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

NCT03367325 | Unknown

• 1 other identifier: SLT002/16/00146
• Study Type: interventional
• Target: 63,001
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation; Anticoagulants; Clinical Decision Support Systems

Keywords

non-valvular atrial fibrillation; time in therapeutic range; primary care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (17)

• Sociodemographic characteristics of the patients

  at the beginning of the intervention

• Primary Care Center (PCC) characteristics: teaching center

  at the beginning of the intervention

• Primary Care Center (PCC) characteristics: urban/rural

  at the beginning of the intervention

• Primary Care Center (PCC) characteristics: socioeconomic deprivation index (MEDEA)

  at the beginning of the intervention

• Primary Care Center (PCC) characteristics: Standard of Health Care Quality (SHCQ)

  at the beginning of the intervention

Study Arms (2)

CDS-NVAF benefiting group

EXPERIMENTAL

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

CDS-NVAF not-benefiting group

NO INTERVENTION

Interventions

CDS-NVAF DEVICE

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.

CDS-NVAF benefiting group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Institut Català de la Salut: collaborator
• Department of Health, Generalitat de Catalunya: collaborator

Study Sites (1)

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

Barcelona, 08007, Spain

Location

Related Publications (2)

• Dalmau Llorca MR, Aguilar Martin C, Carrasco-Querol N, Hernandez Rojas Z, Rodriguez Cumplido D, Castro Blanco E, Queiroga Goncalves A, Fernandez-Saez J, Perez-Villacastin J. Clinical value of a tool for managing oral anticoagulation in nonvalvular atrial fibrillation in primary health care. Randomized clinical trial. Rev Esp Cardiol (Engl Ed). 2024 Jun;77(6):471-480. doi: 10.1016/j.rec.2023.11.009. Epub 2023 Dec 4. English, Spanish.

  PMID: 38056770 DERIVED

• 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.

  PMID: 29504981 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 8, 2017
• Study Start: December 15, 2017
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

ES (1)