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

NCT ID: NCT03367325

Last Updated: 2018-12-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 63001 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2019-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

CDS-NVAF

Intervention Type: 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 not-benefiting group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Català de la Salut

OTHER

Sponsor Role: collaborator

Department of Health, Generalitat de Catalunya

OTHER_GOV

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 38056770 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29504981 (View on PubMed)

Other Identifiers

SLT002/16/00146

Identifier Type: -

Identifier Source: org_study_id