Atrial FibrillationNACOsNCT03367325
Clinical Decision Support Tool for Improving the Adequacy of Anticoagulant Therapy in Non-valvular Atrial Fibrillation
A study testing CDS-NVAF in people with Atrial Fibrillation and Anticoagulants, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia and increases the risk of ischemic stroke 4-5-fold. The prevention of complications is based on oral or antiplatelet anticoagulant treatment. The first choice of anticoagulant therapy (AT) is the vitamin K antagonist (VKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Anticoagulants, Clinical Decision Support Systems
- What is being tested?
- CDS-NVAF
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63,001 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2017to 15 Dec 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
- Patients diagnosed with NVAF one year prior to the implementation of the computerized tool;
- Patients receiving anticoagulant treatment with DOACs or VKAs;
- Patients followed in primary care (with at least 6 INR controls during the year prior to the intervention).
Who cannot join
- Patients with INR control in the reference hospital;
- patients with valvular AF (mitral stenosis);
- patients with a prosthetic heart valve;
- change to another primary care center.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
Barcelona, 08007
About this study
Official title: A New Clinical Decision Support Tool for Improving the Adequacy of Anticoagulant Therapy and Reduce Stroke Incidence in Non-valvular Atrial Fibrillation: a Randomized Clinical Trial in Primary Care
Atrial fibrillation (AF) is the most common cardiac arrhythmia and increases the risk of ischemic stroke 4-5-fold. The prevention of complications is based on oral or antiplatelet anticoagulant treatment. The first choice of anticoagulant therapy (AT) is the vitamin K antagonist (VKA). Contraindication to VKA or poor control of the International Normalized Ratio leads to the administration of direct-acting oral anticoagulants (DOACs). There is a trend towards inadequate AT in non-valvular AF (NVAF) patients.
The Objective of the study is evaluate the impact of the implementation of a decision support tool linked to digital clinical history on the adequacy of AT, the incidence of complications and the mortality in patients with NVAF in primary health care of the Catalan Institute of Health (ICS).
- Being tested
- CDS-NVAF
- Keywords
- non-valvular atrial fibrillation, time in therapeutic range, primary care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDS-NVAFDevice
The CDS-NVAF is intended for patients diagnosed with NVAF and treated with VKA. This tool calculates the time in the therapeutic range (TTR) using the Rosendaal method considering the last International Normalized Ratio (INR) data. The INR data are found in the clinical history of NVAF patients. The CDS-NVAF will be activated when the physician introduces the last INR value. At this time the TTR will be calculated automatically. If the TTR value is < 65%, a pop up screen with a warning text will open suggesting a change to DOAC therapy. The physician can decide whether to change or not the previous prescription. If the TTR value in > 65% the pop up screen will not appear. The TTR value will remain registered on the screen of the follow up of oral anticoagulant use and can be consulted in future queries. The diffusion of the CDS-NVAF will be made by an announcement on the first day of the intervention when the health care professional opens the electronic clinical history.
| Study group | Role | What they receive |
|---|---|---|
| CDS-NVAF benefiting group | Experimental | CDS-NVAF = Clinical decision support (CDS) tool for improving the adequacy of the anticoagulant therapy adequacy in non-valvular atrial fibrillation (NVAF) Receives: Device: CDS-NVAF |
| CDS-NVAF not-benefiting group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of Thromboembolic events
Thromboembolic events: acute myocardial infarction or angina, ischemic stroke, peripheral embolism or transient ischemic attack (TIA)
Measured: Two years after the beginning of the intervention
Incidence rate of Hemorrhagic events
Hemorrhagic events: intracranial hemorrhage and gastrointestinal hemorrhage
Measured: Two years after the beginning of the intervention
Incidence rate of mortality
All-cause mortality
Measured: Two years after the beginning of the intervention
Adequacy of anticoagulant treatment
This variable encompasses the adequacy of the anticoagulant treatment, taking into account if an adequate change has occurred or not.
