Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000947808
Ethics application status
Approved
Date submitted
4/06/2021
Date registered
20/07/2021
Date last updated
8/08/2022
Date data sharing statement initially provided
20/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Safe Treatment of Atrial fibrillation in the communitY (STAY): A feasibility study
Scientific title
Safe Treatment of Atrial fibrillation in the communitY (STAY): A feasibility trial investigating a new model of community-based care for atrial fibrillation patients with low-risk acute presentations accessing emergency services
Secondary ID [1] 304385 0
None
Universal Trial Number (UTN)
Trial acronym
STAY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 322195 0
Condition category
Condition code
Cardiovascular 319884 319884 0 0
Other cardiovascular diseases
Public Health 319886 319886 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Atrial fibrillation (AF) patients (diagnosed by electrocardiogram (ECG), confirmed by study on-call cardiologist) will undergo a clinical risk assessment (specifically designed for this study) by ambulance paramedics. The intervention will be made available to patients identified as ‘low-risk’ only. Low-risk patients are defined as having none of the following: syncope, clinical heart failure, hypoxia, ischaemic chest pain, SBP<100 mmHg, active bleeding or severe symptoms. Low-risk patients will receive a single dose of oral beta blocker, metoprolol 50mg, and single dose of oral anticoagulant, rivaroxaban 15mg, by ambulance paramedics. Patients are to be left at home for community management. The specialist AF clinic will contact the patient within 48 hours of ambulance attendance to organise tele-health or in-person appointment (as required). Trial participation will be voluntary; low-risk patients may refuse alternative care and receive standard care.
Intervention code [1] 320758 0
Treatment: Other
Intervention code [2] 321194 0
Treatment: Drugs
Comparator / control treatment
Patients identified as 'high-risk', using the clinical risk assessment tool, will receive standard care and act as a comparator group. Standard care involves ambulance transportation to the emergency department (ED), where patients may be referred to specialist AF clinics through this pathway.

Patients identified as 'low-risk' who opt out of the intervention and choose to receive standard care will form another comparator group for analysis.
Control group
Active

Outcomes
Primary outcome [1] 327763 0
The principle efficacy endpoint is the delay to clinic attendance for community based care versus standard care (transfer to hospital). This will be assessed through audit of ambulance patient care records, and clinic medical records.
Timepoint [1] 327763 0
At the interim analysis (halfway through the study, n=200) and conclusion of the study.
Secondary outcome [1] 396511 0
Feasibility will be assessed by the proportion of patients at low risk (as determined using the clinical risk assessment tool, designed specifically for the study).
Timepoint [1] 396511 0
At the conclusion of the study.
Secondary outcome [2] 396516 0
Acceptability of alternative model of care using a Net Promotor Score (1-10). Acceptability will be defined as a Net Promotor Score > 60%.
- How satisfied are you with your care?
Timepoint [2] 396516 0
Assessed at the time of specialist AF clinic attendance.
Secondary outcome [3] 396517 0
Risk of thromboembolism as assessed by the CHA2DS2-VASc score.
Timepoint [3] 396517 0
Assessed at the specialist AF clinic attendance.
Secondary outcome [4] 396523 0
Proportion of patients experiencing metoprolol intolerance. This will be assessed by audit of ambulance records and clinic medical records.
Timepoint [4] 396523 0
At the interim analysis (halfway through the study, n=200) and conclusion of the study.
Secondary outcome [5] 397634 0
Proportion of patients experiencing serious or non-life threatening major bleeding after administration of rivaroxaban .This will be assessed by audit of ambulance records and clinic medical records.
Timepoint [5] 397634 0
At the interim analysis (halfway through the study, n=200) and conclusion of the study.
Secondary outcome [6] 397766 0
Risk of bleeding as assessed by the HAS-BLED score.
Timepoint [6] 397766 0
Assessed at the time of the specialist AF clinic attendance.
Secondary outcome [7] 398489 0
Feasibility will be assessed by the proportion of low risk patients not proceeding to hospital transfer. This will be assessed by audit of ambulance records.
Timepoint [7] 398489 0
At the conclusion of the study
Secondary outcome [8] 398491 0
Feasibility will be assessed by the proportion of patients proceeding directly from paramedic contact to AF clinic. This will be assessed by audit of ambulance records and clinic medical records.
Timepoint [8] 398491 0
At the conclusion of the study
Secondary outcome [9] 398492 0
Feasibility will be assessed by the proportion of patients requiring re-attendance by ambulance prior to clinic attendance. This will be assessed by audit of ambulance records.
Timepoint [9] 398492 0
At the conclusion of the study.
Secondary outcome [10] 398494 0
Feasibility will be assessed by the proportion of patients opting out of the new care pathway. This will be assessed by audit of ambulance records.
Timepoint [10] 398494 0
At the conclusion of the study.

