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

Atrial Fibrillation Clinical Trial

— NACOs  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03367325
• Other study ID #: SLT002/16/00146
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: December 15, 2019

Study information

• Verified date: December 2018
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63001
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anticoagulants
• Atrial Fibrillation
• Clinical Decision Support Systems

Intervention

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.

Locations

Country	Name	City	State
Spain	Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Department of Health, Generalitat de Catalunya, Institut Català de la Salut

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of Thromboembolic events	Thromboembolic events: acute myocardial infarction or angina, ischemic stroke, peripheral embolism or transient ischemic attack (TIA)	Two years after the beginning of the intervention
Primary	Incidence rate of Hemorrhagic events	Hemorrhagic events: intracranial hemorrhage and gastrointestinal hemorrhage	Two years after the beginning of the intervention
Primary	Incidence rate of mortality	All-cause mortality	Two years after the beginning of the intervention
Primary	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	one year after the beginning of the intervention
Secondary	Sociodemographic characteristics of the patients	age, sex, primary care area assigned, physician assigned	at the beginning of the intervention
Secondary	Primary Care Center (PCC) characteristics: teaching center	This variable encompasses if a PCC is a teaching center or not	at the beginning of the intervention
Secondary	Primary Care Center (PCC) characteristics: urban/rural	This variable encompasses if a PCC is located at urban o rural area	at the beginning of the intervention
Secondary	Primary Care Center (PCC) characteristics: socioeconomic deprivation index (MEDEA)	This variable encompasses the socioeconomic deprivation index (MEDEA) of each PCC	at the beginning of the intervention
Secondary	Primary Care Center (PCC) characteristics: Standard of Health Care Quality (SHCQ)	This variable encompasses the Standard of Health Care Quality of each PCC	at the beginning of the intervention
Secondary	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	at the beginning of the intervention
Secondary	Characteristics of the professional: age	This variable encompasses the age of the professional	at the beginning of the intervention
Secondary	Characteristics of the professional: sex	This variable encompasses the sex of the professional	at the beginning of the intervention
Secondary	Characteristics of the professional: PCC	This variable identifies the PCC of the professional	at the beginning of the intervention
Secondary	Characteristics of the professional: type of work contract	This variable encompasses the type of work contract of the professional	at the beginning of the intervention
Secondary	Characteristics of the professional: Standard of Health Care Quality (SHCQ)	This variable encompasses the Standard of Health Care Quality of the professional	at the beginning of the intervention
Secondary	Characteristics of the professional: Standard of Quality of Pharmaceutical Prescription (SQPP)	This variable encompasses the Standard of Quality of Pharmaceutical Prescription of the professional	at the beginning of the intervention
Secondary	Treatment by direct-acting oral antagonists	Direct-acting oral antagonists: dabigatran, apixaban or rivaroxaban	at the beginning of the intervention and one year after the beginning of the intervention
Secondary	Treatment by Vitamin K antagonists	Vitamin K antagonists: acenocoumarol or warfarin	at the beginning of the intervention and one year after the beginning of the intervention
Secondary	Treatment by heparin	presence / absence of heparin treatment	at the beginning of the intervention and one year after the beginning of the intervention
Secondary	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).	at the beginning of the intervention and one year after the beginning of the intervention
Secondary	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	at the beginning of the intervention and one year after the beginning of the intervention