Atrial FibrillationAIHEMAF - PNCT05086991
AIHEMAF - P "An Innovative Healthcare Model for AF Patients"
An observational study of Atrial Fibrillation, run by Farmacia La Regina s.r.l. at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Follow up
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2021to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering from Non-Valvular Atrial Fibrillation and being treated with new generation oral anticoagulants;
Who may be able to join
- 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.
Who cannot join
- Nobody
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Follow up
- Keywords
- adherence, therapy, follow up, community pharmacy, pharmacist, case manager, telemedicine, pharmacy of service, pharmacological therapy check, ecg, general physician, Cardiology Specialist, Doac, Noac
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow upOther
like group descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Percent of Participants With Adherence to the PDTA
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".
Measured: 12 months
Prescriptive appropriateness
detection of the number of cases in which the therapy must be changed (molecule or dosage) or suspended because it is not appropriate
Measured: 12 months
Adherence to therapy
detection of cases in which the therapy was not followed correctly
Measured: 12 months
Pharmacological problems
detection of cases in which drug therapy needs to be revised due to drug-drug interactions
Measured: 12 months
Bleeding and / or thrombo-embolic complications;
detection of cases of bleeding and / or thrombo-embolic complications
Measured: 12 months
Acceptance of reports
detection of cases in which the general practitioner or specialist doctor accepts the reports of the pharmacist
Measured: 12 months
Economic Impact
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Oct 2021
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farmacia La Regina s.r.l.
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Superiore di Sanità, Università degli Studi di Brescia, Nova Biomedical Italia s.r.l., Health Telematic Network, Centro Studi Federfarma
- Responsible party
- Sponsor
- Investigators
- Raffaele La Regina, DR, Principal investigator, Farmacia La Regina srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086991
- Sponsor's protocol ID
- 2
- Acronym
- AIHEMAF - P
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared only in aggregate and anonymous form.
Publications
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.
PubMed 33242070Steffel 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.
PubMed 29562325Barnes 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.
PubMed 32958020Sylvester 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.
PubMed 29274044Andreu 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.
PubMed 29423910Fava 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.
PubMed 30364869Ashjian 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.
PubMed 28336758Kim 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.
PubMed 29366379Li 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.
PubMed 32973511Miele 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.
PubMed 28439135Ertl 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.
PubMed 32899401Shimizu 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.
PubMed 28116115Virdee 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.
PubMed 28050712
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05086991
- Acronym / sponsor ID
- AIHEMAF - P / 2
- Conditions
- Atrial Fibrillation
- Keywords
- adherence, therapy, follow up, community pharmacy, pharmacist, case manager, telemedicine, pharmacy of service
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Farmacia La Regina s.r.l.University, hospital or other
- Collaborators
- Istituto Superiore di Sanità, Università degli Studi di Brescia, Nova Biomedical Italia s.r.l., Health Telematic Network, Centro Studi Federfarma
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Study | – | Other: Follow upFollow 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from Non-Valvular Atrial Fibrillation and being treated with new generation oral anticoagulants;
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Nobody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow uplike group descriptions | Other | Group Study |
Primary outcome
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.
7 secondary outcomes
Percent of Participants With Adherence to the PDTA
Time frame: 12 months
Prescriptive appropriateness
Time frame: 12 months
Adherence to therapy
Time frame: 12 months
Pharmacological problems
Time frame: 12 months
Bleeding and / or thrombo-embolic complications;
Time frame: 12 months
Acceptance of reports
Time frame: 12 months
Economic Impact
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 33242070Corrigendum 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.
- Background: PubMed 29562325Steffel 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.
- Background: PubMed 32958020Barnes 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.
- Background: PubMed 29274044Sylvester 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.
- Background: PubMed 29423910Andreu 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.
- Background: PubMed 30364869Fava 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.
- Background: PubMed 28336758Ashjian 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.
- Background: PubMed 29366379Kim 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.
- Background: PubMed 32973511Li 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.
- Background: PubMed 28439135Miele 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.
- Background: PubMed 32899401Ertl 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.
- Background: PubMed 28116115Shimizu 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.
- Individual participant dataSharing planned: No. The data will be shared only in aggregate and anonymous form.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele La Regina, DR principal investigator
Farmacia La Regina srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Farmacia La Regina s.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Model implementation description (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05086991, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.