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

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).

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Anticoagulants; Clinical Decision Support Systems
• Intervention / Treatment: Device: CDS-NVAF

• Study Type: Interventional
• Enrollment (Anticipated): 63001
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08007
    • Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence rate of Hemorrhagic events	Hemorrhagic events: intracranial hemorrhage and gastrointestinal hemorrhage	Two years after the beginning of the intervention
Incidence rate of mortality	All-cause mortality	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	one year after the beginning of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic characteristics of the patients	age, sex, primary care area assigned, physician assigned	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	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	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	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	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	at the beginning of the intervention
Characteristics of the professional: age	This variable encompasses the age of the professional	at the beginning of the intervention
Characteristics of the professional: sex	This variable encompasses the sex of the professional	at the beginning of the intervention
Characteristics of the professional: PCC	This variable identifies the PCC of the professional	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	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	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	at the beginning of the intervention
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
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
Treatment by heparin	presence / absence of heparin treatment	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).	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	at the beginning of the intervention and one year after the beginning of the intervention

Collaborators and Investigators

• Sponsor: Jordi Gol i Gurina Foundation
• Collaborators: Institut Català de la Salut; Department of Health, Generalitat de Catalunya

Publications and helpful links

General Publications

• 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. Erratum In: Medicine (Baltimore). 2018 Feb;97(6):e9915.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2017
• Primary Completion (ANTICIPATED): December 15, 2019
• Study Completion (ANTICIPATED): December 15, 2019

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (ACTUAL): December 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: primary care; non-valvular atrial fibrillation; time in therapeutic range
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SLT002/16/00146

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No