Clinical Decision Support for Stroke Prevention in Atrial Fibrillation

NCT02635685 | Unknown

• 1 other identifier: 2015/398-32
• Study Type: interventional
• Target: 442,105
• Locations: 1 country
• Sites: 1

Brief Summary

A cluster randomised study in the primary care setting to evaluate a electronic clinical decision tool for stroke prophylaxis in patients with atrial fibrillation.

Conditions

Cardiovascular Disease; Atrial Fibrillation; Stroke

Keywords

Atrial fibrillation; Stroke; Clinical Decision Support; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• Adherence to guidelines defined as the percentage of patients with atrial fibrillation and CHA2DS2VASc ≥ 1, (not only female gender) that are prescribed anticoagulant therapy (ATC-code B01A).

  The data will be recorded through the electronic journal where the diagnosis for atrial fibrillation/flutter, the conditions constituting the CHA2DS2VASc algorithm as well as the medication list is logged.

  12 months after study commencement

Secondary Outcomes (4)

• Reduction av thromboembolism. This will be analyzed through the electronic medical journal by identifying the patients with new (since commencement of the study) diagnosis of thromboembolism. ICD-10 codes I63-64, G45, I75 will be analyzed.

  12 months after study commencement and 3 and 6 years after study finish.

• Analysis of physician acceptance of a clinical decision tool in the primary care setting with questionnaires to randomly assigned general physicians.

  Before study commencement and after 12 months

• Analysis of reasons to deviate from guidelines. As part of the clinical decision tool there are prespecified reasons to choose from if no therapy is prescribed. The main reasons will be summarized.

  12 months after study commencement

• Cost-effectiveness of using clinical decision support tool for stroke prevention in the primary care setting.

  12 months follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention with Clinical Decision Support tool installed on units.

Other: Clinical Decision Support tool

Control group

NO INTERVENTION

Control group without intervention with Clinical Decision Support tool installed on units.

Interventions

Clinical Decision Support tool OTHER

Automatized support tool for identification of patients with a diagnosis of atrial fibrillation without appropriate anticoagulant therapy for stroke prevention.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care centers in the county of Östergötland, Sweden.

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Linkoeping University: collaborator

Study Sites (1)

The County of Östergötland

Linköping, Sweden

Location

Related Publications (11)

• Friberg L, Bergfeldt L. Atrial fibrillation prevalence revisited. J Intern Med. 2013 Nov;274(5):461-8. doi: 10.1111/joim.12114. Epub 2013 Aug 7.

  PMID: 23879838 BACKGROUND

• Riks-stroke. Annual report 2013 (in Swedish). http://www.riksstroke.org/wp-content/uploads/2014/07/Strokerapport_AKUTTIA3man_LR.pdf. Accessed November 2014.

  BACKGROUND

• Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.

  PMID: 17577005 BACKGROUND

• Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association. Europace. 2012 Oct;14(10):1385-413. doi: 10.1093/europace/eus305. Epub 2012 Aug 24. No abstract available.

  PMID: 22923145 BACKGROUND

• Bjorck S, Palaszewski B, Friberg L, Bergfeldt L. Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population-based study. Stroke. 2013 Nov;44(11):3103-8. doi: 10.1161/STROKEAHA.113.002329. Epub 2013 Aug 27.

  PMID: 23982711 BACKGROUND

• Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Turpie AG, van Eickels M, Misselwitz F, Rushton-Smith S, Kayani G, Wilkinson P, Verheugt FW; GARFIELD Registry Investigators. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One. 2013 May 21;8(5):e63479. doi: 10.1371/journal.pone.0063479. Print 2013.

  PMID: 23704912 BACKGROUND

• Öppna jämförelser: hälso- och sjukvård 2014, del 2 (in Swedish). http://webbutik.skl.se/sv/artiklar/oppna-jamforelser-halso-och-sjukvard-2014-del-1.html. Accessed December 4, 2014.

  BACKGROUND

• Lobach D, Sanders GD, Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian L, Coeytaux R, Samsa G, Hasselblad V, Williams JW, Wing L, Musty M, Kendrick AS. Enabling health care decisionmaking through clinical decision support and knowledge management. Evid Rep Technol Assess (Full Rep). 2012 Apr;(203):1-784.

  PMID: 23126650 BACKGROUND

• Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian L, Coeytaux RR, Samsa G, Hasselblad V, Williams JW, Musty MD, Wing L, Kendrick AS, Sanders GD, Lobach D. Effect of clinical decision-support systems: a systematic review. Ann Intern Med. 2012 Jul 3;157(1):29-43. doi: 10.7326/0003-4819-157-1-201207030-00450.

  PMID: 22751758 BACKGROUND

• Persson Lindell O, Henriksson M, Karlsson LO, Nilsson S, Charitakis E, Janzon M. Cost-effectiveness of a clinical decision support system for atrial fibrillation: an RCT-based modelling study. Eur Heart J Digit Health. 2025 Aug 1;6(5):997-1005. doi: 10.1093/ehjdh/ztaf087. eCollection 2025 Sep.

  PMID: 40984984 DERIVED

• Karlsson LO, Nilsson S, Bang M, Nilsson L, Charitakis E, Janzon M. A clinical decision support tool for improving adherence to guidelines on anticoagulant therapy in patients with atrial fibrillation at risk of stroke: A cluster-randomized trial in a Swedish primary care setting (the CDS-AF study). PLoS Med. 2018 Mar 13;15(3):e1002528. doi: 10.1371/journal.pmed.1002528. eCollection 2018 Mar.

  PMID: 29534063 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Lars O Karlsson, MD, PhD

  Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 21, 2015
• Study Start: January 11, 2016
• Primary Completion: January 11, 2017
• Study Completion: January 11, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

SE (1)