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Scaling up an effective digital model of care to optimise child health in the first 2000 days: Is ‘opt-in’ or ‘opt-out’ the best approach?

Scaling-up a digital model of care to optimise child health in the first 2000 days: Comparing the impact of a clinician initiated ‘opt-in’ model versus an automated ‘opt-out’ approach on reach, effectiveness and health system cost.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000655549
Enrollment
4600
Registered
2024-05-21
Start date
2024-07-08
Completion date
2025-07-07
Last updated
2024-05-27

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

Conditions

None listed

Brief summary

Failure to address known risk factors in early life results in significant economic, social and health system burdens. While NSW Health is committed to enhancing child health and development during the First 2000 days (conception-5 years), child health in NSW remains poor. In NSW, Child and Family Health Nursing services provide routine Universal Health Home Visits. However, family engagement with face-to-face services are critically low, due to various health system (i.e. staff capacity) and parent challenges (i.e. incompatibility with family routines). Digital care models (e.g. text message) delivered direct to parents’ mobile phones presents an opportunity to revolutionise the delivery of universal health care across the First 2000 days. Effective models for scaling-up digital care to maximise reach and impact at the population level remains elusive. Provision of routine universal health care during the First 2000 days would be hugely valuable for this cohort and benefit all families in NSW. This research will compare two models of scaling-up an evidence-based digital program targeting child health and development in the First 2000 days (HB4HNEKids). Community and Family Health Nurse services in Hunter New England (HNE) will be randomised to receive either an automated ‘opt-out’ model or clinician initiated ‘opt-in’ model of offering HB4HNEKids to families. The automated ‘opt-out’ model will automatically enrol parents into receiving HB4HNEKids as the intervention will be integrated within existing digital clinical systems. The clinician initiated ‘opt-in’ model will use evidence-based strategies to support clinicians to implement systematic offers to parents to ‘opt-in’ to HB4HNEKids. It is hypothesised that the clinician initiated ‘opt-in’ model will be more impactful (i.e. have high reach and greater effectiveness), however we hypothesise that the automated ‘opt-out’ model will have greater reach, representative of the population and be more cost effective to deliver.

Interventions

Healthy Beginnings for Hunter New England Kids (HB4HNEKids) is a digital health model of care delivered via mHealth (text message) that provides families with easy to access evidence based age and stage related preventive health information, targeting child health and development such a breastfeeding, child nutrition, movement behaviours and family/carer wellbeing, from birth to 5 years. Messages may also include immunisation and personal health and development check reminders. Families eligibl

Healthy Beginnings for Hunter New England Kids (HB4HNEKids) is a digital health model of care delivered via mHealth (text message) that provides families with easy to access evidence based age and stage related preventive health information, targeting child health and development such a breastfeeding, child nutrition, movement behaviours and family/carer wellbeing, from birth to 5 years. Messages may also include immunisation and personal health and development check reminders. Families eligible for HB4HNEKids receive short text messages (160 characters) with clickable links to evidence based ‘online’ videos, fact sheets, websites and relevant support services on average once/week in the first 3 years, and once/fortnight up until the age of 5 years. T he delivery of text messages are monitored via direct SMS reports (i.e. the number of messages successfully delivered), and engagement with text message context is monitored via a URL tracking platform ‘T2M’. As part of the this trial, the intervention will focus on the implementation of an automated (opt-out) model. This will involve an automated health system intervention where parents will automatically receive the HB4HNEKids text message program and are able to ‘opt-out’. This will involve using existing data systems to generate reports to identify parents referred to the Community and Family Health Nursing (CFHN) service and eligible to receive HB4HNEKids. Client lists will be generated from these reports that will be used to trigger the commencement of the HB4HNEKids mHealth intervention direct to all parents mobile phones. HB4HNEKids has been designed to be delivered to eligible parents alongside usual CFHN care. During the course of the intervention, parents will have multiple ways to opt out of the program. On average they will receive three text message links per year to opt out of the program, which they can return to at any time. An opt out link is available on the contact us section of the program website, as well as direct contact information (email and contact phone number) for the project team. During any interaction with the Child & Family Health Nursing Service families can also request to cease receiving the text messages. The following strategies will be delivered to CFHN services via the generic program email: 1. A contact from each sector will be identified to distribute program information to CFHN clinicians. 2. A district wide report will be distributed to CFHN clinicians quarterly.

Sponsors

HNELHD
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

51 CFHN services, located across 7 sectors (Tablelands, Peel, Mehi, Lower Mid North Coast, Maitland/Lower Hunter, Hunter Valley and Greater Newcastle) of the Hunter New England local health district of New South Wales Australia will be eligible for implementing the scale-up of HB4HNEKids . These services offer care to approximately 10,000 new families each year. Parents are eligible if they own a mobile phone, and are eligible for CFHN appointments provided by the 51 CFHN services mentioned above.

Exclusion criteria

Families that are not eligible for standard CFHN care will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026