0 = No adequate change (when an inadequate change has been produced or when an inadequate treatment has been maintained)
1 = adequate change (when an adequate change has been produced or when an adequate treatment has been maintained) The adequacy of the anticoagulant therapy in patients with NVAF will be based on the fulfillment of the criteria of the Ministry of Health, Social Services and Equality of Spain, 2016*
- Ministry of Health, Social Services and Equality. Criteria and recommendations for the use of direct oral anticoagulants (ACOD) in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. 2016. available in: https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/criterios-anticoagulantes-orales.pdf
Measured: one year after the beginning of the intervention
Secondary outcomes (17)
Sociodemographic characteristics of the patients
age, sex, primary care area assigned, physician assigned
Measured: at the beginning of the intervention
Primary Care Center (PCC) characteristics: teaching center
This variable encompasses if a PCC is a teaching center or not
Measured: at the beginning of the intervention
Primary Care Center (PCC) characteristics: urban/rural
This variable encompasses if a PCC is located at urban o rural area
Measured: at the beginning of the intervention
Primary Care Center (PCC) characteristics: socioeconomic deprivation index (MEDEA)
This variable encompasses the socioeconomic deprivation index (MEDEA) of each PCC
Measured: at the beginning of the intervention
Primary Care Center (PCC) characteristics: Standard of Health Care Quality (SHCQ)
This variable encompasses the Standard of Health Care Quality of each PCC
Measured: at the beginning of the intervention
Primary Care Center (PCC) characteristics: Standard of Quality of Pharmaceutical Prescription (SQPP)
This variable encompasses the Standard of Quality of Pharmaceutical Prescription of each PCC
Measured: at the beginning of the intervention
Characteristics of the professional: age
This variable encompasses the age of the professional
Measured: at the beginning of the intervention
Characteristics of the professional: sex
This variable encompasses the sex of the professional
Measured: at the beginning of the intervention
Characteristics of the professional: PCC
This variable identifies the PCC of the professional
Measured: at the beginning of the intervention
Characteristics of the professional: type of work contract
This variable encompasses the type of work contract of the professional
Measured: at the beginning of the intervention
Characteristics of the professional: Standard of Health Care Quality (SHCQ)
This variable encompasses the Standard of Health Care Quality of the professional
Measured: at the beginning of the intervention
Characteristics of the professional: Standard of Quality of Pharmaceutical Prescription (SQPP)
This variable encompasses the Standard of Quality of Pharmaceutical Prescription of the professional
Measured: at the beginning of the intervention
Treatment by direct-acting oral antagonists
Direct-acting oral antagonists: dabigatran, apixaban or rivaroxaban
Measured: at the beginning of the intervention and one year after the beginning of the intervention
Treatment by Vitamin K antagonists
Vitamin K antagonists: acenocoumarol or warfarin
Measured: at the beginning of the intervention and one year after the beginning of the intervention
Treatment by heparin
presence / absence of heparin treatment
Measured: at the beginning of the intervention and one year after the beginning of the intervention
Thromboembolic risk CHA2DS2-VASC (congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, age 65 to 74 years, female) score
The score indicates the risk of a patient with non-valvular atrial fibrillation of suffering a stroke in one year. The score goes from 0 (absence of risk) to 10 (greater risk).
Measured: at the beginning of the intervention and one year after the beginning of the intervention
Bleeding risk HAS-BLED (Hypertension, Abnormal liver/renal function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), and Drugs/alcohol) score
The score allows the calculation of the risk of bleeding in patients with non-valvular atrial fibrillation receiving oral anticoagulant treatment based on the risk factors associated with the probability of bleeding.
0 = low risk; 1 = intermediate risk; 2 = intermediate risk; ≥3 = high risk
Measured: at the beginning of the intervention and one year after the beginning of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start15 Dec 2017
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 63,001 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut, Department of Health, Generalitat de Catalunya
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367325
- Sponsor's protocol ID
- SLT002/16/00146
- Acronym
- NACOs
- Status last verified
- Dec 2018
- First submitted
- 20 Nov 2017
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dalmau Llorca MR, Aguilar Martin C, Carrasco-Querol N, Hernandez Rojas Z, Rodriguez Cumplido D, Castro Blanco E, Queiroga Goncalves A, Fernandez-Saez J, Perez-Villacastin J. Clinical value of a tool for managing oral anticoagulation in nonvalvular atrial fibrillation in primary health care. Randomized clinical trial. Rev Esp Cardiol (Engl Ed). 2024 Jun;77(6):471-480. doi: 10.1016/j.rec.2023.11.009. Epub 2023 Dec 4. English, Spanish.
