AIHEMAF - P "An Innovative Healthcare Model for AF Patients" (AIHEMAF - P)

October 7, 2023 updated by: Farmacia La Regina s.r.l.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Salerno
      • San Rufo, Salerno, Italy, 84030
        • Farmacia La Regina s.r.l.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients suffering from Non-Valvular Atrial Fibrillation and being treated with new generation oral anticoagulants;

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group Study
Follow up of the patients for 12 months by the community pharmacist in the role of case manager and execution of the activities foreseen by the PAI (individual assistance plan) through telemedicine (ecg, cardiac holter) and self analysis (hemoglobin, hematocrit, creatinine).
Other: Follow up
like group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Model implementation description
Time Frame: 12 months
The primary outcome is mainly descriptive. In fact, the primary objective of the study is to describe the implementation and outcomes of an innovative Smart Clinic model useful for the clinical and pharmacological monitoring of the patient suffering from non-valvular atrial fibrillation treated with new generation oral anticoagulants, in which a community pharmacist, adequately trained, takes on the role of case manager and the patient has the possibility to perform the checks provided in telemedicine and in self-analysis, in the service pharmacy regime, the results of which will be shared in real time with the treating physician and reference specialist of the same. This model is new as there is no coagulation clinic in Italy as in other countries of the world.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants With Adherence to the PDTA
Time Frame: 12 months
Measure of the variation of the percentage of adherence to PDTA (patients who performed the scheduled checks at 1-3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of "pharmacy of service".
12 months
Prescriptive appropriateness
Time Frame: 12 months
detection of the number of cases in which the therapy must be changed (molecule or dosage) or suspended because it is not appropriate
12 months
Adherence to therapy
Time Frame: 12 months
detection of cases in which the therapy was not followed correctly
12 months
Pharmacological problems
Time Frame: 12 months
detection of cases in which drug therapy needs to be revised due to drug-drug interactions
12 months
Bleeding and / or thrombo-embolic complications;
Time Frame: 12 months
detection of cases of bleeding and / or thrombo-embolic complications
12 months
Acceptance of reports
Time Frame: 12 months
detection of cases in which the general practitioner or specialist doctor accepts the reports of the pharmacist
12 months
Economic Impact
Time Frame: 12 months
Evaluation of the economic impact secondary to the establishment of the figure of the community pharmacist as Case Manager and to the use of the "pharmacy of service" (Comparison costs/benefits in euro between traditional assistence model and this innovative assistance model) (comparison between the costs currently incurred by the Italian health care system for the assistance to AF patients on doac therapy and the related benefits and costs deriving from the adoption of a care model such as the one object of research and the relative benefits)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Farmacia La Regina s.r.l.

Collaborators

Istituto Superiore di Sanità
Università degli Studi di Brescia
Nova Biomedical Italia s.r.l.
HTN - Health Telematic Network S.r.l.
Centro Studi Federfarma

Investigators

  • Principal Investigator: Raffaele La Regina, DR, Farmacia La Regina srl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

September 19, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be shared only in aggregate and anonymous form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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