Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001244695
Ethics application status
Approved
Date submitted
6/10/2023
Date registered
1/12/2023
Date last updated
1/12/2023
Date data sharing statement initially provided
1/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
SAFE-HF - tranSlating heArt Failure guidElines into practice in a Nurse Practitioner primary care service
Scientific title
SAFE-HF - tranSlating heArt Failure guidElines into practice: a RCT evaluating rehospitalisations and mortality in a Nurse Practitioner primary care service
Secondary ID [1] 309922 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SAFE-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 330400 0
Condition category
Condition code
Cardiovascular 327240 327240 0 0
Other cardiovascular diseases
Public Health 328602 328602 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to usual care, the patient will be seen face-to-face with a heart failure nurse practitioner in their local GP primary care practice. They will be seen weekly for 12 weeks commencing in the first week post-discharge. The purpose of the review by the heart failure nurse practitioner is to prescribe and titrate medications (such as beta-blockers, angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), angiotensin receptor neprilsyn inhibitor (ARNI), mineralocorticoid receptor antagonist (MRA), sodium-glucose cotransporter 2 inhibitor (SGLT2i) and provide education about heart failure based on the Heart Foundation Heart Failure patient resource. Education topics include: what is heart failure, self-management of heart failure at home and lifestyle modifications. The education sessions will be face-to-face utilising the Heart Foundation resource and their education videos.
The consultation review protocol is designed specifically for this study
Each consultation will take 30 minutes and collect data about the treatment and management plans implemented during the consultations.
Intervention code [1] 327159 0
Treatment: Drugs
Intervention code [2] 327160 0
Behaviour
Comparator / control treatment
This is a pragmatic randomised controlled trial so the usual care group will receive usual care which is no review with a heart failure nurse practitioner. Follow up post discharge will be as organised by hospital staff and primary care practice.
Control group
Active

Outcomes
Primary outcome [1] 336282 0
All-cause rehospitalisations collected via electronic medical records
Timepoint [1] 336282 0
Six months from the time of discharge
Primary outcome [2] 336283 0
All-cause mortality collected via electronic medical records
Timepoint [2] 336283 0
Six months from the time of discharge
Secondary outcome [1] 427655 0
Mean change in quality of life measured by Kanzas City Cardiomyopathy Questionnaire (KCCQ)
Timepoint [1] 427655 0
At the first nurse practitioner clinic visit (in the first week post-discharge) and at six months from the time of discharge
Secondary outcome [2] 427656 0
Mean change in self-care management measured by European Heart Failure Self-care Behaviour Scale (EHFScB-9)
Timepoint [2] 427656 0
At the first nurse practitioner clinic visit (in the first week post-discharge) and at six months from the time of discharge
Secondary outcome [3] 427657 0
Received an appointment in primary care with the heart failure nurse practitioner within one week of discharge and was prescribed the following medications: beta-blockers, angiotensin converting enzyme inhibitors/angiotensin receptor blockers /angiotensin receptor neprilysin inhibitors, SGLT2 inhibitors and/or mineralocorticoid receptor antagonists
Timepoint [3] 427657 0
Six months from the time of discharge via data collected in primary care
Secondary outcome [4] 429051 0
Mean change in quality of life measured by Australian Quality of Life (AQoL) survey
Timepoint [4] 429051 0
At the first nurse practitioner clinic visit (in the first week post-discharge) and at six months from the time of discharge

Eligibility
Key inclusion criteria
Patients hospitalised with heart failure and being discharged home, confirmed diagnosis of heart failure based on echocardiography, aged 18 years and over, living within the catchment area of participating health services, and not receiving palliative care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients discharged to an aged care facility or palliative care or patients not residing in the catchment area of their local health service

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)
Randomisation will be embedded in RedCap, concealed to study personnel. Once the patient has consented to participate in the trial, the site research coordinator will contact the project manager to find out which group the patient is randomly allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (RedCap).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2024
Actual
Date of last participant enrolment
Anticipated
10/01/2025
Actual
Date of last data collection
Anticipated
10/07/2025
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314104 0
Government body
Name [1] 314104 0
Commonwealth Department of Health, NHMRC -Medical Research Future Fund
Country [1] 314104 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Burwood Highway, Burwood, Victoria 3125
Country
Australia
Secondary sponsor category [1] 316986 0
None
Name [1] 316986 0
Address [1] 316986 0
Country [1] 316986 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313244 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 313244 0
Ethics committee country [1] 313244 0
Australia
Date submitted for ethics approval [1] 313244 0
04/07/2023
Approval date [1] 313244 0
04/09/2023
Ethics approval number [1] 313244 0

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

Contacts
Principal investigator
Name 127458 0
Prof Andrea Driscoll
Address 127458 0
Deakin University, School of Nursing and Midwifery, 225 Burwood Hwy, Burwood VIC 3125
Country 127458 0
Australia
Phone 127458 0
+61 03 92517212
Fax 127458 0
Email 127458 0
andrea.driscoll@deakin.edu.au
Contact person for public queries
Name 127459 0
Andrea Driscoll
Address 127459 0
Deakin University, School of Nursing and Midwifery, 225 Burwood Hwy, Burwood VIC 3125
Country 127459 0
Australia
Phone 127459 0
+61 03 92517212
Fax 127459 0
Email 127459 0
andrea.driscoll@deakin.edu.au
Contact person for scientific queries
Name 127460 0
Andrea Driscoll
Address 127460 0
Deakin University, School of Nursing and Midwifery, 225 Burwood Hwy, Burwood VIC 3125
Country 127460 0
Australia
Phone 127460 0
+61 03 92517212
Fax 127460 0
Email 127460 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
I do not have ethics approval to share the data


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.