Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001691831
Ethics application status
Approved
Date submitted
2/11/2021
Date registered
10/12/2021
Date last updated
3/06/2024
Date data sharing statement initially provided
10/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Whaioranga te Pa Harakeke – the effect of a Paearahi intervention on unintentional injury and recovery from injury in older Maori
Scientific title
Whaioranga te Pa Harakeke – the effect of a Paearahi intervention on unintentional injury and wellbeing in older Maori
Secondary ID [1] 305899 0
None
Universal Trial Number (UTN)
U1111-1270-3503
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental injury 323919 0
Condition category
Condition code
Injuries and Accidents 321433 321433 0 0
Other injuries and accidents
Public Health 321942 321942 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention(s) / exposure: Koeke (older Maori) injury-specific intervention
Paearahi (health navigators) will deliver the intervention to koeke in their own homes (or in a mutually agreed location). Participants will be able to invite whanau (family members/support people) to be present during the consent process and intervention delivery.
The intervention detailed below relates to the injury-specific intervention, which is a being tested in the current study.
The intervention will include the following components:
- home assessment to assess the risk of injury hazards and development of an action plan to address issues. This includes assessing for trip hazards, lighting issues, functioning smoke alarms
- teaching strength and balance exercises that can be undertaken in their own homes and which are responsive to the individual needs and capabilities. Examples of exercises are: hamstring curls, small squats, back leg raises, side leg raises, toe stand, flamingo, walking the line, wall push-up, hip flex, step over, sit to stand. Participants will be advised to do all these exercises (approximately 30 minutes) three times a week as they are able. Participants will be asked to record frequency and duration.
- education about injury prevention, rehabilitation and Accident Compensation Corporation (ACC) access
- falls-risk assessment and basic health screening (https://www.hqsc.govt.nz/assets/Falls/PR/LSFL-AAA-Information-poster-Jun-2018.pdf) to identify whether referral to other health and social service providers* is required. The health screening involves asking simple questions within a number of different domains (including physical function, feet, vision, continence, nutrition, and medications). For example, in the continence domain, participants will be asked: do you have trouble making it to the toilet in time?
*Referral pathways are already established within the current hauora practices and would follow the same pathways that are already available. However, paearahi will help koeke navigate these systems. Providers that are likely to be referred to include: general practitioners, Geriatric/Gerontology Nurse Specialist referral (likely initiated through GP), practice nurse, pharmacist medicine review, occupational therapist, physiotherapist, rongoa practitioners, counsellors, optometrist, podiatrist, nutritionist, community exercise programmes, social and welfare services.
The intervention will be delivered over a 12-week period with the paearahi making at least 4 in-person/telehealth visits (initial visit plus every 4 weeks; duration of one hour) and weekly phone calls. There will be no maximum number of visits as the model is designed to respond to holistic needs, although it is unlikely that more than 12 visits (i.e once weekly) would be undertaken. The weekly phone-calls will be ‘check-ins’ so would be a minimum of 5 minutes for each person, but could be longer if action or follow up was required. Participants will be asked how they are doing, if they have sustained any injuries and if they are managing exercises. Any action identified in the in-person or telehealth visits will be discussed.
No physical informational material will be provided as a standard part of the intervention.
Multiple components will be undertaken at each visit.
Paearahi will record all interactions on pre-designed data collection forms including frequency and duration of interactions. Participants will be given a diary or wall calendar to record exercise frequency and duration and injuries.
For the home assessment, issues identified and action taken will be recorded by the paearahi.
For the education session, the paearahi will record that it has been completed and who was present during the education (may be family members/support people also present).
Paearahi training for the injury prevention/rehabilitation component will require completion of 4 x 3hour modules, likely delivered over a two week period. Module One will focus on injury in older adults and the research protocol, Module Two will focus on home assessment and referral pathways, Module Three will focus on the health assessment and referral pathways, Module Four will focus on research data collection, documentation, and evaluation. The training will be delivered in person by different researchers and health professionals, dependent on the specific module. Where specific content is delivered by experts who live outside the study location, video conferencing will be used - this is likely to only happen for the module one (injury in older adults and study protocol). Paearahi will be required to read the study protocol, some background information specific to each module as well as the data collection forms prior to the module. Module One will be delivered by a clinical academic general practitioner with expertise in falls prevention in older adults, and the study principal investigator. Module Two will be lead by one of the research team members with expertise in workforce development; expertise will be brought in from community occupational therapists. Module Three will be lead by the managers from the three research general practices (registered clinicians) with input from the expert GP already mentioned. Module Four will be led by the researcher leading the evaluation with input from the principal investigator.
