Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001466831
Ethics application status
Approved
Date submitted
16/08/2021
Date registered
27/10/2021
Date last updated
25/08/2023
Date data sharing statement initially provided
27/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of an emergency department protocol and early outpatient follow up in a specialised clinic for atrial fibrillation
Scientific title
Redesigning care with an Emergency Department protocol and rapid access clinic: Can this reduce hospitalisations for Atrial Fibrillation?
Secondary ID [1] 304945 0
None
Universal Trial Number (UTN)
Trial acronym
REDUCE AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 323097 0
Condition category
Condition code
Cardiovascular 320674 320674 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two components to the intervention:
1. An emergency department protocol for the management of atrial fibrillation (AF). This protocol will aim to guide emergency department clinicians in the acute management of AF to standardise care delivery, provide appropriate anticoagulation to reduce stroke risk and written advice for patients on management of the current or recurrent episodes of AF.
This emergency department protocol has been developed by a multidisciplinary team including electrophysiologists, emergency department physicians, emergency department nurses and specialist atrial fibrillation nurses. The protocol has been presented and refined following presentation to a specialist group of electrophysiology researchers (Centre for Heart Rhythm Disorders) and the emergency department team at the Royal Adelaide Hospital. The protocol will be evaluated at the same time as the rapid access AF clinic, as this clinic is an integral part of the protocol.
2. All intervention participants will be asked to return to the hospital within 24-72 hours from their emergency department presentation to attend a rapid access AF clinic. This clinic will be staffed by a specialist cardiology nurse and electrophysiology fellow or consultant. The nurse will receive training in the use of structured educational visiting, a technique designed to educate and empower the patient with use of key messages deemed essential to facilitate self management of their condition. Delivery of this education will be supported by a validated written patient resource, Living Well with Atrial Fibrillation. This resource was previously developed and evaluated in another research study undertaken by our group (Home Based Education and Learning Program for Atrial Fibrillation) and was published in 2019. In addition to this education, other care provided in this clinic will include referral for electrical cardioversion (if required), referral for other investigations in these have not been performed in the last 12 months, including holter monitoring, echocardiography, blood testing and exercise stress testing and provision of advice for the future management of AF episodes. The appropriate use of medication to manage AF, including oral anticoagulation to manage stroke risk and rate and rhythm controlling agents will be prescribed as required. Relevant comorbidity management will also be assessed with referral to other healthcare professionals permitted if indicated. This initial visit will be followed up by one follow up visit four to six weeks later to re-enforce education provided and review any test results. The initial visit is expected to last for 60-90 minutes with the second visit expected to take 30-60 minutes. Following this second visit, care will be returned to the treating General Practitioner and Cardiologist. A letter will be sent to the General Practitioner and Cardiologist summarising each visit. If patients re-present to hospital with atrial fibrillation or flutter over follow up, they will be managed with the emergency department protocol if they meet the inclusion and exclusion criteria. One extra follow up visit will be undertaken in the rapid access AF clinic to address any potentially modifiable factors associated with repeat hospital presentations. This will be scheduled to occur within 24-72 hours as per the standard protocol.
Adherence to the protocol will be evaluated through audit of medical records. This will be recorded in the research database. Adherence to the rapid access AF clinic protocol will be ensured through practitioner training and oversight by senior research members. A checklist will be utilised in the research database to ensure that all required clinic components are adhered to.
Intervention code [1] 321343 0
Treatment: Other
Comparator / control treatment
There will be two comparators in this study, to ensure appropriate evaluation of the impact of this model of care delivery:

1. Flinders Medical Centre (FMC). FMC is a large tertiary referral centre in South Australia of similar size to the Royal Adelaide Hospital. This site will act as a control site, where all participants will receive care as usual. Coding data from this hospital will be used to identify all emergency department presentations with atrial fibrillation and a combination of the electronic health record (in all participants) and phone interviews and questionnaires (in participants who consent) will determine study outcomes over follow up. Referrals will occur at the discretion of the treating healthcare professionals. There is currently no specific education program in place for individuals at this hospital.

