Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000904471
Ethics application status
Approved
Date submitted
6/07/2016
Date registered
8/07/2016
Date last updated
1/05/2019
Date data sharing statement initially provided
1/05/2019
Date results information initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using innovative technology to identify postoperative atrial fibrillation recurrence in non-cardiac surgical patients after hospital discharge
Scientific title
Identifying postoperative atrial fibrillation recurrence in non-cardiac surgical patients after hospital discharge using an iPhone electrocardiogram
Secondary ID [1] 289530 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 299239 0
Condition category
Condition code
Cardiovascular 299249 299249 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
STUDY POPULATION:
All patients with an in-hospital episode of new-onset atrial fibrillation (AF), secondary to admission for non-cardiac surgery or acute medical illness (i.e. admitted to hospital in sinus rhythm; no AF history); AND reversion or successful cardioversion to sinus rhythm prior to discharge; AND age >or= 40 years. Patients must be able to provide informed consent. Patients will be excluded if they are non-English speaking; or have insufficient cognitive capacity for the consent and interview process; or are unable to be contacted in the post-discharge period

INTERVENTION:
All consenting patients will receive approximately 10 minutes of AF education from the research cardiac nurse, during their inpatient stay. The education will be one-on-one, and will specifically cover what AF is, the associated health risks (particularly stroke), AF symptoms, and AF treatment. Patients will be offered the choice of either a 2-page education handout from the Australian Atrial fibrillation Association (i.e. AF Fact sheet: http://www.atrialfibrillation-au.org/files/file/Publications/02082013%20AFA%20Australia%20Atrial%20Fibrillation%20-%20(P).pdf); or a more detailed 15-page handout from the Australian National Heart Foundation (https://heartfoundation.org.au/images/uploads/publications/CON-175_Atrial_Fibrillation_WEB.PDF).

Participants will also be provided with a handheld smartphone ECG device called the Kardia (AliveCor) Heart monitor which is an approved medical device (ARTG Identifier 208100). The Kardia Heart monitor is a special cover that attaches to a smartphone, which enables a single lead ECG reading to be taken using an application on the smartphone. Participants will be taught how to record their own ECG recording.

Following hospital discharge, participants will commence recording an ECG ~5 times/day, continuing for four weeks. Recordings will be spread out through the day at times suitable to the participant (e.g. Immediately before breakfast, lunch, dinner and sleep). Participants experiencing symptoms possibly due to AF (including palpitations, dizziness and syncope) will record these in a diary and perform additional ECG recordings.

Each ECG will be analysed by the validated ‘on-device algorithm’ to give them a rhythm diagnosis. If ‘possible AF’ is diagnosed, the participant will take additional ECG recordings, and contact their treating doctor for review as soon as practicable. Each ECG recording automatically transmits to a secure server. All ECG data on the server are coded for each participant and therefore are not identifiable by a third party. The research assistant will review each ECG and the algorithm diagnosis, and will contact participants to ensure they have appropriately followed up any abnormal ECG’s with their treating general practitioner.

FOLLOW UP:
A follow-up assessment will be performed 4 weeks post hospital discharge. On completion, a letter summarising the participant’s specific outcomes will be sent to their treating doctors. The participant will also be invited to participate in semi-structured interviews to explore their experience using the handheld ECG and factors related to future sustainability. All participants will receive a final follow-up phone call at 3 months.
Intervention code [1] 295122 0
Early detection / Screening
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298732 0
Feasibility of patient self-monitoring for secondary atrial fibrillation (AF) recurrence, following admission for non-cardiac surgery or acute medical illness, using a handheld single lead ECG (assessed with compliance data; and qualitative data including acceptability, competing demands, barriers, and enablers - measured with semi-structured interviews with participants and a selection of health professionals)
Timepoint [1] 298732 0
Completion of study
Secondary outcome [1] 325084 0
Incidence of secondary AF (post non-cardiac surgery or acute medical illness) that reverts to sinus rhythm prior to discharge (expressed as number of identified cases divided by total number of patients screened (post non-cardiac surgery or acute medical illness), with accompanying 95% confidence intervals)
Timepoint [1] 325084 0
Completion of study
Secondary outcome [2] 325086 0
The proportion of patients identified with recurrent secondary AF following discharge (identified using the self-administered single-lead smartphone ECG [Kardia - AliveCor Heart monitor]) (assessed at 4 weeks post discharge) (expressed as true positives divided by total number screened with accompanying 95% confidence intervals)
Timepoint [2] 325086 0
Completion of the study
Secondary outcome [3] 325281 0
Thromboembolic and bleeding risk profile
(assessed during the initial assessment, using the CHAD2S2-VASc and HAS-BLED scores; and expressed as rates)
Timepoint [3] 325281 0
Information will be collected at initial assessment for each participant
Secondary outcome will be evaluated at the completion of the study
Secondary outcome [4] 325288 0
Acceptability and patient willingness to participate in the program
(measured using recruitment data and qualitative process evaluation using semi-structured interviews performed 4 weeks post hospital discharge)
Timepoint [4] 325288 0
Completion of study
Secondary outcome [5] 325289 0
Compliance of participants to the intervention (Assessed at 4 weeks post discharge) (measured by number of actual iECG recordings compared to requested protocol; and if participants actioned a review with their treating doctors if "suspected AF" was diagnosed by the on-device automated algorithm)
Timepoint [5] 325289 0
Completion of study
Secondary outcome [6] 325290 0
Percentage of participants that were appropriately prescribed oral anticoagulation following identification of a recurrence of postoperative AF (assessed by phone call to participant at 3 months post discharge; oral anticoagulation eligibility assessed according to CHAD2S2-VASc score =1 in males, OR score greater than or equal to 2 in all)
(expressed as rates)
Timepoint [6] 325290 0
Completion of study

