Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05086991
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2021-09-19
Brief Title:
AIHEMAF - P An Innovative Healthcare Model for AF Patients
Sponsor:
Farmacia La Regina srl
Organization:
Farmacia La Regina srl
Study Overview
Official Title:
AIHEMAF - P An Innovative Healthcare Model for AF Patients No-profit Observational Study on the Role of the Community Pharmacist and The Pharmacy of Services in the Case Management of Patients Suffering From Atrial Fibrillation and Being Treated With New Generation Oral Anticoagulants
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIHEMAF - P
Brief Summary:
Non-profit observational study on the role of the community pharmacist and the pharmacy of services in the case management of patients suffering from atrial fibrillation and being treated with new generation oral anticoagulants
Detailed Description:
Atrial fibrillation is one of the most common cardiac arrhythmias from which in Italy more than a million people are affected and estimates speak of an increase of up to 70 in the coming years Due to its ability to increase the thrombo-embolic risk the affected people are subjected to anticoagulant and antiarrhythmic pharmacological interventions in order to protect the patient from highly disabling events such as cerebral stroke or other arterial embolisms
However these pharmacological therapies require a dynamic approach over time as the choice of active ingredients and the relative dosages depend on the patients overall health status and for this reason it is important that he adheres to the monitoring plan prepared by a specialist in cardiology so that therapeutic appropriateness is always guaranteedù
In daily clinical practice the follow-up activities defined by the guidelines of the European Society of Cardiology ESC consist in the evaluation of
General health status
Bleeding events and related risk
Therapeutic adherence
Kidney function
Drug interactions
Control of heart rhythm and related symptoms
Pathology progression
In the recent past these activities were carried out solely and exclusively by the Specialist Doctor as the only person authorized to prescribe the new oral anticoagulant drugs Only recently with the introduction of the AIFA 97 note the General Practitioner was given the opportunity to prescribe these drugs to the patient suffering from Non-Valvular Atrial Fibrillation and to carry out the necessary monitoring Consequently the visit to the Specialist is reduced to once a year or whenever the General Practitioner deems it appropriate
However the recent epidemiological emergency has highlighted the need to redesign the follow-up pathways of these patients in order to reduce interpersonal contacts today and to simplify those pathways tomorrow In fact nowadays patients suffering from atrial fibrillation and on anticoagulant therapy must carry out a series of interminable steps to comply with all the activities provided for in their follow-up plan This as the National Health System is organized today therefore translates into a lose-lose scenario due to the lack of reconciliation between the diagnostic and therapeutic activities to be carried out and the rhythms of life
On the basis of this it is necessary to design follow-up models which thanks to the territorial integration of all the care settings and the related health professionals available allow the patient to be able to enjoy 0 km assistance models which allow him to carry out the activities provided for in the treatment plans in the simplest and most immediate way possible in order to be able to guarantee in a timely manner the most suitable treatments for your state of health foreseeing and preventing complications and responding effectively and efficiently to the needs emerging
Among the health professionals available to date that of the Territorial Pharmacist is little considered which represents due to the position in which it is found within the National Health Service a potential that has not yet been fully exploited In fact he could take on the role of case manager professional who manages one or more cases entrusted to him according to a predetermined path such as the PDTA in a defined space-time context of the patient suffering from atrial fibrillation and in therapy with oral anticoagulants of new generation thanks to the capillarity on the territory the hourly availability higher than any other territorial health facility the health skills in its possession and what it can offer in terms of services within the so-called service pharmacy In this scenario the pharmacist would not replace any of the other actors already present in the multidisciplinary care team but would integrate into it and moreover being already affiliated with the National Health Service the conferral of this role would not cause a excessive cost increases such as that which would result from hiring new staff to achieve the same goals The involvement of local pharmacists in the case management of these patients could represent the sustainable key for de-hospitalization of chronic patients which has been talked about for some time without being able to find concrete and at the same time not particularly costly solutions and the gateway to the Service National Healthcare that allows them to monitor their state of health be supported in their activities and remain connected with all the other actors in the care process
However these pharmacological therapies require a dynamic approach over time as the choice of active ingredients and the relative dosages depend on the patients overall health status and for this reason it is important that he adheres to the monitoring plan prepared by a specialist in cardiology so that therapeutic appropriateness is always guaranteedù
In daily clinical practice the follow-up activities defined by the guidelines of the European Society of Cardiology ESC consist in the evaluation of
General health status
Bleeding events and related risk
Therapeutic adherence
Kidney function
Drug interactions
Control of heart rhythm and related symptoms
Pathology progression
In the recent past these activities were carried out solely and exclusively by the Specialist Doctor as the only person authorized to prescribe the new oral anticoagulant drugs Only recently with the introduction of the AIFA 97 note the General Practitioner was given the opportunity to prescribe these drugs to the patient suffering from Non-Valvular Atrial Fibrillation and to carry out the necessary monitoring Consequently the visit to the Specialist is reduced to once a year or whenever the General Practitioner deems it appropriate
However the recent epidemiological emergency has highlighted the need to redesign the follow-up pathways of these patients in order to reduce interpersonal contacts today and to simplify those pathways tomorrow In fact nowadays patients suffering from atrial fibrillation and on anticoagulant therapy must carry out a series of interminable steps to comply with all the activities provided for in their follow-up plan This as the National Health System is organized today therefore translates into a lose-lose scenario due to the lack of reconciliation between the diagnostic and therapeutic activities to be carried out and the rhythms of life
On the basis of this it is necessary to design follow-up models which thanks to the territorial integration of all the care settings and the related health professionals available allow the patient to be able to enjoy 0 km assistance models which allow him to carry out the activities provided for in the treatment plans in the simplest and most immediate way possible in order to be able to guarantee in a timely manner the most suitable treatments for your state of health foreseeing and preventing complications and responding effectively and efficiently to the needs emerging
Among the health professionals available to date that of the Territorial Pharmacist is little considered which represents due to the position in which it is found within the National Health Service a potential that has not yet been fully exploited In fact he could take on the role of case manager professional who manages one or more cases entrusted to him according to a predetermined path such as the PDTA in a defined space-time context of the patient suffering from atrial fibrillation and in therapy with oral anticoagulants of new generation thanks to the capillarity on the territory the hourly availability higher than any other territorial health facility the health skills in its possession and what it can offer in terms of services within the so-called service pharmacy In this scenario the pharmacist would not replace any of the other actors already present in the multidisciplinary care team but would integrate into it and moreover being already affiliated with the National Health Service the conferral of this role would not cause a excessive cost increases such as that which would result from hiring new staff to achieve the same goals The involvement of local pharmacists in the case management of these patients could represent the sustainable key for de-hospitalization of chronic patients which has been talked about for some time without being able to find concrete and at the same time not particularly costly solutions and the gateway to the Service National Healthcare that allows them to monitor their state of health be supported in their activities and remain connected with all the other actors in the care process
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