2. Information concerning presentation to the emergency department of the Royal Adelaide Hospital and Flinders Medical Centre with atrial fibrillation or flutter for the 12 months preceding commencement of the intervention will be obtained and compared to outcomes observed over the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 328496 0
Incidence rate ratio of unplanned hospital admissions for cardiovascular causes (AF and non-AF related) over follow-up. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [1] 328496 0
12 months from, and inclusive of index presentation
Secondary outcome [1] 399184 0
Incidence rate ratio of unplanned hospital admissions for cardiovascular causes (AF and non-AF related) over follow-up. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [1] 399184 0
12 months from, and inclusive of index presentation
Secondary outcome [2] 399185 0
Incidence rate ratio of unplanned hospital admissions for other (non-AF) cardiovascular causes over follow-up. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [2] 399185 0
12 months from index presentation
Secondary outcome [3] 399186 0
Incidence rate ratio of unplanned hospital admissions for non-cardiovascular causes over follow-up. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [3] 399186 0
12 months from index presentation
Secondary outcome [4] 399187 0
Incidence rate ratio of emergency department presentations for atrial fibrillation over follow-up. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [4] 399187 0
12 months from index presentation.
Secondary outcome [5] 399188 0
Incidence rate ratio of emergency department presentations for other (non-AF) cardiovascular causes over follow-up. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [5] 399188 0
12 months from index presentation
Secondary outcome [6] 399189 0
Incidence rate ratio of emergency department presentations for non-cardiovascular causes over follow-up. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [6] 399189 0
12 months from index presentation
Secondary outcome [7] 399190 0
General health related quality of life, as assessed by the SF-36
Timepoint [7] 399190 0
Assessed at baseline, 3 months, 6 months and 12 months from index presentation.
Secondary outcome [8] 399191 0
AF symptom severity, as assessed by the Atrial Fibrillation Symptom Severity Questionnaire
Timepoint [8] 399191 0
Assessed at baseline, 3 months, 6 months and 12 months from index presentation.
Secondary outcome [9] 399192 0
Disease specific quality of life, as assessed by the Atrial Fibrillation Effect on Quality of Life Questionnaire
Timepoint [9] 399192 0
Assessed at baseline, 3 months, 6 months and 12 months from index presentation.
Secondary outcome [10] 399193 0
AF knowledge, as assessed by the Atrial Fibrillation Knowledge Questionnaire
Timepoint [10] 399193 0
Assessed at baseline, 3 months and 12 months from index presentation.
Secondary outcome [11] 399194 0
Guideline adherent prescription of oral anticoagulation. This will be assessed via telephone calls to participants.
Timepoint [11] 399194 0
Assessed at baseline, 3 months and 12 months from index presentation.
Secondary outcome [12] 399195 0
All cause mortality
Timepoint [12] 399195 0
Any mortality recorded during 12 months of follow up from index presentation.
Secondary outcome [13] 399196 0
Duration of time spent in the emergency department at index presentation for AF. This will be assessed through medical record review.
Timepoint [13] 399196 0
Time spent in the emergency department at index presentation for AF.
Secondary outcome [14] 399197 0
Cost-effectiveness. This will be assessed by calculation of quality adjusted life years.
Timepoint [14] 399197 0
Over 12 months of follow up from index presentation.
Secondary outcome [15] 401676 0
Incidence rate ratio of emergency department presentations for cardiovascular causes (AF and non-AF) over follow-up. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [15] 401676 0
12 months from index presentation
Secondary outcome [16] 401677 0
Hospitalization rate for AF at index presentation - This will be assessed by telephone calls to the participants and review of medical records
Timepoint [16] 401677 0
12 months from index presentation.
Secondary outcome [17] 401678 0
Time to first unplanned hospital admission for AF. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [17] 401678 0
12 months from index presentation
Secondary outcome [18] 401679 0
Time to first unplanned hospital admission for other (non-AF) cardiovascular causes. This will be assessed by two mechanisms: telephone calls to participants and review of medical records
Timepoint [18] 401679 0
12 months from index presentation
Secondary outcome [19] 401681 0
Time to first unplanned hospital admission for non-cardiovascular causes. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [19] 401681 0
12 months from index presentation
Secondary outcome [20] 401682 0
Time to first unplanned hospital admission for cardiovascular causes (AF and non-AF). This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [20] 401682 0
12 months from index presentation
Secondary outcome [21] 425975 0
Time to first emergency department presentation re-presentation for AF. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [21] 425975 0
12 months from index presentation
Secondary outcome [22] 425976 0
Time to first emergency department presentation for other (non-AF) cardiovascular causes. This will be assessed by two mechanisms: telephone calls to participants and review of medical records
Timepoint [22] 425976 0
12 months from index presentation
Secondary outcome [23] 425977 0
Time to first emergency department presentation for non-cardiovascular causes. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [23] 425977 0
12 months from index presentation
Secondary outcome [24] 425978 0
Time to first emergency department presentation re-presentation for cardiovascular causes (AF and non-AF). This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [24] 425978 0
12 months from index presentation
Secondary outcome [25] 425979 0
Incidence rate ratio of planned hospital admissions for AF. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [25] 425979 0
12 months from index presentation.
Secondary outcome [26] 425980 0
Incidence rate ratio of planned hospital admissions for other (non-AF) cardiovascular causes. This will be assessed by two mechanisms: telephone calls to participants and review of medical records.
Timepoint [26] 425980 0
12 months from index presentation
Secondary outcome [27] 425981 0
Duration of time spent in the emergency department at any repeat emergency department presentation for AF over follow up. This will be assessed through medical record review
Timepoint [27] 425981 0
12 months from index presentation

Eligibility
Key inclusion criteria
• All individuals aged 18 years of age or older and 90 years of age or younger presenting to the emergency department predominantly due to AF
• AF or atrial flutter documented on ECG or rhythm strip during hospital presentation
• Living independently
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age less than 18 years and greater than 90 years of age
• Absence of ECG documentation of AF during index presentation

• Acute heart failure or acute coronary syndrome on index presentation to ED with AF
• Documented thyrotoxicosis or acute pneumonia at index presentation
• Known left ventricular ejection fraction <35%
• Complex congenital heart disease and patients with Wolff-Parkinson-White syndrome
• Cardiac surgery < 2 months prior to index presentation
• Patients with a terminal malignancy or any condition with <12months life expectancy

• Stage IV or V chronic kidney disease/dialysis (ie eGFR < 30 mL/min)
• Pregnancy
• Poor English literacy
• Non-independent living
• Inability to provide informed consent

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study will be carried out as a cluster controlled study. All participants at the Royal Adelaide Hospital will receive the intervention and all participants at Flinders Medical Centre will receive care as usual.