PubMed 38056770Dalmau Llorca MR, Goncalves AQ, Forcadell Drago E, Fernandez-Saez J, Hernandez Rojas Z, Pepio Vilaubi JM, Rodriguez Cumplido D, Morral Parente RM, Aguilar Martin C. A new clinical decision support tool for improving the adequacy of anticoagulant therapy and reducing the incidence of stroke in nonvalvular atrial fibrillation: A randomized clinical trial in primary care. Medicine (Baltimore). 2018 Jan;97(3):e9578. doi: 10.1097/MD.0000000000009578.
PubMed 29504981
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Clinical Decision Support Tool for Improving the Adequacy of Anticoagulant Therapy and Reduce Stroke Incidence in Non-valvular Atrial Fibrillation: a Randomized Clinical Trial in Primary Care
- ClinicalTrials.gov ID
- NCT03367325
- Acronym / sponsor ID
- NACOs / SLT002/16/00146
- Keywords
- non-valvular atrial fibrillation, time in therapeutic range, primary care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63,001 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut, Department of Health, Generalitat de Catalunya
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 8 Dec 2017 (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.
Atrial fibrillation (AF) is the most common cardiac arrhythmia and increases the risk of ischemic stroke 4-5-fold. The prevention of complications is based on oral or antiplatelet anticoagulant treatment. The first choice of anticoagulant therapy (AT) is the vitamin K antagonist (VKA). Contraindication to VKA or poor control of the International Normalized Ratio leads to the administration of direct-acting oral anticoagulants (DOACs). There is a trend towards inadequate AT in non-valvular AF (NVAF) patients.
The Objective of the study is evaluate the impact of the implementation of a decision support tool linked to digital clinical history on the adequacy of AT, the incidence of complications and the mortality in patients with NVAF in primary health care of the Catalan Institute of Health (ICS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDS-NVAF benefiting group | Experimental | Device: CDS-NVAFCDS-NVAF = Clinical decision support (CDS) tool for improving the adequacy of the anticoagulant therapy adequacy in non-valvular atrial fibrillation (NVAF) |
| CDS-NVAF not-benefiting group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with NVAF one year prior to the implementation of the computerized tool;
- Patients receiving anticoagulant treatment with DOACs or VKAs;
- Patients followed in primary care (with at least 6 INR controls during the year prior to the intervention).
Key exclusion criteria (4 listed)
- Patients with INR control in the reference hospital;
- patients with valvular AF (mitral stenosis);
- patients with a prosthetic heart valve;
- change to another primary care center.
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 |
|---|---|---|
| CDS-NVAFThe CDS-NVAF is intended for patients diagnosed with NVAF and treated with VKA. This tool calculates the time in the therapeutic range (TTR) using the Rosendaal method considering the last International Normalized Ratio (INR) data. The INR data are found in the clinical history of NVAF patients. The CDS-NVAF will be activated when the physician introduces the last INR value. At this time the TTR will be calculated automatically. If the TTR value is < 65%, a pop up screen with a warning text will open suggesting a change to DOAC therapy. The physician can decide whether to change or not the previous prescription. If the TTR value in > 65% the pop up screen will not appear. The TTR value will remain registered on the screen of the follow up of oral anticoagulant use and can be consulted in future queries. The diffusion of the CDS-NVAF will be made by an announcement on the first day of the intervention when the health care professional opens the electronic clinical history. | Device | CDS-NVAF benefiting group |
Primary outcome
Incidence rate of Thromboembolic events
Time frame: Two years after the beginning of the intervention
Thromboembolic events: acute myocardial infarction or angina, ischemic stroke, peripheral embolism or transient ischemic attack (TIA)
Incidence rate of Hemorrhagic events
Time frame: Two years after the beginning of the intervention
Hemorrhagic events: intracranial hemorrhage and gastrointestinal hemorrhage
Incidence rate of mortality
Time frame: Two years after the beginning of the intervention
All-cause mortality
Adequacy of anticoagulant treatment
Time frame: one year after the beginning of the intervention
