A Prescription Support Tool for Oral Antithrombotic Combinations

NCT ID: NCT03630874

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 478 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2019-02-14

Brief Summary

From a systematic review of international guidelines (2012-2018), a prescription support-tool synthesizing national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy will be developed. Guidelines dealing with the use of oral ATs for non-valvular atrial fibrillation, coronary artery disease, ischemic stroke, valvular heart disease, peripheral artery disease and venous thromboembolism in adults will be included. These pathologies were selected because most prescriptions of ATs are related to neuro-cardiovascular diseases and because this study would provide a synthesis relevant for clinicians in charge of the follow-up of patients with oral AT combinations. Studies are needed to assess the impact of this tool on appropriate prescribing.

Detailed Description

Oral antithrombotic (AT) drugs are widely implicated in serious and preventable bleeding events, which justifies the implementation of risk minimization actions. Avoiding inappropriate oral AT combinations is a major concern, particularly for patients with multiple chronic conditions. The first step is to provide fast and easy access to the latest recommendations. From a systematic review of international guidelines (2012-2018), a prescription support-tool synthesizing national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy will be developed. Our main objective in this study is to evaluate the accuracy of this tool by measuring the appropriateness of oral AT prescriptions according to the most recent guidelines.

Methods and analysis: In this web-based randomized controlled trial, participating French general practitioners and cardiologists in the outpatient setting will be randomized by use or not of the prescription support-tool. They will be asked to provide the number of drugs, drug class, duration and dosage of ATs, within a time window of 10 minutes, for 3 different clinical situations presented as clinical vignettes (multiple-choice questions). The scientific committee has created and validated 30 clinical vignettes illustrating outpatient clinical situations for which the use of oral ATs (single, dual or triple therapy) is recommended or not according to the guidelines. All data will be treated anonymously.

Ethics and dissemination: If the prescription support-tool is associated with more appropriate prescription of AT combinations, its dissemination to further evaluate outcome data including haemorrhage, ischemic events, and death will be considered.

Conditions

Antithrombotics Prescriptions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental arm

Group Type: EXPERIMENTAL

Evaluate the impact of a prescription support tool

Intervention Type: OTHER

From a systematic review of international guidelines (2012-2018), we developed a prescription support-tool synthesizing national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy.

In the experimental group, the tool will be provided with an explanatory guide. Selected physicians will receive 3 different clinical vignettes, each corresponding to a specific situation for which the physician will have to indicate (thanks to the tool) the "right prescription" of ATs by answering a multiple-choice question, with the number, type, duration and dosage of AT provided.

Control arm

Selected physicians will receive 3 different clinical vignettes, each corresponding to a specific situation for which the physician will have to indicate (without the tool) the "right prescription" of ATs by answering a multiplechoice question, with the number, type, duration and dosage of AT provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Evaluate the impact of a prescription support tool

From a systematic review of international guidelines (2012-2018), we developed a prescription support-tool synthesizing national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy.

In the experimental group, the tool will be provided with an explanatory guide. Selected physicians will receive 3 different clinical vignettes, each corresponding to a specific situation for which the physician will have to indicate (thanks to the tool) the "right prescription" of ATs by answering a multiple-choice question, with the number, type, duration and dosage of AT provided.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• French practicing physicians who are involved in outpatient settings, including general practitioners and cardiologists.

Exclusion Criteria

• Physicians with an exclusive hospital practice.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorbonne University

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorène ZERAH, M.D

Role: PRINCIPAL_INVESTIGATOR

APHP / INSERM

References

Zerah L, Bonnet-Zamponi D, Frappe P, Hauguel-Moreau M, De Rycke Y, Magnier AM, Pautas E, Charles P, Collet JP, Dechartres A, Tubach F. Evaluation of a prescription support-tool for chronic management of oral antithrombotic combinations in adults using clinical vignettes: protocol of a randomised controlled trial. BMJ Open. 2019 Jun 9;9(6):e025544. doi: 10.1136/bmjopen-2018-025544.

Reference Type: DERIVED

PMID: 31182442 (View on PubMed)

Other Identifiers

18-492

Identifier Type: -

Identifier Source: org_study_id