A Prescription Support Tool for Oral Antithrombotic Combinations (COMBI-AT)

Evaluation of a Prescription Support-tool for Chronic Management of Oral Antithrombotic Combinations in Adults: Protocol of a Randomized Controlled Trial Using Clinical Vignettes

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.

Study Overview

• Status: Completed
• Conditions: Antithrombotics Prescriptions
• Intervention / Treatment: Other: Evaluate the impact of a prescription support tool

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.

• Study Type: Interventional
• Enrollment (Actual): 478
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Physicians with an exclusive hospital practice.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental arm	Other: 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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	How will be defined the "right prescription of oral ATs" : From a systematic review of international guidelines (2012-2018), has been developed, a prescription support-tool synthesizing 70 national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy. The scientific committee of this study (cardiologist, internist-geriatricians, general practitioner and epidemiologists) created and validated 30 clinical vignettes. The expert committee of this study had to review all clinical vignettes with the prescription support-tool (external validation) to confirm their agreement with clinical practice and their readability. Thus, the "right prescription of oral ATs" was defined a priori (right or false) thanks to the prescription support tool and validated by the expert committee and the scientific committee.	Day one

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of the "right prescription of oral ATs" performed by physicians' specialty.	Physicians' specialty: french physicians who are involved in outpatient settings, including general practitioners and cardiologists. Physicians with an exclusive hospital practice will not be considered.	Day one
The difference between the control and intervention groups in the degree of confidence physicians have in their AT prescriptions in line with the guidelines.	The degree of confidence was defined a priori with this question: "On a scale of 0 to 10, what is your degree of confidence in the adequacy of your prescription in relation to the guidelines?"	Day one

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Sorbonne University
• Investigators: Principal Investigator: Lorène ZERAH, M.D, APHP / INSERM

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2018
• Primary Completion (ACTUAL): February 14, 2019
• Study Completion (ACTUAL): February 14, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (ACTUAL): August 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 18-492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No