Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001353886
Ethics application status
Approved
Date submitted
17/08/2021
Date registered
7/10/2021
Date last updated
7/10/2023
Date data sharing statement initially provided
7/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
I-HEART: Implementation of HEArt failure guidelines for patients with acute heart failure in Regional AusTralia
Scientific title
I-HEART: Implementation of HEArt failure guidelines for patients with acute heart failure in Regional AusTralia
Secondary ID [1] 305074 0
Nil known
Universal Trial Number (UTN)
Trial acronym
I-HEART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 323293 0
Condition category
Condition code
Cardiovascular 320859 320859 0 0
Coronary heart disease
Public Health 321120 321120 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered by telehealth between specialists in a metropolitan health service and health professionals in a regional health service
1) One appointment of one hour telehealth review by a heart failure (HF) Cardiologist (from a metropolitan hospital) with the patient and their regional site Dr/GP by day 10 post-discharge, and 2) five appointments each of one hour telehealth reviews by a HF nurse practitioner from a metropolitan hospital, in conjunction with the regional site community outreach nurse and patient by day five and then weekly for 28 days post-discharge
The purpose of the review by the HF Cardiologist is to review the HF patients post-discharge and to develop a management plan with the patient and their local Dr/GP.
The purpose of the review by the HF nurse practitioner is to prescribe and titrate medications and provide education about HF based on the Heart Foundation HF patient resource.
The telehealth review protocol is designed specifically for this study
No training is required by the cardiologist and nurse practitioner as both are qualified and experts in the field. Each telehealth consultation will collect data about the treatment and management plans implemented during the consultations. These consultations will not be recorded.
Intervention code [1] 321471 0
Treatment: Other
Intervention code [2] 321676 0
Treatment: Drugs
Intervention code [3] 321677 0
Treatment: Devices
Comparator / control treatment
The stepped wedge randomised controlled trial will require randomisation to the intervention of two health services at a time each for a duration of nine months.
The control group will receive usual care which is no review or telehealth review with a cardiologist or heart failure nurse practitioner. Follow up post discharge will be as organised by hospital staff.
Control group
Active

Outcomes
Primary outcome [1] 328650 0
Composite outcome of all-cause rehospitalisations and all-cause mortality at 12 months from the time of discharge. This will be collected by data linkage with hospital medical records
Timepoint [1] 328650 0
12 months post-discharge
Secondary outcome [1] 399829 0
The patient received a telehealth visit from a HF nurse practitioner with the local community outreach service within five days of discharge. This will be collected during the telehealth visit
Timepoint [1] 399829 0
5 days post-discharge
Secondary outcome [2] 399830 0
The patient received a telehealth visit from a Cardiologist within 10 days of discharge. This will be collected during the telehealth visit
Timepoint [2] 399830 0
10 days post-discharge
Secondary outcome [3] 400826 0
Composite outcome if the patient was prescribed, when medically indicated, beta-blockers, angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or angiotensin receptor neprilysin inhibitors (ARNIs); and mineralocorticoid receptor antagonists (MRAs). This will be collected from medical records and telehealth clinic notes.
Timepoint [3] 400826 0
30 days post-discharge

Eligibility
Key inclusion criteria
All patients admitted to the regional health service with acute heart failure, aged over 17 years, who are discharged alive and not transferred to palliative care or another hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Allocation was stratified based on the size of the health service. At each step one large and one small health service were randomised. Sites were randomised to sequence of implementation in step 1, 2, or 3.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a stepped wedge cluster randomised trial. The unit of randomisation is the health service
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
These will be conducted on an intention-to-treat basis. A generalized estimating equation approach, logit link and binomial distribution, will be used to compare the primary and secondary outcomes between intervention and usual care periods. The covariance matrix will account for clustering induced by the sites and by patients contributing with multiple admissions. A biostatistician is responsible for the statistical analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/10/2021
Actual
9/11/2022
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
2/12/2024
Actual
Sample size
Target
6000
Accrual to date
1000
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 20291 0
Swan Hill District Health - Swan Hill
Recruitment hospital [2] 20292 0
Castlemaine Health - Castlemaine
Recruitment hospital [3] 20293 0
Albury Wodonga Health - Wodonga campus - Wodonga
Recruitment hospital [4] 20294 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [5] 20295 0
East Grampians Health Service - Ararat - Ararat
Recruitment hospital [6] 20296 0
Colac Area Health - Colac
Recruitment hospital [7] 20297 0
Southwest Health Care - Warrnambool - Warrnambool
Recruitment postcode(s) [1] 35032 0
3585 - Swan Hill
Recruitment postcode(s) [2] 35033 0
3450 - Castlemaine
Recruitment postcode(s) [3] 35034 0
3690 - Wodonga
Recruitment postcode(s) [4] 35035 0
2640 - Albury
Recruitment postcode(s) [5] 35036 0
3377 - Ararat
Recruitment postcode(s) [6] 35037 0
3250 - Colac
Recruitment postcode(s) [7] 35038 0
3280 - Warrnambool

Funding & Sponsors
Funding source category [1] 309474 0
Government body
Name [1] 309474 0
NHMRC
Country [1] 309474 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
225 Burwood Hwy, Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 310444 0
None
Name [1] 310444 0
Address [1] 310444 0
Country [1] 310444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309261 0
Austin Health Human Research Ethics committee
Ethics committee address [1] 309261 0
Ethics committee country [1] 309261 0
Australia
Date submitted for ethics approval [1] 309261 0
03/08/2021
Approval date [1] 309261 0
07/10/2021
Ethics approval number [1] 309261 0

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

Contacts
Principal investigator
Name 113534 0
Prof Andrea Driscoll
Address 113534 0
Deakin University, School of Nursing and Midwifery, 225 Burwood Hwy, Burwood VIC 3125
Country 113534 0
Australia
Phone 113534 0
+61 03 92517212
Fax 113534 0
Email 113534 0
andrea.driscoll@deakin.edu.au
Contact person for public queries
Name 113535 0
Andrea Driscoll
Address 113535 0
Deakin University, School of Nursing and Midwifery, 225 Burwood Hwy, Burwood VIC 3125
Country 113535 0
Australia
Phone 113535 0
+61 03 92517212
Fax 113535 0
Email 113535 0
andrea.driscoll@deakin.edu.au
Contact person for scientific queries
Name 113536 0
Andrea Driscoll
Address 113536 0
Deakin University, School of Nursing and Midwifery, 225 Burwood Hwy, Burwood VIC 3125
Country 113536 0
Australia
Phone 113536 0
+61 03 92517212
Fax 113536 0
Email 113536 0
andrea.driscoll@deakin.edu.au

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 unable to share IPD as it has not been approved by the ethics committee


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.