Eligibility
Key inclusion criteria
All patients with an in-hospital episode of new-onset secondary AF following admission for non-cardiac surgery or an acute medical illness (i.e. admitted to hospital in sinus rhythm; no AF history);
AND reversion or successful cardioversion to sinus rhythm prior to discharge;
AND age > or =40 years.
Patients must be able to provide informed consent.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are non-English speaking; or have insufficient cognitive capacity for the consent and interview process; or are unable to be contacted in the post-discharge period.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified from the surgical and medical wards by the research assistant. The research assistant will assess eligibility against the inclusion/exclusion criteria, and approach all eligible participants during their in-patient stay. The study and the commitment involved will be clearly described in lay terms. Potential participants will be afforded every opportunity to ask questions about the study without prejudice, and to choose whether or not to participate. Participation in the study is entirely voluntary and choosing not to participate will not in any way affect any future treatment. There are no rewards or incentives for participation in the study.

The participant will be enrolled into the study after the informed consent process has been completed.

As this is a pre-post study and all participants will receive the intervention, there will be no randomisation and the study will not be blinded.
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
Single group
Other design features
Cross sectional design
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Primary analyses will be conducted using SPSS for Windows (Version 22.0). New episodes of AF will be expressed as true positives divided by total number screened with accompanying 95% confidence intervals. Chi-squared tests will be used to compare new cases by gender and to identify associations between AF incidence and age-group or AF risk factors. AF knowledge level will be compared pre- and post-intervention using paired t-tests. Continuous variables will be reported as means +/- standard deviations (SD), and categorical variables as numbers and percentages. Within subject differences between baseline and follow-up will be analysed using Wilcoxon signed ranks tests for non-parametric variables (two tailed p< 0.05 considered significant).

As the primary outcome is feasibility and acceptability, a power calculation was not performed. A sample size of 50 participants (with POAF) was chosen to maximise the probability of reaching data saturation during thematic analysis of the interviews and during review of process measures such as reasons for declining participation. Analysis will be limited to complete cases to avoid artificially increasing precision around the estimates by imputing values or carrying baseline values forward. As the study is a pilot study no interim analyses are anticipated. Interview data will be transcribed verbatim and analysed using general interpretive methods. Transcripts will be reviewed independently for general themes by two researchers and consensus reached.

QUALITATIVE: A detailed process evaluation will be undertaken to better appreciate factors that might influence sustainability beyond the trial setting. After each participant completes the program, a process evaluation will be performed related to participant’s experiences with the iECG. Semi-structured interviews will be conducted addressing the ease of use of the iECG, and the benefits and challenges of the program. The process evaluation interview will be audio-taped to ensure accurate transcription of the information, with the written consent of the participant. The audio recording will be transcribed verbatim in a non-identifiable form and the recording deleted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/07/2016
Actual
1/05/2017
Date of last participant enrolment
Anticipated
28/02/2018
Actual
30/08/2018
Date of last data collection
Anticipated
30/03/2018
Actual
30/11/2018
Sample size
Target
50
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 6016 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 6071 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 9625 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 13447 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [2] 18382 0
2250 - Gosford
Recruitment postcode(s) [3] 13549 0
6847 - Perth

