Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598930
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Evaluation of the Effectiveness of Intensive Medical Follow-up with an Advanced Practice Nurse Compared with Medical Follow-up Alone in Non-severe Pulmonary Embolism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy of Intensive Medical Follow-up with an Advanced Practice Nurse Compared with Medical Follow-up Alone in Non-severe Pulmonary Embolism - Randomised Open Study At Dijon University Hospital and Langres University Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InCaPE
Brief Summary:
In France venous thromboembolism VTE which includes pulmonary embolism PE and deep-vein thrombosis DVT is the 3rd leading cause of cardiovascular disease leading to major public health problems Despite current monitoring and treatment the recurrence rate and the rate of haemorrhagic complications remain high at 185 and 12 respectively in the year following the thrombotic event
Patients with PE diagnosed in the emergency department are very often admitted to hospital
However according to international recommendations on the treatment of PE outpatient management with early discharge could be envisaged but is rarely carried out in practice particularly for non-severe PE spESI 0
Current post-pulmonary embolism follow-up involves an early medical consultation with a specialist after discharge from hospital with follow-up at 1 3 and 6 months The aim is to evaluate anticoagulant treatment high-risk medication investigate the causes of PE monitor the patient and decide whether or not to continue anticoagulant treatment 6 months after diagnosis
Patients diagnosed with non-severe PE can only be monitored as soon as they are discharged from hospital thanks to an organised and specific care pathway involving healthcare professionals working in towns and cities as well as in hospitals
In 2018 the French authorities created a new healthcare profession the advanced practice nurse APN They are said to be one of the 39answers39 to making care pathways including PE even more relevant by improving the quality of patient care and strengthening the town-hospital link
Thanks to their training and expertise IPAs can carry out the following activities
Observation collection and interpretation of data in the context of patient monitoring in hisher area of expertise
Prescribing renewing prescriptions and carrying out technical procedures as part of patient follow-up in their area of expertise
Designing implementing and evaluating preventive and therapeutic education measures
Thus by intervening at specific times throughout the course of a patient39s diagnosis of a non-severe PE the involvement of the IPA in the patient39s follow-up in addition to current recommendations would make it possible to reduce the risk of haemorrhagic complications associated with the use of anticoagulants
Patients with PE diagnosed in the emergency department are very often admitted to hospital
However according to international recommendations on the treatment of PE outpatient management with early discharge could be envisaged but is rarely carried out in practice particularly for non-severe PE spESI 0
Current post-pulmonary embolism follow-up involves an early medical consultation with a specialist after discharge from hospital with follow-up at 1 3 and 6 months The aim is to evaluate anticoagulant treatment high-risk medication investigate the causes of PE monitor the patient and decide whether or not to continue anticoagulant treatment 6 months after diagnosis
Patients diagnosed with non-severe PE can only be monitored as soon as they are discharged from hospital thanks to an organised and specific care pathway involving healthcare professionals working in towns and cities as well as in hospitals
In 2018 the French authorities created a new healthcare profession the advanced practice nurse APN They are said to be one of the 39answers39 to making care pathways including PE even more relevant by improving the quality of patient care and strengthening the town-hospital link
Thanks to their training and expertise IPAs can carry out the following activities
Observation collection and interpretation of data in the context of patient monitoring in hisher area of expertise
Prescribing renewing prescriptions and carrying out technical procedures as part of patient follow-up in their area of expertise
Designing implementing and evaluating preventive and therapeutic education measures
Thus by intervening at specific times throughout the course of a patient39s diagnosis of a non-severe PE the involvement of the IPA in the patient39s follow-up in addition to current recommendations would make it possible to reduce the risk of haemorrhagic complications associated with the use of anticoagulants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None