Eligibility
Key inclusion criteria
Adults (18 years of age and over)
Atrial fibrillation diagnosis (identified with ECG and confirmed by study on-call cardiologist)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not reside in the Melbourne Metropolitan area

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The target population will comprise all patients contacting paramedics with acute symptoms and AF, therefore the project aims to recruit 600 participants (100 from each site). The study will commence at one hospital site, (Austin Hospital) before rolling out gradually to other sites.

The feasibility design focuses only on individuals who have experienced the event of interest (AF) and offers a high level of internal validity. The study design with broad inclusion criteria and pre-specified exclusion criteria will produce results with high external validity. The large sample size which approximates 5-10% of Ambulance Victoria’s annual AF case volume (600 of 6,500) will make results generalisable.

Low risk (inclusion) criteria will define a subset of patients who receive community care. Those not at low risk (meeting exclusion criteria) will be transferred to hospital. Those at low risk but with a preference for hospital care will form a third group. Enrolment will be continued until the sample size is achieved. Those not attending clinics will form a fourth group for analysis. Descriptive statistics will be presented as frequencies and proportions, with comparisons across groups using the chi square test. Statistical significance will be defined as p<0.05 two tailed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
16/12/2021
Date of last participant enrolment
Anticipated
20/11/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308756 0
Government body
Name [1] 308756 0
Ambulance Victoria
Country [1] 308756 0
Australia
Primary sponsor type
Government body
Name
Ambulance Victoria
Address
31 Joseph St
Blackburn North VIC 3130
Country
Australia
Secondary sponsor category [1] 309678 0
None
Name [1] 309678 0
Address [1] 309678 0
Country [1] 309678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308673 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 308673 0
Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
Ethics committee country [1] 308673 0
Australia
Date submitted for ethics approval [1] 308673 0
26/10/2020
Approval date [1] 308673 0
05/07/2021
Ethics approval number [1] 308673 0

Summary
Brief summary
The study aims to evaluate feasibility, safety and acceptability of an integrated community-based model-of-care for low risk patients with AF and to gather data that will allow this new model-of-care to be implemented system-wide. The research hypothesis is that it is feasible for Ambulance Victoria and specialist AF clinics to deliver an integrated safe and timely community-based model-of-care for AF patients with low risk acute presentations. By implementing a novel clinical pathway supported by cardiology consultation, paramedics can accurately and safely treat AF in the homes, avoiding the need for transport to ED.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111510 0
Prof Karen Smith
Address 111510 0
Ambulance Victoria
31 Joseph St
Blackburn North VIC 3130
Country 111510 0
Australia
Phone 111510 0
+61 3 9896 6083
Fax 111510 0
Email 111510 0
karen.smith@ambulance.vic.gov.au
Contact person for public queries
Name 111511 0
Prof Karen Smith
Address 111511 0
Ambulance Victoria
31 Joseph St
Blackburn North VIC 3130
Country 111511 0
Australia
Phone 111511 0
+61 3 9896 6083
Fax 111511 0
Email 111511 0
karen.smith@ambulance.vic.gov.au
Contact person for scientific queries
Name 111512 0
Dr Jocasta Ball
Address 111512 0
Ambulance Victoria
31 Joseph St
Blackburn North 3130 VIC
Country 111512 0
Australia
Phone 111512 0
+61 3 9896 6215
Fax 111512 0
Email 111512 0
jocasta.ball@ambulance.vic.gov.au

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.