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Trial registered on ANZCTR


Registration number
ACTRN12624000920594
Ethics application status
Approved
Date submitted
11/07/2024
Date registered
30/07/2024
Date last updated
15/09/2024
Date data sharing statement initially provided
30/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Heart Health check for Maori and Pacific People in Hospital
Scientific title
Implementation of CardioVascular Disease Risk Assessment by Pharmacy in secondary care for high-risk ethnicities
Secondary ID [1] 312509 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
CVD RAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 334380 0
Condition category
Condition code
Cardiovascular 331018 331018 0 0
Coronary heart disease
Stroke 331019 331019 0 0
Ischaemic
Public Health 331086 331086 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A study trained Pharmacist at Christchurch public hospital will offer Cardiovascular Disease Risk Assessment to Maori and Pacific inpatients who meet the NZ Ministry of Health 2018 Guidelines criteria for risk assessment, but for whom it has not been provided.

Study Pharmacists performing the intervention will be clinically and cultural trained to perform Cardiovascular Disease Risk Assessment in Maori and Pacific People. After consent is gained, the study pharmacist will take a history and ask hospital team to add additional blood tests (lipids, Hba1c and renal function) if needed.

The intervention will be offered once only to participants who met study inclusion/exclusion criteria.

Risk Assessment will be undertaken in the hospital using PREDICT based tools available publicly on the internet.
Either:
https://decisionaid.ca/cvd/
https://www.nzssd.org.nz/cvd/
https://www.heartfoundation.org.nz/your-heart/my-heart-check

Calculation of CVD risk will occur when lab results are back (possibly the day after consenting) and likely done remotely from patient. The study pharmacist will then discuss results and management options with the participant (which is expected to take between 30 minutes and 1 hour including calculating of risk when all data is collected). Ideally the same study pharmacist will perform all of consent, risk assessment and management discussions but this may need to be done by different staff.

Lifestyle (smoking cessation if applicable, physical activity) and dietary advice will be provided to all participants using standard NZ Heart Foundation resources. Higher risk participants will be offered lipid lowering therapy most likely with statins (and educated on risks/benefits using patient information leaflet from mymedicines.nz) and handed over to primary care for ongoing management. Communication will be primarily through the discharge summary, but a phone call to primary care will take place for some patients. If no primary care provider currently, they can be referred to social work services to facilitate engagement with a primary care provider post discharge. Participants adherence to management will not be followed up post discharge.
Intervention code [1] 329030 0
Early detection / Screening
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338783 0
Number of study participants who have CVD RA completed by pharmacist in hospital.
Timepoint [1] 338783 0
Assessed 3 months after study implementation
Primary outcome [2] 338784 0
To calculate the proportion of eligible Maori and Pacific people who have received a CVD RA before and after this intervention in Christchurch.
Timepoint [2] 338784 0
Comparison of Health NZ CVD RA completion rates and the data assessed 3 months after study implementation
Secondary outcome [1] 437415 0
Proportion of study participants with Intermediate or High risk (or equivalent risk) of CVD agreeable to starting a statin at discharge
Timepoint [1] 437415 0
Assessed 3 months after study implementation or when reached 200 participants enrolled.
Secondary outcome [2] 437416 0
Number of study participants on CVD preventative medications (statin) who have had these titrated if not meeting lipid targets.
Timepoint [2] 437416 0
Assessed 3 months after study implementation or when reached 200 participants enrolled.
Secondary outcome [3] 437417 0
Number participants with newly identified diabetes or pre-diabetes.
Timepoint [3] 437417 0
Assessed 3 months after study implementation or when reached 200 participants enrolled.

Eligibility
Key inclusion criteria
o Maori or Pacific Male* aged 30 or above
o Maori or Pacific Female* aged 40 or above
o Live in greater Christchurch area to ensure appropriate community follow up can be arranged.

(*Sex at birth)
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High risk CVD features that automatically define risk as > 15%
o Heart failure
o Coronary or carotid artery disease from imaging (unlikely to have in community)
o eGFR < 30 mL/min or < 45mL/min with diabetes
o Previous Cardiovascular event
o Familial hypercholesterolaemia

o Age greater than 75 (as the PREDICT CVD RA tool is only validated for < 75 years)
o Pregnant / Breastfeeding
o Not appropriate due to clinical or emotional status (too unwell) or prognosis (short life expectancy)
Note: If deemed inappropriate due to current clinical status, this can be reassessed at a later date during their admission
o Patient had CVD RA completed previously + clearly recalls their risk level AND is not due to repeat assessment (see below) AND appears appropriately treated for risk level.
Note: Due to variance in completion rates / quality / timeliness and patient recall of previous CVD RA – better to assess again if any concerns to appropriately manage cardio-vascular disease risk.

Recommended interval for repeat CVD risk assessment
Risk < 3% – ten years
Risk 3–9% – five years
Risk 10–14% – two years
Risk = 15% – one year
Risk 5–15% and prescribed pharmacological interventions – one year
Severe mental illness – two years (or one year if risk greater than or equal to 15%)

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
The Health NZ report outlined with limited data that on average 78 % of the eligible population had CVD RA completed. Although this was as low as 62.5 % for Pacific people in Te Waipounamu which encompasses Christchurch. Due to the inconsistent data, regional variations, and non-mandatory reporting of CVD RA data it is difficult to determine the true effect size. We are aiming to recruit 200 participants into the study over 3 months based on an estimated effect size of 0.2 of eligible people who have not had their CVD RA completed (Effect size 0.2, Sig.level 0.05, Power 0.80, Type of tail Two-sided N 197). However, if we determine through in-study analysis that the effect size is larger then we will stop recruiting participants earlier.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/08/2024
Actual
11/09/2024
Date of last participant enrolment
Anticipated
11/12/2024
Actual
Date of last data collection
Anticipated
13/12/2024
Actual
Sample size
Target
200
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 26419 0
New Zealand
State/province [1] 26419 0
Canterbury

Funding & Sponsors
Funding source category [1] 316933 0
Government body
Name [1] 316933 0
Health NZ - Waitaha Canterbury
Country [1] 316933 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch Hospital Pharmacy Department
Address
Country
New Zealand
Secondary sponsor category [1] 319178 0
None
Name [1] 319178 0
Address [1] 319178 0
Country [1] 319178 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315683 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315683 0
Ethics committee country [1] 315683 0
New Zealand
Date submitted for ethics approval [1] 315683 0
01/12/2023
Approval date [1] 315683 0
11/06/2024
Ethics approval number [1] 315683 0
2024 FULL 18728

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

Contacts
Principal investigator
Name 135498 0
Mr Ev Tolerton
Address 135498 0
Christchurch Hospital Pharmacy, 2 Riccarton Avenue, Christchurch 8011
Country 135498 0
New Zealand
Phone 135498 0
+64 211948755
Fax 135498 0
Email 135498 0
[email protected]
Contact person for public queries
Name 135499 0
Ev Tolerton
Address 135499 0
Christchurch Hospital Pharmacy, 2 Riccarton Avenue, Christchurch 8011
Country 135499 0
New Zealand
Phone 135499 0
+64 03 3640640
Fax 135499 0
Email 135499 0
[email protected]
Contact person for scientific queries
Name 135500 0
Ev Tolerton
Address 135500 0
Christchurch Hospital Pharmacy, Christchurch Hospital, 2 Riccarton Avenue, Christchurch
Country 135500 0
New Zealand
Phone 135500 0
+64 03 3640640
Fax 135500 0
Email 135500 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.