Clinical trial NCT05086991: AIHEMAF - P "An Innovative Healthcare Model for AF Patients"
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: adherence
therapy
follow up
community pharmacy
pharmacist
case manager
telemedicine
pharmacy of service
pharmacological therapy check
ecg
general physician
Cardiology Specialist
Doac
Noac
Lead sponsor: Farmacia La Regina s.r.l.
Sponsor class: OTHER
Collaborators: name: Istituto Superiore di Sanità
name: Università degli Studi di Brescia
name: Nova Biomedical Italia s.r.l.
name: Health Telematic Network
name: Centro Studi Federfarma
First posted: 2021-10-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from Non-Valvular Atrial Fibrillation and being treated with new generation oral anticoagulants;

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 patient's 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 guaranteed.ù

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.

Eligibility criteria: Inclusion Criteria:

* age\> 18 years,
* patients suffering from Non-Valvular Atrial Fibrillation and being treated with new generation oral anticoagulants;
* able to express consent to the study;
* regularly related to the trial site (Farmacia La Regina S.r.l.)
* AntiCovid19 vaccination performed.

Exclusion Criteria:

* Nobody

Primary outcomes:
measure: Model implementation description
timeFrame: 12 months
Secondary outcomes:
measure: Percent of Participants With Adherence to the PDTA
timeFrame: 12 months
measure: Prescriptive appropriateness
timeFrame: 12 months
measure: Adherence to therapy
timeFrame: 12 months
measure: Pharmacological problems
timeFrame: 12 months
measure: Bleeding and / or thrombo-embolic complications;
timeFrame: 12 months
measure: Acceptance of reports
timeFrame: 12 months
measure: Economic Impact
timeFrame: 12 months
Other outcomes:
Locations:
city: San Rufo
country: Italy
facility: Farmacia La Regina s.r.l.
state: Salerno
Study officials:
affiliation: Farmacia La Regina srl
name: Raffaele La Regina, DR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corrigendum to: 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2021 Feb 1;42(5):546-547. doi: 10.1093/eurheartj/ehaa945. No abstract available.
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