Elaboration of a Prioritization Score for Pharmaceutical Interviews in Patients Treated With Oral Anticoagulants

Sponsor
CHU de Reims (Other)
Overall Status
Completed
CT.gov ID
NCT06100380
Collaborator
(none)
197
1
36.3
5.4

Study Details

Study Description

Brief Summary

Oral anticoagulants have a prominent place in the strategy of prevention and treatment of thromboembolic diseases, especially in patients with atrial fibrillation. However, a study conducted by the National Fund for Health Insurance (Caisse primaire d'Assurance maladie, CPAM) in 2017 among nearly 35,000 patients with non-valvular atrial fibrillation showed that one in five patients stopped their oral anticoagulant without medical advice for at least 60 days during the first year of treatment.

In our establishment, patients hospitalized in the Cardiology departments and treated with oral anticoagulants benefit from pharmaceutical interviews on their treatment before they return at home. This activity, which exists since November 2014, is based on a team consisting on a pharmacy student, supervised by a pharmacist trained in therapeutic education.

In order to secure the management of patients treated by oral anticoagulants and to answer the requirements of Certification, the investigators wish to extend the pharmaceutical interviews to all of hospital's healthcare services. However, the large number of patients concerned, the shorter hospital stays and the difficulties to organize collective sessions in front of the diversity of treatments and diseases are parameters to be taken into account in the development of this activity. The provision of a targeting tool for patients with high risk of thromboembolism and / or hemorrhage is a prerequisite for organizing this institutional approach to support patients on anticoagulants.

In this context, the investigators want to establish a prioritization score to identify patients on oral anticoagulants with a higher drug risk.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey

Detailed Description

Oral anticoagulants are represented by two classes: vitamin K antagonists (VKA) and non-VKA oral anticoagulants (DOAC). They have a prominent place in the strategy of prevention and treatment of thromboembolic diseases, especially in patients with atrial fibrillation. Their prescription continues to increase in France.

However, a study conducted by the National Fund for Health Insurance (Caisse primaire d'Assurance maladie, CPAM) in 2017 among nearly 35,000 patients with non-valvular atrial fibrillation showed that one in five patients stopped their oral anticoagulant without medical advice for at least 60 days during the first year of treatment.

In our establishment, patients hospitalized in the Cardiology departments and treated with oral anticoagulants benefit from pharmaceutical interviews on their treatment before they return at home. This activity, which exists since November 2014, is based on a team consisting on a pharmacy student, supervised by a pharmacist trained in therapeutic education.

In order to secure the management of patients treated by oral anticoagulants and to answer the requirements of Certification, he investigators wish to extend the pharmaceutical interviews to all of hospital's healthcare services. However, the large number of patients concerned, the shorter hospital stays and the difficulties to organize collective sessions in front of the diversity of treatments and diseases are parameters to be taken into account in the development of this activity. The provision of a targeting tool for patients with high risk of thromboembolism and / or hemorrhage is a prerequisite for organizing this institutional approach to support patients on anticoagulants.

In this context, the investigators want to establish a prioritization score to identify patients on oral anticoagulants with a higher drug risk. Case-control study was performed at University hospital of Reims.

Study Design

Study Type:
Observational
Actual Enrollment :
197 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Elaboration of a Prioritization Score for Pharmaceutical Interviews in Patients Treated With Oral Anticoagulants
Actual Study Start Date :
Sep 20, 2020
Actual Primary Completion Date :
Nov 17, 2021
Actual Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
patients with Thromboembolic event and Hemorrhage group

patients who present a hemorrhage or a thromboembolic event

Other: Survey
Questionnaire

patients without Thromboembolic event and Hemorrhage

patients who don't present a hemorrhage or a thromboembolic event

Other: Survey
Questionnaire

Outcome Measures

Primary Outcome Measures

  1. thromboembolic event in patients treated with an oral anticoagulant [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • For the case-subjects:

  • Patient hospitalized at the Reims university hospital

  • Patient treated with an oral anticoagulant (vitamin K antagonist: VKA or non-VKA oral anticoagulant: DOAC) since at least one month

  • Patient with a serious hemorrhage or a thromboembolic event.

  • For the control-subjects:

  • Patient hospitalized at the Reims university hospital

  • Patient treated with an oral anticoagulant (vitamin K antagonist: VKA or non-VKA oral anticoagulant: DOAC) since at least one month

  • Without a serious hemorrhage or a thromboembolic event.

Exclusion Criteria:
  • Patient physically or mentally not able to express non-opposition or opposition to the study;

  • Patient protected by law;

  • Patient physically or mentally not able to answer the surveys;

  • Patient hospitalized in the month preceding the inclusion;

  • Patient discharged from hospital before having answering the surveys.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Reims Reims France 51092

Sponsors and Collaborators

  • CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CHU de Reims
ClinicalTrials.gov Identifier:
NCT06100380
Other Study ID Numbers:
  • PO20162*
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2023