Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000071224
Ethics application status
Approved
Date submitted
9/11/2017
Date registered
17/01/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
He Korowai Manaaki: A Research Project of Pregnant Women to Test Whether Extra Free GP Appointments and a Way of Better Connecting Support Services Helps to Keep Mums and Babies Healthy.
Scientific title
He Korowai Manaaki Wairoa: A research project of pregnant women testing an augmented maternity care pathway to improve infant health outcomes.
Secondary ID [1] 292101 0
Health Research Council Funding 16/444
HDEC 17/STH/112 - NZ/1/CA9DO11
Universal Trial Number (UTN)
U1111-119701321
Trial acronym
HKM-W
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternity pathway 304592 0
Condition category
Condition code
Reproductive Health and Childbirth 303920 303920 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating in the study involves practice groups (midwifery group and general practice groups) being informed about the study and consenting to take part. GPs and midwives 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 (available through Med Tech) called Pregnancy Wraparound Care (PWC) has been designed to support the appointments with pregnant women and uploaded to the computer systems of the three primary care practices involved in the study.

The same system was offered to the maternity service group and access could be made available through another server but they felt it would not be necessary to utilise this additional framework.

To ensure both groups of providers were in a position to support referrals to allied services and be reminded about recommended best practice, the assessment prompts, health screening prompts, education resources, recall suggestions and connections for a wraparound service, a summary of the advanced form was shared with the maternity service as a PDF for reference.

Midwives, GPs and practice nurses are offered the same shared training and education refreshers sessions which cover utilization of the advanced form.

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 GP OR midwife - 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 GPs and midwives.

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] 299025 0
Prevention
Comparator / control treatment
The comparative group is a historical group whose outcomes will be compared to the outcomes of the intervention group. The comparative group will be deliveries between 18-30 months prior to study start date from the same practice groups.

The de-identified encrypted outcome information for women and their infants taking part in He Korowai Manaaki will be compared with similar information for women and infants in
Wairoa before the study began (the control group).

The Ministry of Health (NZ) will match the NHIs of each group to various data sources to obtain the relevant historical data required..
Control group
Historical

Outcomes
Primary outcome [1] 303254 0
To compare the number of infant hospitalisations for intervention and historical control cohorts
Timepoint [1] 303254 0
At one year of age for the delivered infant.
Outcome 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.
Primary outcome [2] 303255 0
To compare the number of timely vaccinations of infant for intervention and historical control cohorts
Timepoint [2] 303255 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] 340424 0
To compare pre and post natal smoking status for intervention and historical control cohorts determined by data entry by maternity care providers
Timepoint [1] 340424 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 cigatettes 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] 340425 0
To compare timely attendances (within 1 month of scheduled appointments) at Well Child Tamariki Ora infant checks for intervention and historical control cohorts
Timepoint [2] 340425 0
At 8-10 weeks, 3-4 months, 5-7- months, 9-12 monhts, 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] 340687 0
To compare the obstetric outcomes (Caesarean section) for intervention and historical control cohorts
Timepoint [3] 340687 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] 340688 0
To compare the gestational age at delivery for intervention and historical control cohorts
Timepoint [4] 340688 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] 340689 0
To compare infant registration to oral health services for intervention and historical control cohorts at 2 years of age
Timepoint [5] 340689 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] 340690 0
To compare Early Childhood Education (ECE) / Te Kohanga Reo enrollment for intervention and historical control cohorts at 2 years of age
Timepoint [6] 340690 0
The number of infant's registered to Early Childhood Education (ECE) / Te Kohanga Reo enrollment 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 enrollment in ECE at 2 years of age.
Secondary outcome [7] 340812 0
To compare the Apgar scores for intervention and historical control cohorts
Timepoint [7] 340812 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] 340813 0
To compare outcomes of infant mortality for intervention and historical control cohorts
Timepoint [8] 340813 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 Wairoa practices (GP and midwifery services) will be eligible to receive the services offered through this research pathway, at any time of presentation to a participating provider (GP, practice nurse or midwife).

A pregnant, or recently delivered women will be individually recruited and consented when they hold an appointment with the participating provider (GP, practice nurse or midwife). 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Recognizing the complexity of health systems and the need for an intervention that works in different Maori communities and care settings and most importantly has input and ownership for Maori, He Korowai Manaaki will be implemented in two phases. This registration concerns phase 1 (iwi based) which will inform a larger primary care randomised controlled trial (phase 2).

1. Iwi initiated model with Ngati Pahauwera.
2. Primary Heath Care /DHB model
Why two phases: By beginning with an iwi based model we enable our intervention to be more applicable for Maori communities and can build these learnings into models to enable system change to reduce disparities. “If we get it right for Maori we get it right for everyone” (kaumatua the late Dr Paratene Ngata). Phase 2 will test this model with recruitment through primary care.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/02/2018
Actual
27/02/2018
Date of last participant enrolment
Anticipated
30/06/2019
Actual
Date of last data collection
Anticipated
23/08/2021
Actual
Sample size
Target
120
Accrual to date
90
Final
Recruitment outside Australia
Country [1] 9176 0
New Zealand
State/province [1] 9176 0
Wairoa, Hawkes Bay

Funding & Sponsors
Funding source category [1] 296633 0
Government body
Name [1] 296633 0
Health Research Council of New Zealand
Country [1] 296633 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] 297012 0
None
Name [1] 297012 0
Address [1] 297012 0
Country [1] 297012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297865 0
Health and Disablity Ethics Committee
Ethics committee address [1] 297865 0
Ethics committee country [1] 297865 0
New Zealand
Date submitted for ethics approval [1] 297865 0
30/06/2017
Approval date [1] 297865 0
28/08/2017
Ethics approval number [1] 297865 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2007 2007 0 0
/AnzctrAttachments/373063-HDEC Letter 17STH112 Approved FULL Application with NSC (2).pdf (Ethics approval)
Attachments [2] 2218 2218 0 0
/AnzctrAttachments/373063-Pregnancy PIS CF He Korowai Manaaki Wairoa AMENDMENT 231117.pdf (Participant information/consent)
Attachments [3] 2219 2219 0 0
/AnzctrAttachments/373063-Practice PIS CF He Korowai Manaaki Wairoa AMENDMENT 231117.pdf (Participant information/consent)

Contacts
Principal investigator
Name 75310 0
Prof Bev Lawton
Address 75310 0
Centre for Women's Health Research
Victoria University of Wellington
PO Box 600
Wellington
6149
Country 75310 0
New Zealand
Phone 75310 0
+64 021 463762
Fax 75310 0
Email 75310 0
bev.lawton@vuw.ac.nz
Contact person for public queries
Name 75311 0
Francesca Storey
Address 75311 0
Centre for Women's Health Research
Victoria University of Wellington
PO Box 600
Wellington
6149
Country 75311 0
New Zealand
Phone 75311 0
+64 021 02375264
Fax 75311 0
Email 75311 0
francesca.storey@vuw.ac.nz
Contact person for scientific queries
Name 75312 0
Bev Lawton
Address 75312 0
Centre for Women's Health Research
Victoria University of Wellington
PO Box 600
Wellington
6149
Country 75312 0
New Zealand
Phone 75312 0
+64 021 463762
Fax 75312 0
Email 75312 0
bev.lawton@vuw.ac.nz

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 indiviudal practice or provider is identifable.


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.