Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03115190
Status:
TERMINATED
Last Update Posted:
2021-01-07
First Post:
2017-04-11
Brief Title:
Improving the Referral of Patients With Chest Pain
Sponsor:
VieCuri Medical Centre
Organization:
VieCuri Medical Centre
Study Overview
Official Title:
A Prospective Cohort Study to Improve the Accuracy of Referrals of Patients With Chest Pain to the Emergency Department to Decrease the Delay in Acute Coronary Syndrome Patients and Rule Out Non-cardiac Chest Pain Patients URGENT
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Philips Minicare has been taken off the market due to financial company issues that have nothing to do with the safety of the Minicare or the URGENT trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Urgent
Brief Summary:
Rationale This study aims to aid the general practitioner GP in the diagnostic dilemma of chest pain patients Patients with acute coronary syndrome ACS should be referred to the hospital promptly though referring all patients with chest pain is not feasible as up to 80 of the patients with chest pain in the primary care do not have ACS
Objective The primary objective is to refer patients who contact the out-of-hours GP cooperation GPC with suspicion of ACS more accurately with a hypothesized reduction of 10 in unnecessary referrals
Study design This study is a prospective observational prevalence-based cohort study within the standard care of ACS patients
Study population All patients with chest pain or other complaints suspect of ACS will be included in which the GP at the GPC is in need of further diagnostics to come to a decision of referral The follow-up will be a registry of all patients with suspected ACS referred to the emergency department ED Patients with typical complaints of ACS and thus a high suspicion will be excluded and referred promptly
Intervention Triage nurses working at the GPC will receive specific ACS training Patients who arrive at the GPC with non-typical chest pain will be screened for enrolment within the study The GP evaluates patients using the Heart score this includes electrocardiogram recording and point of care POC troponin testing With the Heart score the GP can make an informed decision to refer the patient to the ED
To evaluate the intervention a registry of all patients referred to the ED with suspected ACS will be compared to a baseline registry performed from the 1st of September 2015 until the 1st of March 2016 Patients not referred to the ED will have a standard high-sensitivity troponin and a POC troponin as follow-up at least four hours up to 24 hours after first measurement
The burden and risks associated with participation benefit and group relatedness Patients enrolled within this study will receive a finger stick blood test and electrocardiogram recording at the GPC and a finger stick blood test and a venous blood test at least four hours after first troponin measurement We may follow-up by telephone if we can not obtain the required information from medical records We expect no adverse events and there are no expected risks associated with this protocol We expect patients with ACS to be referred more accurately and more promptly to the ED and thus lowering risks
Objective The primary objective is to refer patients who contact the out-of-hours GP cooperation GPC with suspicion of ACS more accurately with a hypothesized reduction of 10 in unnecessary referrals
Study design This study is a prospective observational prevalence-based cohort study within the standard care of ACS patients
Study population All patients with chest pain or other complaints suspect of ACS will be included in which the GP at the GPC is in need of further diagnostics to come to a decision of referral The follow-up will be a registry of all patients with suspected ACS referred to the emergency department ED Patients with typical complaints of ACS and thus a high suspicion will be excluded and referred promptly
Intervention Triage nurses working at the GPC will receive specific ACS training Patients who arrive at the GPC with non-typical chest pain will be screened for enrolment within the study The GP evaluates patients using the Heart score this includes electrocardiogram recording and point of care POC troponin testing With the Heart score the GP can make an informed decision to refer the patient to the ED
To evaluate the intervention a registry of all patients referred to the ED with suspected ACS will be compared to a baseline registry performed from the 1st of September 2015 until the 1st of March 2016 Patients not referred to the ED will have a standard high-sensitivity troponin and a POC troponin as follow-up at least four hours up to 24 hours after first measurement
The burden and risks associated with participation benefit and group relatedness Patients enrolled within this study will receive a finger stick blood test and electrocardiogram recording at the GPC and a finger stick blood test and a venous blood test at least four hours after first troponin measurement We may follow-up by telephone if we can not obtain the required information from medical records We expect no adverse events and there are no expected risks associated with this protocol We expect patients with ACS to be referred more accurately and more promptly to the ED and thus lowering risks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None