Intervention code [1] 322101 0
Prevention
Intervention code [2] 322292 0
Lifestyle
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329700 0
The number of unintentional injury-related ACC claims (as measured by number of ACC claims in the national ACC claims database)
Timepoint [1] 329700 0
Comparison of 12 months pre- and post-recruitment, grouped into the following categories for analysis: 0-30 days, 31-90 days, 91-180 days, 180-360 days.
Secondary outcome [1] 402597 0
Wellbeing (as measured using the Whakaahua wheel assessment)
Timepoint [1] 402597 0
Base line and 12-weeks post-intervention (i.e 12-weeks post-first paearahi visit)
Secondary outcome [2] 402598 0
Strength measured using Timed Up and Go
Timepoint [2] 402598 0
Base line and 12-weeks post-intervention (i.e 12-weeks post-first paearahi visit)
Secondary outcome [3] 402599 0
Fear of falling using Falls efficacy scale
Timepoint [3] 402599 0
Base line and 12-weeks post-intervention (i.e 12-weeks post-first paearahi visit)
Secondary outcome [4] 402600 0
Number of falls assessed through participant self-report over last 3 months
Timepoint [4] 402600 0
Base line and 12-weeks post-intervention (i.e 12-weeks post-first paearahi visit)
Secondary outcome [5] 402601 0
Injury hazards identified in the home will be assessed by the paearahi using the ACC home assessment checklist https://www.acc.co.nz/assets/injury-prevention/acc5218-how-safe-your-home.pdf
Timepoint [5] 402601 0
Base line and 12-weeks post-intervention (i.e 12-weeks post-first paearahi visit)
Secondary outcome [6] 402602 0
Actions taken to address issues (injury-related and other) will be assessed by paearahi documenting action taken.
Timepoint [6] 402602 0
12-weeks post-intervention.
Secondary outcome [7] 402603 0
Experiences and perceptions of the intervention assessed using 30-minute audio-recorded semi-structured one-on-one interviews with koeke participants. The topic guide for the interviews is structured around: positive aspects of the paearahi intervention; challenges or opportunities for improvement in paearahi model; change in confidence relating to injury prevention through intervention; paearahi training; injury and ACC related knowledge; whanau involvement; collective outcomes from the intervention; likelihood to utilise a similar programme in the future.
Timepoint [7] 402603 0
4 weeks post intervention completion
Secondary outcome [8] 402604 0
Number of unintentional injury-related primary care contacts assessed using primary care contact records with data query being run in the electronic Patient Management System at the general practice.
Timepoint [8] 402604 0
All primary contacts for unintentional injury in the 2 months pre- and post-recruitment, grouped into the following categories for analysis: 0-30 days, 31-90 days, 91-180 days, 180-360 days.
Secondary outcome [9] 402606 0
Number of unintentional injury-related hospitalisations accessed from the NZ Ministry of Health using National Minimum Dataset
Timepoint [9] 402606 0
Comparison of 12 months pre- and post-recruitment, grouped into the following categories for analysis: 0-30 days, 31-90 days, 91-180 days, 180-360 days.
Secondary outcome [10] 402607 0
Number of emergency department visits accessed from the NZ Ministry of Health using National Minimum Dataset
Timepoint [10] 402607 0
Comparison of 12 months pre- and post-recruitment, grouped into the following categories for analysis: 0-30 days, 31-90 days, 91-180 days, 180-360 days.
Secondary outcome [11] 403508 0
Balance measured using Short-Physical Performance Battery (SPPB) score
Timepoint [11] 403508 0
Base line and 12-weeks intervention (i.e 12-weeks post-first paearahi visit)
Secondary outcome [12] 403509 0
Experiences and perceptions of the intervention assessed using 30-minute audio-recorded semi-structured one-on-one interviews with family members. The topic guide for the interviews is structured around: positive aspects of the paearahi intervention; challenges or opportunities for improvement in paearahi model; change in confidence relating to injury prevention through intervention; paearahi training; injury and ACC related knowledge; whanau involvement; collective outcomes from the intervention; likelihood to utilise a similar programme in the future.
