Antithrombotics PrescriptionsCOMBI-ATNCT03630874
A Prescription Support Tool for Oral Antithrombotic Combinations
A study testing Evaluate the impact of a prescription support tool in people with Antithrombotics Prescriptions, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antithrombotics Prescriptions
- What is being tested?
- Evaluate the impact of a prescription support tool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2018to 14 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- French practicing physicians who are involved in outpatient settings, including general practitioners and cardiologists.
Who cannot join
- Physicians with an exclusive hospital practice.
About this study
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
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.
Read the 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
- Being tested
- Evaluate the impact of a prescription support tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the impact of a prescription support toolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Other: Evaluate the impact of a prescription support tool |
| Control arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day one
Secondary outcomes (2)
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.
Measured: 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?"
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start5 Nov 2018
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antithrombotics PrescriptionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Sorbonne University, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Lorène ZERAH, M.D, Principal investigator, APHP / INSERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630874
- Sponsor's protocol ID
- 18-492
- Acronym
- COMBI-AT
- Status last verified
- Jul 2018
- First submitted
- 9 Jul 2018
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31182442
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03630874
- Acronym / sponsor ID
- COMBI-AT / 18-492
- Conditions
- Antithrombotics Prescriptions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Sorbonne University, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Evaluate the impact of a prescription support tool |
| Control arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- French practicing physicians who are involved in outpatient settings, including general practitioners and cardiologists.
Key exclusion criteria (1 listed)
- Physicians with an exclusive hospital practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate the impact of a prescription support toolFrom 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. | Other | Experimental arm |
Primary outcome
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.
Time frame: Day one
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.
2 secondary outcomes
The rate of the "right prescription of oral ATs" performed by physicians' specialty.
Time frame: 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.
Time frame: Day one
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Derived from this study: PubMed 31182442Zerah 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorène ZERAH, M.D principal investigator
APHP / INSERM
Questions about this trial
What is this clinical trial studying?
A study testing Evaluate the impact of a prescription support tool in people with Antithrombotics Prescriptions, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.