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

Not Applicable

• Conditions: Anticoagulants; Atrial Fibrillation; Clinical Decision Support Systems
• Interventions: Device: CDS-NVAF

• Registration Number: NCT03367325
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Study Start: 2017-12-15
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63001

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDS-NVAF benefiting group	CDS-NVAF	CDS-NVAF = Clinical decision support (CDS) tool for improving the adequacy of the anticoagulant therapy adequacy in non-valvular atrial fibrillation (NVAF)

Primary Outcome Measures

Name	Time	Method
Adequacy of anticoagulant treatment	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
Incidence rate of mortality	Two years after the beginning of the intervention	All-cause mortality
Incidence rate of Thromboembolic events	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	Two years after the beginning of the intervention	Hemorrhagic events: intracranial hemorrhage and gastrointestinal hemorrhage

Secondary Outcome Measures

Name	Time	Method
Primary Care Center (PCC) characteristics: teaching center	at the beginning of the intervention	This variable encompasses if a PCC is a teaching center or not
Sociodemographic characteristics of the patients	at the beginning of the intervention	age, sex, primary care area assigned, physician assigned
Primary Care Center (PCC) characteristics: Standard of Health Care Quality (SHCQ)	at the beginning of the intervention	This variable encompasses the Standard of Health Care Quality of each PCC
Characteristics of the professional: sex	at the beginning of the intervention	This variable encompasses the sex of the professional
Characteristics of the professional: Standard of Health Care Quality (SHCQ)	at the beginning of the intervention	This variable encompasses the Standard of Health Care Quality of the professional
Treatment by direct-acting oral antagonists	at the beginning of the intervention and one year after the beginning of the intervention	Direct-acting oral antagonists: dabigatran, apixaban or rivaroxaban
Treatment by Vitamin K antagonists	at the beginning of the intervention and one year after the beginning of the intervention	Vitamin K antagonists: acenocoumarol or warfarin
Primary Care Center (PCC) characteristics: urban/rural	at the beginning of the intervention	This variable encompasses if a PCC is located at urban o rural area
Primary Care Center (PCC) characteristics: socioeconomic deprivation index (MEDEA)	at the beginning of the intervention	This variable encompasses the socioeconomic deprivation index (MEDEA) of each PCC
Characteristics of the professional: age	at the beginning of the intervention	This variable encompasses the age of the professional
Characteristics of the professional: type of work contract	at the beginning of the intervention	This variable encompasses the type of work contract of the professional
Primary Care Center (PCC) characteristics: Standard of Quality of Pharmaceutical Prescription (SQPP)	at the beginning of the intervention	This variable encompasses the Standard of Quality of Pharmaceutical Prescription of each PCC
Characteristics of the professional: PCC	at the beginning of the intervention	This variable identifies the PCC of the professional
Characteristics of the professional: Standard of Quality of Pharmaceutical Prescription (SQPP)	at the beginning of the intervention	This variable encompasses the Standard of Quality of Pharmaceutical Prescription of the professional
Treatment by heparin	at the beginning of the intervention and one year after the beginning of the intervention	presence / absence of heparin treatment
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	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).
Bleeding risk HAS-BLED (Hypertension, Abnormal liver/renal function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), and Drugs/alcohol) score	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

Trial Locations

Locations (1)

Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol); 🇪🇸 Barcelona, Spain