Multi-centre randomised controlled trial of a smart phone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope - the IPED (Investigation of Palpitations in the ED) study: study protocol for a randomised controlled trial

Reed, Matthew J.; Grubb, Neil R.; Lang, Christopher C.; O’Brien, Rachel; Simpson, Kirsty; Padarenga, Mia; Grant, Alison; Tuck, Sharon

doi:10.1186/s13063-018-3098-1

Cited by 17Cardiovascular Syncope and Autonomic DisordersCardiac electrophysiology and arrhythmiasECG Monitoring and Analysis

Multi-centre randomised controlled trial of a smart phone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope - the IPED (Investigation of Palpitations in the ED) study: study protocol for a randomised controlled trial

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Reed, Matthew J., Grubb, Neil R., Lang, Christopher C., O’Brien, Rachel, Simpson, Kirsty, Padarenga, Mia, Grant, Alison, Tuck, Sharon·2018·Trials

DOI 10.1186/s13063-018-3098-1PMC PMC6311046

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Abstract

BACKGROUND: Palpitations and pre-syncope are together responsible for 300,000 annual Emergency Department (ED) attendances in the United Kingdom (UK). Diagnosis of the underlying rhythm is difficult as many patients are fully recovered on ED arrival; and examination and presenting electrocardiogram (ECG) are commonly normal. The only way to establish the underlying heart rhythm is to capture an ECG during symptoms. Recent technology advances have led to several novel ECG monitoring devices appearing on the market. This trial aims to compare the symptomatic rhythm detection rate at 90 days of one such smart phone-based event recorder (AliveCor Heart Monitor and AliveECG) with standard care for participants presenting to the ED with palpitations and pre-syncope and no obvious cause in the ED. METHODS/DESIGN: This is a multi-centre hospital ED / Acute Medical Unit (AMU) open label, randomised controlled trial. Participants will be recruited in 10 tertiary and district general hospitals in the UK. Participants aged ≥ 16 years presenting with an episode of palpitations or pre-syncope with no obvious cause and whose underlying ECG rhythm during these episodes remains undiagnosed after clinical assessment will be included. Participants will be randomised to either: (1) the intervention arm, standard care plus the use of a smart phone-based event recorder; or (2) the control arm, standard care. Primary endpoint will be symptomatic rhythm detection rate at 90 days. A number of secondary clinical, process and cost-effectiveness endpoints will be collected and analysed. Analysis will be on an intention-to-treat basis. DISCUSSION: The Investigation of Palpitations in the ED (IPED) study aims to recruit 242 participants across 10 hospital sites. It will be the first study to investigate the ability of a smart phone-based event recorder to detect symptomatic cardiac rhythms compared to standard care for ED patients with palpitations and pre-syncope with no obvious cause in the ED. This smart phone event recorder will allow ED patients who have presented with palpitations or pre-syncope to record their ECG tracing if they have a further episode and may increase the rate of underlying rhythm diagnosis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02783898 . Registered on 26 May 2016.

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The trial was registered at ClinicalTrials.gov (NCT02783898) and the protocol was published.
“This trial was registered at ClinicalTrials.gov (trial registration number NCT02783898), and the protocol published in Trials [26].”
From Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study (2019) · cites this paper as [26]

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Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study
Reed, M. J., Grubb, N. R., Lang, C. C., O'Brien, R., Simpson, K., Padarenga, M., Grant, A., Tuck, S., Keating, L., Coffey, F., et al. (2019) · EClinicalMedicine · doi:10.1016/j.eclinm.2019.02.005 · Cited by 57 · see citing works
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018 Clinician prediction of cardiac arrhythmia in patients presenting to the ED with palpitation or pre-syncope
Reed, M. J., Grubb, N. R., Lang, C., O’Brien, R., Simpson, K., Padarenga, M., Grant, A., Tuck, S., Keating, L., Coffey, F., et al. (2019) · Emergency Medicine Journal · doi:10.1136/emermed-2019-rcem.18 · Cited by 1 · see citing works
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023 For how long should we monitor ED palpitation patients in the outpatient setting?
Reed, M. J., Grubb, N. R., Lang, C., O’Brien, R., Simpson, K., Padarenga, M., Grant, A., Tuck, S., Keating, L., Coffey, F., et al. (2019) · Emergency Medicine Journal · doi:10.1136/emermed-2019-rcem.23 · Cited by 1 · see citing works
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Authors: Reed, M. J., Grubb, N. R., Lang, C. C., O’Brien, R., Simpson, K., Padarenga, M., Grant, A., & Tuck, S.
Affiliations: NHS Lothian (GB)
Edinburgh Royal Infirmary (GB)
Western General Hospital (GB)
Corresponding author: Reed, Matthew J.
ORCID: Reed, Matthew J.
O’Brien, Rachel
Grant, Alison
Tuck, Sharon
Venue: Trials
Publisher: Springer Science and Business Media LLC
Published: 2018-12
Volume: 19
Issue: 1
Pages: 711-711
ISSN: 1745-6215 (ISSN-L)
DOI: 10.1186/s13063-018-3098-1
PMC: PMC6311046
OpenAlex: W2907105961
Cited by: 17
References: 21
Citations by year: 2024: 1 · 2022: 4 · 2021: 5 · 2020: 4 · 2019: 3
FWCI: 3.12
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (tdm)
Locations: Trials (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, other-oa)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
Funders: Chest Heart and Stroke Scotland (R15/A164)
British Heart Foundation (PG/17/63/33198)
Topics: Health Sciences › Medicine › Surgery › Cardiovascular Syncope and Autonomic Disorders
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › ECG Monitoring and Analysis
Keywords: palpitations, presyncope, emergency department, arrhythmia diagnosis, wearable ECG monitoring, cost-effectiveness, acute medical unit, unexplained syncope, patient-reported outcomes, patient satisfaction
MeSH terms: Smartphone, Arrhythmias, Cardiac, Emergency Service, Hospital, United Kingdom, Heart Rate, Humans, Predictive Value of Tests, Prognosis, Syncope, Telemetry, Time Factors, Multicenter Studies as Topic, Electrocardiography, Ambulatory, Randomized Controlled Trials as Topic, Mobile Applications

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