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

NCT06100380 | Completed

• 1 other identifier: PO20162*
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolic Event

Outcome Measures

Primary Outcomes (1)

• Number of thromboembolic event in patients treated with an oral anticoagulant

  1 day

Study Arms (2)

patients with Thromboembolic event and Hemorrhage group

patients who present a hemorrhage or a thromboembolic event

Other: Survey

patients without Thromboembolic event and Hemorrhage

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

Other: Survey

Interventions

Survey OTHER

Questionnaire

patients with Thromboembolic event and Hemorrhage group; patients without Thromboembolic event and Hemorrhage

Eligibility Criteria

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

Study Population

Patients will be selected during their hospitalization at University hospital of Reims if they are treated with an oral anticoagulant.

You may qualify if:

• 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.

You may not qualify if:

• 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 discharged from hospital before having answering the surveys.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Thromboembolism

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: October 25, 2023
• Study Start: September 20, 2020
• Primary Completion: November 17, 2021
• Study Completion: October 1, 2023
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

FR (1)