Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001079235
Ethics application status
Approved
Date submitted
17/06/2018
Date registered
28/06/2018
Date last updated
28/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
HARTI HAUORA TAMARIKI
A Randomised Controlled Trial of an Opportunistic, Holistic and Family Centred Approach to Improving Outcomes for Hospitalised Children and their Families
Scientific title
HARTI HAUORA TAMARIKI
A Randomised Controlled Trial of an Opportunistic, Holistic and Family Centred Approach to Reducing Risk of Readmission and Other Health Risks for Hospitalised Children and their Families
Secondary ID [1] 295153 0
None
Universal Trial Number (UTN)
U1111-1202-4704
Trial acronym
HHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute paediatric medial admission or readmission 308258 0
Condition category
Condition code
Emergency medicine 307278 307278 0 0
Other emergency care
Public Health 307514 307514 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME: The Harti Hauora Tamariki Tool.
The intervention consists of the application of the Harti Hauora Tamariki Tool (HHT) to children admitted acutely to a paediatric medical ward at Waikato Hospital New Zealand.. The Harti Hauora Tamariki tool (HHTt) is based on a Whanau Ora approach and weaves Kaupapa Maori methodology into the provision of hospital-based health care. It consists of a checklist of 22 components of importance to holistic child and whanau health. These are:
1. Registration with a general practitioner. This is assessed by specific questions incorporated in the HHT.
2. Enrolment with a Well Child/Tamariki Ora provider. The Well Child Tamariki Ora programme is a series of health visits and support that are free to all families for children from around 6 weeks up to 5 years of age. The service is provided by Plunket and other accredited providers. Enrolment is assessed by specific questions incorporated in the HHT.
3. Completion of a "Before School Check". This is the last Well Child Tamariki Ora checkup which takes place when the child is 4 years of age. It is funded by the Ministry of Health. It is performed by a nurse who checks the child's height and weight, their teeth, and his/her general health and learning development. It also provides caregivers with an opportunity to get professional advice and support about their child's health and development.
4. Enrolment in an early childhood education facility. This is assessed by specific questions incorporated in the HHT.
5. Oral health assessment consisting of (a) determining whether an oral health check has been conducted in the preceding 12 months and (b) recording the "Lift the Lip Score", referring to an oral health provider as appropriate. This assessment is conducted as an integral part of the HHT.
6. Immunisation status check and update as required for the index child, any pregnant women in the household, and any other members of the household (for flu vaccination). This is done by checking the child's immunisation status on the National Immunisation Register and by asking about the immunisation status of other members of the household.
7. Housing and safety to check whether the house is adequately insulated and to perform a home safety checklist. This is assessed by specific questions incorporated in the HHT. A referral is made to the Whare Ora programmes if eligible and agreed by the care-giver. The Whare Ora programme can offer families products and services such as heating devices, thermal curtains, draught stoppers, mould kits, blankets, pillows and subsidised insulation referrals.
8. Smoking by the parent / caregiver or other members of the household, offering advice and support to quit. This is assessed by specific questions incorporated in the HHT. Referrals to smoking cessation services are made on the spot where agreed and appropriate.
9. Drug and alcohol use screen with referral as appropriate. If the screening question (part of HHT is positive) then the research assistant proceeds to conduct an Audit C assessment, and depending on the result, a Full Audit. Based on the score the interventions delivered might include no action, brief advice, referral to the Family Start service (see https://www.health.govt.nz/our-work/life-stages/child-health/well-child-tamariki-ora-services/family-start) for details, referral to other community service providers or referral to the patients' GP.
