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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001155189
Acronym
HKM-RCT
Enrollment
100
Registered
2019-08-19
Start date
2018-11-13
Completion date
2020-05-08
Last updated
2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The trial of He Korowai Manaaki (pregnancy wraparound care) provides more opportunities for pregnant women to receive health care and seeks to support them with other needs and priorities that they may have (e.g., oral health, transport, contraception). Primary care practices will be supported and funded to provide best practice with a clinical and whanau wrap: an extended first maternity visit (whanau needs assessment, navigation to midwife and other appropriate services), a follow-up visit, a third trimester visit and a 6-week postnatal GP maternity visit. The implementation of a comprehensive wraparound approach to the pregnancy pathway (He Korowai Manaaki) will improve maternal and infant health outcomes for Maori.

Interventions

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 suppo

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

Sponsors

Victoria University of Wellington
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
12 Years to 60 Years
Healthy volunteers
Yes

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.

Exclusion criteria

Not applicable

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 16, 2026