Timepoint [12] 403509 0
4-weeks post intervention completion.
Secondary outcome [13] 403510 0
Experiences and perceptions of the intervention assessed using 30-minute audio-recorded semi-structured one-on-one interviews with paearahi. The topic guide for the interviews is structured around: positive aspects of the paearahi intervention; challenges or opportunities for improvement in paearahi model; change in confidence relating to injury prevention through intervention; paearahi training; injury and ACC related knowledge; whanau involvement; collective outcomes from the intervention; likelihood to utilise a similar programme in the future.
Timepoint [13] 403510 0
4-weeks post-intervention completion.
Secondary outcome [14] 403511 0
Cost-effectiveness assessed using cost of paearahi resource versus change in number of hospitalisations over a 12month period. Standardised costs of hospitalisation will be used in calculations.
Timepoint [14] 403511 0
12 months pre-intervention and 12-months post-intervention, data analysed for the entire 12month period rather than splitting into smaller time periods.
Secondary outcome [15] 403517 0
Paearahi intervention implementation will be assessed using 30-minute audio-recorded semi-structured one-on-one interviews with paearahi. The topic guide for the interviews is structured around: positive aspects of the paearahi intervention; challenges or opportunities for improvement in paearahi model; change in confidence relating to injury prevention through intervention; paearahi training; injury and ACC related knowledge; whanau involvement; collective outcomes from the intervention; likelihood to utilise a similar programme in the future.
Timepoint [15] 403517 0
4 weeks post-intervention completion.
Secondary outcome [16] 403519 0
Paearahi confidence relating to injury prevention will be assessed using 30-minute audio-recorded semi-structured one-on-one interviews with paearahi. The topic guide for the interviews is structured around: positive aspects of the paearahi intervention; challenges or opportunities for improvement in paearahi model; change in confidence relating to injury prevention through intervention; paearahi training; injury and ACC related knowledge; whanau involvement; collective outcomes from the intervention; likelihood to utilise a similar programme in the future.
Timepoint [16] 403519 0
4 weeks port intervention completion
Secondary outcome [17] 403521 0
Paearahi knowledge relating to injury prevention will be assessed using 30-minute audio-recorded semi-structured one-on-one interviews with paearahi. The topic guide for the interviews is structured around: positive aspects of the paearahi intervention; challenges or opportunities for improvement in paearahi model; change in confidence relating to injury prevention through intervention; paearahi training; injury and ACC related knowledge; whanau involvement; collective outcomes from the intervention; likelihood to utilise a similar programme in the future.
Timepoint [17] 403521 0
4 weeks post intervention
Secondary outcome [18] 403527 0
Programme dosage will be measured by paearahi recording frequency and duration of intervention visits and phone calls.
Timepoint [18] 403527 0
This will be assessed at each contact, with weekly review to ensure accurate recording.
Secondary outcome [19] 403528 0
Programme fidelity will be measured by paearahi recording frequency and duration of intervention visits and phone calls and comparing this to the intended number of visits and duration of visits set out in the original protocol. This will also be assessed using qualitative interviews described earlier.
Timepoint [19] 403528 0
This will be assessed at each contact, with weekly review to ensure accurate recording.
Secondary outcome [20] 403529 0
Recovery from injury will be assessed using the Whakaahua wheel which assesses wellbeing an the Hua Oranga tool which assessed impact of the intervention on the individual. These are both holistic measures.
Timepoint [20] 403529 0
Whakaahua assessment will be undertaken at base line and 12-weeks post-intervention (i.e 12-weeks post-first paearahi visit).
Hua Oranga assessment will be undertaken 12-weeks post-intervention (i.e 12-weeks post-first paearahi visit)
Secondary outcome [21] 403530 0
Participant confidence in accessing injury-related care assessed using 30-minute audio-recorded semi-structured one-on-one interviews with koeke participants. The topic guide for the interviews is structured around: positive aspects of the paearahi intervention; challenges or opportunities for improvement in paearahi model; change in confidence relating to injury prevention through intervention; paearahi training; injury and ACC related knowledge; whanau involvement; collective outcomes from the intervention; likelihood to utilise a similar programme in the future.