Funding & Sponsors
Funding source category [1] 293906 0
Charities/Societies/Foundations
Name [1] 293906 0
National Heart Foundation of Australia
Country [1] 293906 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney,
City Road,
Camperdown, NSW, 2006
Australia
Country
Australia
Secondary sponsor category [1] 292731 0
None
Name [1] 292731 0
Address [1] 292731 0
Country [1] 292731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295323 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 295323 0
Sydney Local Health District Human Research Ethics Committee-CRGH
Hospital Road
Concord Repatriation General Hospital (CRGH)
Concord NSW 2139
Ethics committee country [1] 295323 0
Australia
Date submitted for ethics approval [1] 295323 0
28/02/2016
Approval date [1] 295323 0
27/04/2016
Ethics approval number [1] 295323 0
HREC/16/CRGH/34 (CH62/6/2016-028)
Ethics committee name [2] 295425 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [2] 295425 0
Level 3, Perkins South Building
Fiona Stanley Hospital Campus
11 Robin Warren Drive
MURDOCH WA 6150
Ethics committee country [2] 295425 0
Australia
Date submitted for ethics approval [2] 295425 0
02/05/2016
Approval date [2] 295425 0
29/08/2016
Ethics approval number [2] 295425 0
2016-099

Summary
Brief summary
Atrial fibrillation (AF) is the most common abnormal heart rhythm occurring after surgery and acute medical admissions. Postoperative AF patients, discharged home in normal heart rhythm, have 5 times the stroke risk of those without postoperative AF. Postoperative AF after general surgery has been little studied. After cardiac surgery, patients frequently attend cardiac rehabilitation, and are routinely followed by cardiac professionals. The same support is seldom available after non-cardiac surgery,

New AF, secondary to acute medical illness, is associated with higher long and short term mortality & stroke rates, & increased length of hospital stay. New AF occurs in 7.2% of medical ICU patients; 10% with sepsis; 44% with septic shock; & 10% with acute respiratory distress syndrome. Patients with infections have increased risk of developing new-AF (odds ratio [OR] 1.54), specifically: pneumonia OR 2.6, urinary tract infection OR 1.4, and intra-abdominal infection OR 1.6.

We predict that if AF recurrence is identified early after discharge, strokes can be prevented by effective treatment. Currently, monitoring for recurrence falls mostly on the patient recognising AF symptoms. Unfortunately, AF recurrence is largely asymptomatic or has non-specific symptoms confused with normal recovery and therefore unlikely to be identified by the patient.

We hypothesise patients can self-identify early recurrent secondary AF post-discharge, by taking multiple daily recordings for a month using a simple handheld smartphone ECG which provides an accurate, immediate AF diagnosis. Before commencing a larger expensive trial it is necessary to test the feasibility of the intervention, and provide an estimate of the rate of symptomatic and asymptomatic secondary AF. Results from this feasibility study will inform and refine the design of a larger intervention study.

Primary aims are to provide data regarding feasibility of patient self-monitoring for AF recurrence post discharge using an iECG. The secondary end-points relate to the incidence of secondary AF following non-cardiac surgery or acute medical illness, and the incidence of AF recurrence following discharge.

This cross sectional feasibility study will recruit 50 patients with new-onset post-operative AF following non-cardiac surgery, who have returned to normal sinus rhythm prior to discharge. Participants will be provided with a handheld smartphone; and will record an ECG ~5 x/day for 4 weeks.

Participants experiencing possible AF symptoms will keep a diary of these and perform additional ECG recordings. Each ECG is analysed by the ‘on-device algorithm’. If ‘possible AF’ is diagnosed, the participant will take additional ECG recordings, and contact their treating doctor for review as soon as practicable. The research assistant will review each ECG and the algorithm diagnosis, and will contact participants to ensure they have appropriately followed up any abnormal ECG’s.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66882 0
Dr Nicole Lowres
Address 66882 0
Level 2,
Charles Perkins Centre,
Building D17, University of Sydney,
Missenden Rd, Camperdown, 2006
NSW, Australia
Country 66882 0
Australia
Phone 66882 0
+61 2 8627 0291
Fax 66882 0
Email 66882 0
nicole.lowres@sydney.edu.au
Contact person for public queries
Name 66883 0
Ben Freedman
Address 66883 0
Heart Research Institute,
Level 3,
Charles Perkins Centre,
Building D17, University of Sydney,
Missenden Rd, Camperdown, 2006
NSW, Australia
Country 66883 0
Australia
Phone 66883 0
+61 2 9114 2199
Fax 66883 0
Email 66883 0
ben.freedman@sydney.edu.au
Contact person for scientific queries
Name 66884 0
Ben Freedman
Address 66884 0
Heart Research Institute,
Level 3,
Charles Perkins Centre,
Building D17, University of Sydney,
Missenden Rd
Camperdown, NSW, 2006
Country 66884 0
Australia
Phone 66884 0
+61 2 9114 2199
Fax 66884 0
Email 66884 0
ben.freedman@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.