10. Family violence assessment with four screening questions incorporated in the HHT. Interventions include women's refuge information, referral to a DHB social worker, referral to or information about Family Start, and if appropriate completing the Intimate Partner Violence Health Assessment process (details available at https://www.health.govt.nz/system/files/documents/pages/intimate-partner-violence-intervention-policy-mar17.doc)
11. Problem gambling. Assessed by specific questions within the HHT. Where appropriate additional information (e.g. the Problem Gambling Foundation brochure) or a referral to the Salvation Army Oasis Centre for Problem Gambling is provided.
12. Eligibility and registration with support services (Community Services Card; National Travel Assistance, Work and Income NZ subsidies etc.). An assessment of eligibility is conducted within the HHT with interventions ranging from providing information to assisting with applications for National Travel Assistance prescription subsidies, Work and Income New Zealand subsidies and benefits, DHB social worker assistance, Family Start, Spark JUMP package information, Te Whare Kokanga, Salvation Army, accommodation at Te Whare Taurima.
13. Breastfeeding. The HHT ascertains if there is current breastfeeding and if there are problems with this, then a referral to a lactation consultant is offered or other resources such as the Ministry of Health "Breastfeeding for your baby" brochure, the Mama Aroha App and the Midlands Breastfeeding App BreastfedNZ.
14. Car restraints. The HHT checks whether the family has adequate car seats and restraints for the children and where this is not the case it may refer to whanau ora booklet, to ‘In loving arms’ if under 1 years, to health shuttle services or K’aute for use of car restrains/travel for health appointments, or provide ‘Car restraints save lives’ NZTA pamphlet
15. Safe sleep check for those aged 6 months or less. If no safe place to sleep the baby then the research assistant plays the Safe Sleep DVD or offers to provide a Pepi Pod.
16. Power to protect (shaken baby) DVD viewing for parents of children under the age of 2 years if accepted.
17. Sore throat check for index child and other household members. Whether or not the screening question is positive the Sore Throats Matter message is promoted and if positive then a referral to Pharmacy on Meade for community throat swabbing services if eligible.
18. Body mass index and intervention as required. The interventions may include referral to the GP, growth charting, "Be Smarter" messages, and referrals to Sport Waikato or Bodywise for older children in the Whanau.
19. Developmental assessment. If the caregiver has concerns about the child's development then a milestones checklist is performed. If the criteria are met then the child is referred to the Waikato DHB Child Development Centre (if the caregiver is in agreement).
20. Skin condition check. If there are concerns about the index child's skin or the skin of other children in the whanau, then the hospital medical team is informed (or the GP referred to for other children). Resources such as "Stop Skin Infections" brochures, eczema or head lice information is provided.
21. Vision and hearing check. If the caregive has concerns about the child's hearing or that of other children in the whanau then the Research Assistant may inform the medical team, refer to the GP, make and appointment with a private optometrist, or (for those aged 4-17) make an appointment with the vision and hearing screening clinic.
22. Review of past admission frequency. This is done by consulting the iPM (electronic hospital admissions database) to determine whether the child has had 5 or more admissions in the preceding 6 months. If so, the medical team is alerted to this.
The time taken to complete the HHT is recorded. It is expected that this will vary from 30 minutes to over 2 hours, depending on the number of interventions required.
The HHT and its associated interventions are delivered by one of three Research Assistants during a face to face consultation with the child's parent or caregiver while the child is admitted to hospital. If the child is discharged home before the HHT can be administered, then it will be performed by appointment. The tool is applied just once with most activity undertaken on the spot, but sometime follow-up actions may be required which are performed after the consultation has ended.
Intervention code [1] 301491 0
Early detection / Screening
Intervention code [2] 301492 0
Prevention
Intervention code [3] 301493 0
Lifestyle
Comparator / control treatment
The control group is usual care with no application of the Harti Hauora Tamariki tool. There are no specific guidelines as to what constitutes usual care.
Control group
Active