Timepoint [21] 403530 0
4-weeks post intervention completion.
Secondary outcome [22] 403531 0
Quantity of associated formal support (allied health, ACC, primary care) and informal support assessed using an electronic query of database with connectivity to paearahi records, locality records to other providers.
Timepoint [22] 403531 0
Monthly during intervention period.
Secondary outcome [23] 403532 0
Content of associated formal support (allied health, ACC, primary care) and informal support assessed using an electronic query of database with connectivity to paearahi records, locality records to other providers.
Timepoint [23] 403532 0
Monthly during intervention period.
Secondary outcome [24] 403533 0
Wellbeing score (as measured by the Hua Oranga tool)
Timepoint [24] 403533 0
12-weeks post-intervention (i.e 12-weeks post-first paearahi visit)

Eligibility
Key inclusion criteria
Community-dwelling
Maori (self-identified)
Aged 55 years or older
At 'high risk' of healthcare utilisation (has calculated from general practice prioritisaton tools embedded in patient management software).
Enrolled in one of the study general practices
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide informed consent AND/OR
• Living in an Aged Residential Care facility

Study design
Purpose of the study
Prevention
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2022
Actual
1/06/2022
Date of last participant enrolment
Anticipated
4/01/2023
Actual
31/12/2022
Date of last data collection
Anticipated
14/03/2024
Actual
30/06/2023
Sample size
Target
260
Accrual to date
Final
287
Recruitment outside Australia
Country [1] 24291 0
New Zealand
State/province [1] 24291 0

Funding & Sponsors
Funding source category [1] 309899 0
Government body
Name [1] 309899 0
Health Research Council of New Zealand
Country [1] 309899 0
New Zealand
Funding source category [2] 310072 0
Government body
Name [2] 310072 0
Accident Compensation Corporation of New Zealand
Country [2] 310072 0
New Zealand
Funding source category [3] 310073 0
Other
Name [3] 310073 0
National Sciences Challenge - Ageing Well
Country [3] 310073 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Faculty of Medicine and Health Sciences, Park Rd, Grafton, Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 311125 0
Charities/Societies/Foundations
Name [1] 311125 0
Te Arawa Whanau Ora Collective
Address [1] 311125 0
1231 Haupapa St, Rotorua, 3010
Country [1] 311125 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309621 0
Central Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 309621 0
Ethics committee country [1] 309621 0
New Zealand
Date submitted for ethics approval [1] 309621 0
05/11/2021
Approval date [1] 309621 0
25/01/2022
Ethics approval number [1] 309621 0
2022 FULL 11654

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

Contacts
Principal investigator
Name 114802 0
Dr Joanna Hikaka
Address 114802 0
Dept of General Practice and Primary Health Care
Faculty of Medicine and Health Sciences
Park Rd,
Grafton
Auckland, 1010
Country 114802 0
New Zealand
Phone 114802 0
+64 211304917
Fax 114802 0
Email 114802 0
j.hikaka@auckland.ac.nz
Contact person for public queries
Name 114803 0
Joanna Hikaka
Address 114803 0
Dept of General Practice and Primary Health Care
Faculty of Medicine and Health Sciences
Park Rd,
Grafton
Auckland, 1010
Country 114803 0
New Zealand
Phone 114803 0
+64 211304917
Fax 114803 0
Email 114803 0
j.hikaka@auckland.ac.nz
Contact person for scientific queries
Name 114804 0
Joanna Hikaka
Address 114804 0
Dept of General Practice and Primary Health Care
Faculty of Medicine and Health Sciences
Park Rd,
Grafton
Auckland, 1010
Country 114804 0
New Zealand
Phone 114804 0
+64 211304917
Fax 114804 0
Email 114804 0
j.hikaka@auckland.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
We are not seeking consent to allow this as we would not be able to guarantee Maori governance of the data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13929Study protocol    382936-(Uploaded-26-11-2021-09-55-46)-Study-related document.docx



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.