponsor.