Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Implementation of CardioVascular Disease Risk Assessment by Pharmacy in secondary care for high-risk ethnicities
Query!
Secondary ID [1]
312509
0
Nil Known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CVD RAP
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease
334380
0
Query!
Condition category
Condition code
Cardiovascular
331018
331018
0
0
Query!
Coronary heart disease
Query!
Stroke
331019
331019
0
0
Query!
Ischaemic
Query!
Public Health
331086
331086
0
0
Query!
Health service research
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
329030
0
Early detection / Screening
Query!
Comparator / control treatment
No Control Group
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
338783
0
Number of study participants who have CVD RA completed by pharmacist in hospital.
Query!
Assessment method [1]
338783
0
An electronic note will be added to the patient's clinical record outlining completion of CVD RA. This data will be pulled from electronic records
Query!
Timepoint [1]
338783
0
Assessed 3 months after study implementation
Query!
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.
Query!
Assessment method [2]
338784
0
Data pulled from electronic clinical notes on specific pharmacy CVD RA form
Query!
Timepoint [2]
338784
0
Comparison of Health NZ CVD RA completion rates and the data assessed 3 months after study implementation
Query!
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
Query!
Assessment method [1]
437415
0
Data pulled from electronic clinical notes on specific pharmacy CVD RA form
Query!
Timepoint [1]
437415
0
Assessed 3 months after study implementation or when reached 200 participants enrolled.
Query!
Secondary outcome [2]
437416
0
Number of study participants on CVD preventative medications (statin) who have had these titrated if not meeting lipid targets.
Query!
Assessment method [2]
437416
0
Data pulled from electronic clinical notes on specific pharmacy CVD RA form
Query!
Timepoint [2]
437416
0
Assessed 3 months after study implementation or when reached 200 participants enrolled.
Query!
Secondary outcome [3]
437417
0
Number participants with newly identified diabetes or pre-diabetes.
Query!
Assessment method [3]
437417
0
Data pulled from electronic clinical notes on specific pharmacy CVD RA form
Query!
Timepoint [3]
437417
0
Assessed 3 months after study implementation or when reached 200 participants enrolled.
Query!
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)
Query!
Minimum age
30
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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%)
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
19/08/2024
Query!
Actual
11/09/2024
Query!
Date of last participant enrolment
Anticipated
11/12/2024
Query!
Actual
Query!
Date of last data collection
Anticipated
13/12/2024
Query!
Actual
Query!
Sample size
Target
200
Query!
Accrual to date
1
Query!
Final
Query!
Recruitment outside Australia
Country [1]
26419
0
New Zealand
Query!
State/province [1]
26419
0
Canterbury
Query!
Funding & Sponsors
Funding source category [1]
316933
0
Government body
Query!
Name [1]
316933
0
Health NZ - Waitaha Canterbury
Query!
Address [1]
316933
0
Query!
Country [1]
316933
0
New Zealand
Query!
Primary sponsor type
Hospital
Query!
Name
Christchurch Hospital Pharmacy Department
Query!
Address
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
319178
0
None
Query!
Name [1]
319178
0
Query!
Address [1]
319178
0
Query!
Country [1]
319178
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
315683
0
Southern Health and Disability Ethics Committee
Query!
Ethics committee address [1]
315683
0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Query!
Ethics committee country [1]
315683
0
New Zealand
Query!
Date submitted for ethics approval [1]
315683
0
01/12/2023
Query!
Approval date [1]
315683
0
11/06/2024
Query!
Ethics approval number [1]
315683
0
2024 FULL 18728
Query!
Summary
Brief summary
Up to a quarter of deaths from heart disease and strokes may be preventable through better preventative strategies and initiation of appropriate treatments. Mortality from cardiovascular disease is declining in NZ for all ethnicities as per the Health NZ report released early 2024, but Maori and Pacific people are still disproportionately affected. This provides rationale why cardiovascular disease risk assessment (CVD RA) is recommended 15 years earlier in Maori and Pacific people (and South Asian) compared to NZ Europeans. CVD RA is typically performed in primary care by GP practices in NZ. The Health NZ status report showed around 78% of eligible people were receiving CVD RA based on data from 2020/2021, but this data came with significant limitations. This completion rate is well below the target set by the Heart Foundation of 95 % of eligible New Zealanders having risk assessed and managed. Inpatient admission may provide opportunity for CVD RA to be performed in patients that have barriers to accessing primary care.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
135498
0
Mr Ev Tolerton
Query!
Address
135498
0
Christchurch Hospital Pharmacy, 2 Riccarton Avenue, Christchurch 8011
Query!
Country
135498
0
New Zealand
Query!
Phone
135498
0
+64 211948755
Query!
Fax
135498
0
Query!
Email
135498
0
[email protected]
Query!
Contact person for public queries
Name
135499
0
Ev Tolerton
Query!
Address
135499
0
Christchurch Hospital Pharmacy, 2 Riccarton Avenue, Christchurch 8011
Query!
Country
135499
0
New Zealand
Query!
Phone
135499
0
+64 03 3640640
Query!
Fax
135499
0
Query!
Email
135499
0
[email protected]
Query!
Contact person for scientific queries
Name
135500
0
Ev Tolerton
Query!
Address
135500
0
Christchurch Hospital Pharmacy, Christchurch Hospital, 2 Riccarton Avenue, Christchurch
Query!
Country
135500
0
New Zealand
Query!
Phone
135500
0
+64 03 3640640
Query!
Fax
135500
0
Query!
Email
135500
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF