Clinical trial NCT03367325: Clinical Decision Support Tool for Improving the Adequacy of Anticoagulant Therapy in Non-valvular Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Anticoagulants
Clinical Decision Support Systems
Keywords: non-valvular atrial fibrillation
time in therapeutic range
primary care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
name: Department of Health, Generalitat de Catalunya
First posted: 2017-12-08
Enrollment: 63001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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.

Primary outcomes:
measure: Incidence rate of Thromboembolic events
timeFrame: Two years after the beginning of the intervention
measure: Incidence rate of Hemorrhagic events
timeFrame: Two years after the beginning of the intervention
measure: Incidence rate of mortality
timeFrame: Two years after the beginning of the intervention
measure: Adequacy of anticoagulant treatment
timeFrame: one year after the beginning of the intervention
Secondary outcomes:
measure: Sociodemographic characteristics of the patients
timeFrame: at the beginning of the intervention
measure: Primary Care Center (PCC) characteristics: teaching center
timeFrame: at the beginning of the intervention
measure: Primary Care Center (PCC) characteristics: urban/rural
timeFrame: at the beginning of the intervention
measure: Primary Care Center (PCC) characteristics: socioeconomic deprivation index (MEDEA)
timeFrame: at the beginning of the intervention
measure: Primary Care Center (PCC) characteristics: Standard of Health Care Quality (SHCQ)
timeFrame: at the beginning of the intervention
measure: Primary Care Center (PCC) characteristics: Standard of Quality of Pharmaceutical Prescription (SQPP)
timeFrame: at the beginning of the intervention
measure: Characteristics of the professional: age
timeFrame: at the beginning of the intervention
measure: Characteristics of the professional: sex
timeFrame: at the beginning of the intervention
measure: Characteristics of the professional: PCC
timeFrame: at the beginning of the intervention
measure: Characteristics of the professional: type of work contract
timeFrame: at the beginning of the intervention
measure: Characteristics of the professional: Standard of Health Care Quality (SHCQ)
timeFrame: at the beginning of the intervention
measure: Characteristics of the professional: Standard of Quality of Pharmaceutical Prescription (SQPP)
timeFrame: at the beginning of the intervention
measure: Treatment by direct-acting oral antagonists
timeFrame: at the beginning of the intervention and one year after the beginning of the intervention
measure: Treatment by Vitamin K antagonists
timeFrame: at the beginning of the intervention and one year after the beginning of the intervention
measure: Treatment by heparin
timeFrame: at the beginning of the intervention and one year after the beginning of the intervention
measure: 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
timeFrame: at the beginning of the intervention and one year after the beginning of the intervention
measure: Bleeding risk HAS-BLED (Hypertension, Abnormal liver/renal function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), and Drugs/alcohol) score
timeFrame: at the beginning of the intervention and one year after the beginning of the intervention
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
Study officials:
References:
citation: Dalmau 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.