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Clinical Decision Support Tool for Improving the Adequacy of Anticoagulant Therapy in Non-valvular Atrial Fibrillation (NACOs)

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ClinicalTrials.gov Identifier: NCT03367325
Recruitment Status : Active, not recruiting
First Posted : December 8, 2017
Last Update Posted : December 21, 2018
Sponsor:
Collaborators:
Institut Català de la Salut
Department of Health, Generalitat de Catalunya
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief 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). 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).


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Anticoagulants Clinical Decision Support Systems Device: CDS-NVAF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63001 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CDS-NVAF benefiting group
CDS-NVAF = Clinical decision support (CDS) tool for improving the adequacy of the anticoagulant therapy adequacy in non-valvular atrial fibrillation (NVAF)
Device: CDS-NVAF
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.

No Intervention: CDS-NVAF not-benefiting group



Primary Outcome Measures :
  1. 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)

  2. Incidence rate of Hemorrhagic events [ Time Frame: Two years after the beginning of the intervention ]
    Hemorrhagic events: intracranial hemorrhage and gastrointestinal hemorrhage

  3. Incidence rate of mortality [ Time Frame: Two years after the beginning of the intervention ]
    All-cause mortality

  4. 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



Secondary Outcome Measures :
  1. Sociodemographic characteristics of the patients [ Time Frame: at the beginning of the intervention ]
    age, sex, primary care area assigned, physician assigned

  2. Primary Care Center (PCC) characteristics: teaching center [ Time Frame: at the beginning of the intervention ]
    This variable encompasses if a PCC is a teaching center or not

  3. Primary Care Center (PCC) characteristics: urban/rural [ Time Frame: at the beginning of the intervention ]
    This variable encompasses if a PCC is located at urban o rural area

  4. Primary Care Center (PCC) characteristics: socioeconomic deprivation index (MEDEA) [ Time Frame: at the beginning of the intervention ]
    This variable encompasses the socioeconomic deprivation index (MEDEA) of each PCC

  5. Primary Care Center (PCC) characteristics: Standard of Health Care Quality (SHCQ) [ Time Frame: at the beginning of the intervention ]
    This variable encompasses the Standard of Health Care Quality of each PCC

  6. Primary Care Center (PCC) characteristics: Standard of Quality of Pharmaceutical Prescription (SQPP) [ Time Frame: at the beginning of the intervention ]
    This variable encompasses the Standard of Quality of Pharmaceutical Prescription of each PCC

  7. Characteristics of the professional: age [ Time Frame: at the beginning of the intervention ]
    This variable encompasses the age of the professional

  8. Characteristics of the professional: sex [ Time Frame: at the beginning of the intervention ]
    This variable encompasses the sex of the professional

  9. Characteristics of the professional: PCC [ Time Frame: at the beginning of the intervention ]
    This variable identifies the PCC of the professional

  10. Characteristics of the professional: type of work contract [ Time Frame: at the beginning of the intervention ]
    This variable encompasses the type of work contract of the professional

  11. Characteristics of the professional: Standard of Health Care Quality (SHCQ) [ Time Frame: at the beginning of the intervention ]
    This variable encompasses the Standard of Health Care Quality of the professional

  12. Characteristics of the professional: Standard of Quality of Pharmaceutical Prescription (SQPP) [ Time Frame: at the beginning of the intervention ]
    This variable encompasses the Standard of Quality of Pharmaceutical Prescription of the professional

  13. Treatment by direct-acting oral antagonists [ Time Frame: at the beginning of the intervention and one year after the beginning of the intervention ]
    Direct-acting oral antagonists: dabigatran, apixaban or rivaroxaban

  14. Treatment by Vitamin K antagonists [ Time Frame: at the beginning of the intervention and one year after the beginning of the intervention ]
    Vitamin K antagonists: acenocoumarol or warfarin

  15. Treatment by heparin [ Time Frame: at the beginning of the intervention and one year after the beginning of the intervention ]
    presence / absence of heparin treatment

  16. 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 ]
    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).

  17. 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 ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (all criteria must be met):

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367325


Locations
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Spain
Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
Barcelona, Spain, 08007
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Institut Català de la Salut
Department of Health, Generalitat de Catalunya

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03367325     History of Changes
Other Study ID Numbers: SLT002/16/00146
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordi Gol i Gurina Foundation:
non-valvular atrial fibrillation
time in therapeutic range
primary care
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants