Clinical trial NCT03630874: A Prescription Support Tool for Oral Antithrombotic Combinations
Official title: Evaluation of a Prescription Support-tool for Chronic Management of Oral Antithrombotic Combinations in Adults: Protocol of a Randomized Controlled Trial Using Clinical Vignettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antithrombotics Prescriptions
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Sorbonne University
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2018-08-15
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The primary outcome measure is the rate of the "right prescription of oral ATs" as defined according to the guidelines in terms of number, class, duration and dosage between the two groups.
timeFrame: Day one
Secondary outcomes:
measure: The rate of the "right prescription of oral ATs" performed by physicians' specialty.
timeFrame: Day one
measure: The difference between the control and intervention groups in the degree of confidence physicians have in their AT prescriptions in line with the guidelines.
timeFrame: Day one
Other outcomes:
Locations:
Study officials:
affiliation: APHP / INSERM
name: Lorène ZERAH, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.