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

NCT05086991 | Completed

• 1 other identifier: 2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Model implementation description

  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 Outcomes (7)

• Percent of Participants With Adherence to the PDTA

  12 months

• Prescriptive appropriateness

  12 months

• Adherence to therapy

  12 months

• Pharmacological problems

  12 months

• Bleeding and / or thrombo-embolic complications;

  12 months

Study Arms (1)

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

Interventions

Follow up OTHER

like group descriptions

Group Study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Nobody

Sponsors & Collaborators

• Farmacia La Regina s.r.l.: lead
• Istituto Superiore di Sanità: collaborator
• Università degli Studi di Brescia: collaborator
• Nova Biomedical Italia s.r.l.: collaborator
• Health Telematic Network: collaborator
• Centro Studi Federfarma: collaborator

Study Sites (1)

Farmacia La Regina s.r.l.

San Rufo, Salerno, 84030, Italy

Location

Related Publications (13)

• 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.

  PMID: 33242070 BACKGROUND

• Steffel J, Verhamme P, Potpara TS, Albaladejo P, Antz M, Desteghe L, Haeusler KG, Oldgren J, Reinecke H, Roldan-Schilling V, Rowell N, Sinnaeve P, Collins R, Camm AJ, Heidbuchel H; ESC Scientific Document Group. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018 Apr 21;39(16):1330-1393. doi: 10.1093/eurheartj/ehy136.

  PMID: 29562325 BACKGROUND

• Barnes GD, Sippola E, Dorsch M, Errickson J, Lanham M, Allen A, Spoutz P, Sales AE, Sussman J. Applying population health approaches to improve safe anticoagulant use in the outpatient setting: the DOAC Dashboard multi-cohort implementation evaluation study protocol. Implement Sci. 2020 Sep 21;15(1):83. doi: 10.1186/s13012-020-01044-5.

  PMID: 32958020 BACKGROUND

• Sylvester KW, Ting C, Lewin A, Collins P, Fanikos J, Goldhaber SZ, Connors JM. Expanding anticoagulation management services to include direct oral anticoagulants. J Thromb Thrombolysis. 2018 Feb;45(2):274-280. doi: 10.1007/s11239-017-1602-1.

  PMID: 29274044 BACKGROUND

• Andreu Cayuelas JM, Caro Martinez C, Flores Blanco PJ, Elvira Ruiz G, Albendin Iglesias H, Cerezo Manchado JJ, Bailen Lorenzo JL, Januzzi JL, Garcia Alberola A, Manzano-Fernandez S. Kidney function monitoring and nonvitamin K oral anticoagulant dosage in atrial fibrillation. Eur J Clin Invest. 2018 Jun;48(6):e12907. doi: 10.1111/eci.12907. Epub 2018 Apr 22.

  PMID: 29423910 BACKGROUND

• Fava JP, Starr KM, Ratz D, Clemente JL. Dosing challenges with direct oral anticoagulants in the elderly: a retrospective analysis. Ther Adv Drug Saf. 2018 May 17;9(8):405-414. doi: 10.1177/2042098618774498. eCollection 2018 Aug.

  PMID: 30364869 BACKGROUND

• Ashjian E, Kurtz B, Renner E, Yeshe R, Barnes GD. Evaluation of a pharmacist-led outpatient direct oral anticoagulant service. Am J Health Syst Pharm. 2017 Apr 1;74(7):483-489. doi: 10.2146/ajhp151026.

  PMID: 28336758 BACKGROUND

• Kim JJ, Hill HL, Groce JB 3rd, Granfortuna JM, Makhlouf TK. Pharmacy Student Monitoring of Direct Oral Anticoagulants. J Pharm Pract. 2018 Oct;31(5):462-468. doi: 10.1177/0897190017752713. Epub 2018 Jan 24.

  PMID: 29366379 BACKGROUND

• Li X, Zuo C, Lu W, Zou Y, Xu Q, Li X, Lv Q. Evaluation of Remote Pharmacist-Led Outpatient Service for Geriatric Patients on Rivaroxaban for Nonvalvular Atrial Fibrillation During the COVID-19 Pandemic. Front Pharmacol. 2020 Aug 21;11:1275. doi: 10.3389/fphar.2020.01275. eCollection 2020.

  PMID: 32973511 BACKGROUND

• Miele C, Taylor M, Shah A. Assessment of Direct Oral Anticoagulant Prescribing and Monitoring Pre- and Post-Implementation of a Pharmacy Protocol at a Community Teaching Hospital. Hosp Pharm. 2017 Mar;52(3):207-213. doi: 10.1310/hpj5203-207.

  PMID: 28439135 BACKGROUND

• Ertl J, Chalmers L, Bereznicki L. The Quality of Advice Provided by Pharmacists to Patients Taking Direct Oral Anticoagulants: A Mystery Shopper Study. Pharmacy (Basel). 2020 Sep 3;8(3):164. doi: 10.3390/pharmacy8030164.

  PMID: 32899401 BACKGROUND

• Shimizu T, Momose Y, Ogawa R, Takahashi M, Echizen H. Impact of Pharmacists' audit on improving the quality of prescription of dabigatran etexilate methanesulfonate: a retrospective study. J Pharm Health Care Sci. 2017 Jan 17;3:4. doi: 10.1186/s40780-017-0077-8. eCollection 2017.

  PMID: 28116115 BACKGROUND

• Virdee MS, Stewart D. Optimizing the use of oral anticoagulant therapy for atrial fibrilation in primary care: a pharmacist-led intervention. Int J Clin Pharm. 2017 Feb;39(1):173-180. doi: 10.1007/s11096-016-0419-x. Epub 2017 Jan 3.

  PMID: 28050712 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raffaele La Regina, DR

  Farmacia La Regina srl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 21, 2021
• Study Start: October 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)