Outcomes
Primary outcome [1] 306232 0
The risk of an acute hospital readmission within 12 months of the index admission event. Since this is a risk and not a rate, only the first acute hospital readmission will be counted and the patient will be censored from that point. Acute readmission is defined as:
- a new patient admission to a paediatric ward or emergency department with a date/time at least 24 hours after the date/time of discharge from the index admission event
- and where the length of stay was greater than 3 hours
- and where the admission is coded as acute (i.e. not arranged or elective)
- and where the admission was not for palliative or elective care
- and it was not a transfer from another hospital or hospital service
who is formally admitted to one of the Waikato District Health Board's paediatric medical wards or emergency departments and whose admission is coded as acute (i.e. not planned or elective) and whose admission was not for palliative care. Electronic hospital admission records linked to the patient's NHI number will be used to assess the fact of acute hospital readmission, and to ensure the definition is fully met.
Timepoint [1] 306232 0
12 months from the date of discharge from the index admission.
Secondary outcome [1] 347954 0
The overall difference in satisfaction with hospital experience reported by the child's primary care-giver between the intervention and control groups.

This will be measured from the first 7 questions in the Patient Satisfaction with Hospital Care (Marama) questionnaire plus a question on responsiveness to whanau needs and another on whether a holistic approach was employed.
Timepoint [1] 347954 0
This will be measured with 24 hours of discharge from the index hospital admission or within one month post discharge.
Secondary outcome [2] 347955 0
Difference in preventive services utilisation and access between the intervention and control groups. This is a composite outcome in two parts. Part A - Documentation.

External sources (i.e. additional to the medical record) will be used to determine whether at admission the child was (i) enrolled with a GP (using the NChip database from Pinnacle Midlands Network); (ii) enrolled with the oral health services (using the Titanium Database); (iii) up to date with all immunizations (using the National Immunizations Register); (iv) up to date with WCTO visits (using the NChip database from Pinnacle Midlands Network). Where ‘non-compliance’ is documented with any of these services, the patient’s HHT record, or medical record for Usual Care (UC) patients will be examined post-discharge to determine whether that non-compliance was documented.

The indicator that will be compared between the HHT and UC groups is the number of children with non-compliances in any of the four domains (GP enrolment, oral health enrolment, up-to-date immunisation, and up to date WCTO visits) in whom this has been fully documented in the HHT or patient record during the child’s admission, divided by the total number of children with non-compliance in any of these four domains.

Non-compliance (used in an entirely non-pejorative sense) is defined as: not being enrolled with a GP, not being up to date with immunizations, not being up-to-date with WCTO (including before school check) or not being up-to-date with oral health checks.
Timepoint [2] 347955 0
This will be measured from the medical record as it stands at the date and time of discharge from the index admission.
Secondary outcome [3] 347956 0
Difference in preventive services utilisation and access between the intervention and control groups. Part B - Achievement (the second part of a two-part composite outcome)..
The proportion of children who at admission were non-compliant (as defined for secondary outcome 2 and assessed using the data sources specified for that outcome) on any of the four domains (enrolment with a GP; enrolment with oral health services; up to date with all immunizations; up to date with Well Child Tamariki Ora visits), and who became fully compliant within 30 days of discharge from the hospital. Fully compliant is defined as all of the following; enrolment with a GP, enrolment in oral health services, complete immunization (for age) having had at least one dose of catch-up immunizations (where full immunization would require more than 30 days) and complete WCTO participation.
Timepoint [3] 347956 0
At 30 days post discharge.
Secondary outcome [4] 347957 0
Referral to smoking cessation services.
The proportion of households documented to have one or more smokers resident for which at least one referral was made during the hospitalisation period for cessation services. This will be calculated by sending a list of addresses to the smoking cessation provider of households documented to have at least one resident who smokes. The provider will then confirm if a referral had been received for that address during the admission/hospitalisation period.
Timepoint [4] 347957 0
Measured at the time of the child's discharge from hospital for the index hospitalisation event.
Secondary outcome [5] 347958 0
Referral to Whare Ora

The difference between HH and UC groups in the proportion of children for whom a Whare Ora referral was made within 30 days post-discharge.

This will be calculated simply as the number of Whare Ora referrals in each group divided by the total number of study children in that group. Any child can be counted only once in the numerator.
Timepoint [5] 347958 0
30 days post-discharge from the index hospitalisation event.
Secondary outcome [6] 347959 0
Cumulative hospital length of stay.

The differences between HHT and UC in median cumulative length of stay (LOS) in acute hospital admissions in the 12 months following discharge.