This variable encompasses the adequacy of the anticoagulant treatment, taking into account if an adequate change has occurred or not. 0 = No adequate change (when an inadequate change has been produced or when an inadequate treatment has been maintained) 1 = adequate change (when an adequate change has been produced or when an adequate treatment has been maintained) The adequacy of the anticoagulant therapy in patients with NVAF will be based on the fulfillment of the criteria of the Ministry of Health, Social Services and Equality of Spain, 2016* * Ministry of Health, Social Services and Equality. Criteria and recommendations for the use of direct oral anticoagulants (ACOD) in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. 2016. available in: https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/criterios-anticoagulantes-orales.pdf
17 secondary outcomes
Sociodemographic characteristics of the patients
Time frame: at the beginning of the intervention
Primary Care Center (PCC) characteristics: teaching center
Time frame: at the beginning of the intervention
Primary Care Center (PCC) characteristics: urban/rural
Time frame: at the beginning of the intervention
Primary Care Center (PCC) characteristics: socioeconomic deprivation index (MEDEA)
Time frame: at the beginning of the intervention
Primary Care Center (PCC) characteristics: Standard of Health Care Quality (SHCQ)
Time frame: at the beginning of the intervention
Primary Care Center (PCC) characteristics: Standard of Quality of Pharmaceutical Prescription (SQPP)
Time frame: at the beginning of the intervention
Characteristics of the professional: age
Time frame: at the beginning of the intervention
Characteristics of the professional: sex
Time frame: at the beginning of the intervention
Characteristics of the professional: PCC
Time frame: at the beginning of the intervention
Characteristics of the professional: type of work contract
Time frame: at the beginning of the intervention
Characteristics of the professional: Standard of Health Care Quality (SHCQ)
Time frame: at the beginning of the intervention
Characteristics of the professional: Standard of Quality of Pharmaceutical Prescription (SQPP)
Time frame: at the beginning of the intervention
Treatment by direct-acting oral antagonists
Time frame: at the beginning of the intervention and one year after the beginning of the intervention
Treatment by Vitamin K antagonists
Time frame: at the beginning of the intervention and one year after the beginning of the intervention
Treatment by heparin
Time frame: at the beginning of the intervention and one year after the beginning of the intervention
Thromboembolic risk CHA2DS2-VASC (congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, age 65 to 74 years, female) score
Time frame: at the beginning of the intervention and one year after the beginning of the intervention
Bleeding risk HAS-BLED (Hypertension, Abnormal liver/renal function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), and Drugs/alcohol) score
Time frame: at the beginning of the intervention and one year after the beginning of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Derived from this study: PubMed 38056770Dalmau Llorca MR, Aguilar Martin C, Carrasco-Querol N, Hernandez Rojas Z, Rodriguez Cumplido D, Castro Blanco E, Queiroga Goncalves A, Fernandez-Saez J, Perez-Villacastin J. Clinical value of a tool for managing oral anticoagulation in nonvalvular atrial fibrillation in primary health care. Randomized clinical trial. Rev Esp Cardiol (Engl Ed). 2024 Jun;77(6):471-480. doi: 10.1016/j.rec.2023.11.009. Epub 2023 Dec 4. English, Spanish.
- Derived from this study: PubMed 29504981Dalmau Llorca MR, Goncalves AQ, Forcadell Drago E, Fernandez-Saez J, Hernandez Rojas Z, Pepio Vilaubi JM, Rodriguez Cumplido D, Morral Parente RM, Aguilar Martin C. A new clinical decision support tool for improving the adequacy of anticoagulant therapy and reducing the incidence of stroke in nonvalvular atrial fibrillation: A randomized clinical trial in primary care. Medicine (Baltimore). 2018 Jan;97(3):e9578. doi: 10.1097/MD.0000000000009578.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDS-NVAF in people with Atrial Fibrillation and Anticoagulants, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Incidence rate of Thromboembolic events (time frame: Two years after the beginning of the intervention). The study lists 4 primary outcomes in all. 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 NCT03367325, which also lists 2 linked publications.
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 21 Dec 2018.