Outcomes will also be assessed using a historical control group from the Royal Adelaide Hospital and Flinders Medical Centre to compare the 12 month time period prior to the commencement of the intervention to the intervention period.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be analysed on an intention to treat principle (according to site). A secondary analysis will be performed according to those who complete the full protocol (ED protocol and rapid access AF clinic) compared to those who partially complete the protocol (ED protocol only or ED protocol and one visit at the rapid access clinic). Enrolled participant demographic characteristics will be summarised by treatment group. The number of participants who decline study participation or who are ineligible based on inclusion and exclusion criteria will be documented. As this is a cluster-controlled trial, differences in baseline characteristics will be examined by treatment group. In all statistical analyses, a p value of <0.05 will be considered significant.

In order to account for potential baseline differences in rates of admission to hospital between the two sites, 12 months of coding data (presentations to ED coded as AF by principal diagnosis) from each site will be requested for the time period immediately prior to study commencement to determine if rates of admission to hospital for AF are similar across sites. Furthermore, to elucidate the impact of the intervention at the RAH, the 12 months preceding the intervention will be compared to the intervention period to ascertain the impact of the intervention on admission to hospital for AF (before and after comparison).

Participants will be categorised into two groups based on their admission status to hospital from the emergency department for atrial fibrillation or flutter. The primary outcome will be analysed using a multivariable logistic regression and presented using odds ratios with 95% confidence intervals. Secondary outcomes will be analysed as follows: the number of hospitalisations in the intervention and control arms will be analysed using multivariable Poisson regression and will be presented as using incidence rate ratios (IRR) with 95% CI. Questionnaire parameters will be analysed using mixed effects models. Differences in time to first hospitalisation between groups will be analysed using the log rank test, Kaplan-Meier and Cox Proportional Hazard models for AF, other cardiovascular reasons and all cause hospital admissions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2023
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
458
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20142 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 20143 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 34867 0
5000 - Adelaide
Recruitment postcode(s) [2] 34868 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 309335 0
Charities/Societies/Foundations
Name [1] 309335 0
Central Adelaide Local Health Network CEO Clinical Rapid Implementation Project Scheme Grant
Country [1] 309335 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network
Address
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 310301 0
University
Name [1] 310301 0
Centre for Heart Rhythm Disorders, University of Adelaide
Address [1] 310301 0
c/- Department of Cardiology
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country [1] 310301 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309153 0
Central Adelaide Local Health Network
Ethics committee address [1] 309153 0
Ethics committee country [1] 309153 0
Australia
Date submitted for ethics approval [1] 309153 0
02/08/2021
Approval date [1] 309153 0
10/11/2021
Ethics approval number [1] 309153 0

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

Contacts
Principal investigator
Name 113170 0
Prof Prashanthan Sanders
Address 113170 0
Centre for Heart Rhythm Disorders
University of Adelaide
c/- Department of Cardiology
Royal Adelaide Hospital
Port Road
Adelaide
South Australia, 5000
Country 113170 0
Australia
Phone 113170 0
+61 8 7074 1779
Fax 113170 0
+61 8 8362 2273
Email 113170 0
[email protected]
Contact person for public queries
Name 113171 0
Prashanthan Sanders
Address 113171 0
Centre for Heart Rhythm Disorders
University of Adelaide
c/- Department of Cardiology
Royal Adelaide Hospital
Port Road
Adelaide
South Australia, 5000
Country 113171 0
Australia
Phone 113171 0
+61 8 7074 1779
Fax 113171 0
+61 8 8362 2273
Email 113171 0
[email protected]
Contact person for scientific queries
Name 113172 0
Prashanthan Sanders
Address 113172 0
Centre for Heart Rhythm Disorders
University of Adelaide
c/- Department of Cardiology
Royal Adelaide Hospital
Port Road
Adelaide
South Australia, 5000
Country 113172 0
Australia
Phone 113172 0
+61 8 7074 1779
Fax 113172 0
+61 8 8362 2273
Email 113172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified individual participant data of published results may be made available upon request to the Steering Committee of the trial.
When will data be available (start and end dates)?
For a period of 5 years following publication of all study results.
Available to whom?
Data requests can be made to the Steering Committee who will consider all requests.
Available for what types of analyses?
All data requests will be considered by the Steering Committee for any purpose.
How or where can data be obtained?
Applications can be made to the Steering Committee following publication of all results. All data requests can be sent to:
Email: [email protected]


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.