Data to measure this outcome will be drawn from the electronic hospital admission database. Only coded events with lengths of stay of 3 hours or more will be included in the calculation. Length of stay will be calculated in hours from the time of admission to the time of discharge using the hospital time stamp records. Length of stay will be calculated using, where appropriate, the rules established in the Ministry of Health’s LOS indicator. These join events within the same DHB where there is a transfer between the two and the second event commences less than 24 hours after the end of the prior event. In these cases, if the initial admission is not acute then this and any length of stay in a joined subsequent hospitalisation, even if acute, will not be counted. Hospitalisations where none of the contributing stays is case-mix coded will also therefore be excluded, consistent with these rules.

This endpoint will be calculated as the difference in median cumulative lengths of stay by individual (i.e. not summing for the group as a whole) and will include acute hospital stays at any hospital in Waikato DHB. Using medians and individual level data will avoid outlier cases with very long lengths of stay having undue influence on the result of the test.
Timepoint [6] 347959 0
12 months from the date of discharge from hospital for the index hospitalisation event.
Secondary outcome [7] 347960 0
Frequency of readmission.

This endpoint will be calculated as the rate ratio of acute readmission in the 12 months following discharge from the index admission event. Data will be drawn from the electronic hospital admission records.

It differs from the primary endpoint in using all admissions in the numerator, and a person-time denominator which will exclude any days in which the patient is in hospital.
Timepoint [7] 347960 0
12 months from the date of discharge from hospital for the index hospitalisation event.
Secondary outcome [8] 347961 0
Time to (first) readmission in the intervention group compared with the control group. This will be based on electronic hospital record data.
Timepoint [8] 347961 0
Measured over the 12 months from the date of discharge from the index hospitalisation event with subjects censored from the time of the first rehospitalisation event.

Eligibility
Key inclusion criteria
• Residence in the catchment area of Waikato District Health Board
• Acute medical admission to a paediatric ward at Waikato Hospital

An acute medical admission is defined as a patient with a length of stay greater than 3 hours and who is formally admitted to one of the Waikato Hospital’s acute paediatric medical wards and whose admission is coded as acute (i.e. not arranged or elective) and whose admission was not for palliative care..

Neonates are eligible for the trial but will only be included if admitted to an acute paediatric ward and not if they are admitted to the neonatal intensive care unit.
Minimum age
No limit
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who have already entered the study
• Patients who are not eligible for publicly funded healthcare in New Zealand
• Arranged or wait list admissions to paediatric wards at Waikato Hospital
• Patients who are not a current resident in Waikato DHB at the time of admission
• Patients with severe illness deemed by their medical team likely to die within 6 months of admission. This will be advised by the charge nurse who will provide a daily list of patients not to approach.

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)
Allocation concealment will be performed by a central process of computer randomisation using the software Qualtrics (www.qualtrics.com). It is not possible to change group allocation once the patients details are introduced. I
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A web-based randomisation process using the Qualtics platform is to be employed. The programme uses a Mersenne Twister as its pseudorandom number generator.
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
A total of 1100 subjects will be recruited to the study, of whom we expect 43% will be Maori (based on current figures and expected acceptability of the research protocol). This sample has been calculated to ensure that there is sufficient statistical power to detect a 7% absolute reduction in the 12-month readmission risk in the HHT group for all children as a collective/total (from an expected 28%) and a 12% absolute reduction in the 12-month acute readmission risk in Maori. Sample size calculations were based on a two-tailed 0.05 level of significance with 80% power. We are assuming that the acceptability of participation will be similar for Maori and Non-Maori.

We will measure differences between the intervention and control groups in the primary endpoint measures controlling for age, sex, ethnicity, primary diagnostic grouping and geographical area of residence. The study is not powered to test for heterogeneity of the impact of HHT between Maori and non-Maori.

Analysis will be performed on an intention to treat basis. That is, endpoints will be compared for the two groups as defined from the point of randomisation to intervention or control group. For the primary endpoint participants who are readmitted multiple times from each group will be included in the analysis only for the first (valid) occasion on which they are readmitted in the 12 months following the index admission.
The sample size calculation was worked out for a risk as that is simpler from an analytic point of view. If we counted each readmission, then we would be measuring a rate which needs a person-time denominator. There is a danger that the use of a rate will be biased by a few individuals with frequent readmissions however this is being calculated as a secondary endpoint.

Bivariate analyses comparing groups will test for statistical significance using the Chi Square test for differences in proportions. For the length of stay secondary endpoint where a difference in medians is to be tested, the Mann-Whitney U test will be used.

Although the randomised design is expected to yield balanced intervention and control groups in a study of this size, logistic regression analysis will be used for the primary and secondary endpoints to control for important confounding variables and to facilitate the assessment of interaction variables that increase or decrease the efficacy of the HHT. Statistical significance will be tested at the alpha level of 0.05. We will control for the false discovery rate in the secondary endpoints using the Benjamini-Hochberg method .

The study is not powered to detect ethnic differences in the impact of HHT (effect modification). However, we will nevertheless conduct exploratory tests for effect modification with ethnicity (Maori/non-Maori), gender (male/female excluding other), and deprivation (as a dichotomised variable) using the Breslow Day test for homogeneity of odds ratio, and standard maximum likelihood methods (likelihood ratio tests) based on binomial regression models. We will assume an additive interaction for these analyses and report the relative excess risk due to interaction (RERI) where this is significant.

Although the main outcome is the relative risk of acute hospital readmission within twelve months of discharge, we will also measure as prespecified analyses the relative risk of acute readmission within one month of discharge, and from one to six months from the index admission event. This will examine whether the observed effect of the intervention on readmission rates occurs with a short or medium time frame. These analyses are exploratory as the trial has not been powered to detect difference within these time frames (although it may have adequate power to do so).

For the time to first acute hospital readmission outcome the analysis will measure the hazard ratio between intervention and control groups. A Kaplan-Meier analysis to compare the ‘survival’ functions of intervention and control groups where survival in this case is taken to mean time following discharge without hospital readmission.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment outside Australia
Country [1] 10544 0
New Zealand
State/province [1] 10544 0
Waikato

Funding & Sponsors
Funding source category [1] 299742 0
Government body
Name [1] 299742 0
Health Research Council of New Zealand
Country [1] 299742 0
New Zealand
Primary sponsor type
Government body
Name
Waikato District Health Board
Address
Pembroke Street
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 299079 0
None
Name [1] 299079 0
Address [1] 299079 0
Country [1] 299079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300633 0
Health and Disability Ethics Committee
Ethics committee address [1] 300633 0
Ethics committee country [1] 300633 0
New Zealand
Date submitted for ethics approval [1] 300633 0
08/05/2018
Approval date [1] 300633 0
29/05/2018
Ethics approval number [1] 300633 0
18/CEN/88

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

Contacts
Principal investigator
Name 84278 0
Dr Nina Scott
Address 84278 0
Te Puna Oranga, Hockin L1
Pembroke Street
Waikato District Health Board
Hamilton 3204
Country 84278 0
New Zealand
Phone 84278 0
+6421907513
Fax 84278 0
Email 84278 0
nina.scott@waikatodhb.health.nz
Contact person for public queries
Name 84279 0
Amy Jones
Address 84279 0
Te Puna Oranga, Hockin L1
Pembroke Street
Waikato District Health Board
Hamilton 3204
Country 84279 0
New Zealand
Phone 84279 0
+6478398899 ext. 97548
Fax 84279 0
Email 84279 0
amy.jones2@waikatodhb.health.nz
Contact person for scientific queries
Name 84280 0
Nina Scott
Address 84280 0
Te Puna Oranga, Hockin L1
Pembroke Street
Waikato District Health Board
Hamilton 3204
Country 84280 0
New Zealand
Phone 84280 0
+6478398899 extension 97558
Fax 84280 0
Email 84280 0
nina.scott@waikatodhb.health.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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