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Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial

BACKGROUND: Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient’s goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decisi...

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Autores principales: Kunneman, Marleen, Branda, Megan E., Noseworthy, Peter A., Linzer, Mark, Burnett, Bruce, Dick, Sara, Spencer-Bonilla, Gabriela, Fernandez, Cara A., Gorr, Haeshik, Wambua, Mike, Keune, Shelly, Zeballos-Palacios, Claudia, Hargraves, Ian, Shah, Nilay D., Montori, Victor M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5622521/
https://www.ncbi.nlm.nih.gov/pubmed/28962662
http://dx.doi.org/10.1186/s13063-017-2178-y
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author Kunneman, Marleen
Branda, Megan E.
Noseworthy, Peter A.
Linzer, Mark
Burnett, Bruce
Dick, Sara
Spencer-Bonilla, Gabriela
Fernandez, Cara A.
Gorr, Haeshik
Wambua, Mike
Keune, Shelly
Zeballos-Palacios, Claudia
Hargraves, Ian
Shah, Nilay D.
Montori, Victor M.
author_facet Kunneman, Marleen
Branda, Megan E.
Noseworthy, Peter A.
Linzer, Mark
Burnett, Bruce
Dick, Sara
Spencer-Bonilla, Gabriela
Fernandez, Cara A.
Gorr, Haeshik
Wambua, Mike
Keune, Shelly
Zeballos-Palacios, Claudia
Hargraves, Ian
Shah, Nilay D.
Montori, Victor M.
author_sort Kunneman, Marleen
collection PubMed
description BACKGROUND: Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient’s goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the Anticoagulation Choice conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes. METHODS: This study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the Anticoagulation Choice conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA(2)DS(2)-VASc score ≥ 1 in men, or ≥ 2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients’ medical and pharmacy records. Strokes and bleeding events will be drawn from patient records. DISCUSSION: This study will provide a valid and precise measure of the effect of the Anticoagulation Choice conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02905032. Registered on 9 September 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2178-y) contains supplementary material, which is available to authorized users.
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spelling pubmed-56225212017-10-11 Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial Kunneman, Marleen Branda, Megan E. Noseworthy, Peter A. Linzer, Mark Burnett, Bruce Dick, Sara Spencer-Bonilla, Gabriela Fernandez, Cara A. Gorr, Haeshik Wambua, Mike Keune, Shelly Zeballos-Palacios, Claudia Hargraves, Ian Shah, Nilay D. Montori, Victor M. Trials Study Protocol BACKGROUND: Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient’s goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the Anticoagulation Choice conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes. METHODS: This study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the Anticoagulation Choice conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA(2)DS(2)-VASc score ≥ 1 in men, or ≥ 2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients’ medical and pharmacy records. Strokes and bleeding events will be drawn from patient records. DISCUSSION: This study will provide a valid and precise measure of the effect of the Anticoagulation Choice conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02905032. Registered on 9 September 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2178-y) contains supplementary material, which is available to authorized users. BioMed Central 2017-09-29 /pmc/articles/PMC5622521/ /pubmed/28962662 http://dx.doi.org/10.1186/s13063-017-2178-y Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Kunneman, Marleen
Branda, Megan E.
Noseworthy, Peter A.
Linzer, Mark
Burnett, Bruce
Dick, Sara
Spencer-Bonilla, Gabriela
Fernandez, Cara A.
Gorr, Haeshik
Wambua, Mike
Keune, Shelly
Zeballos-Palacios, Claudia
Hargraves, Ian
Shah, Nilay D.
Montori, Victor M.
Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial
title Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial
title_full Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial
title_fullStr Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial
title_full_unstemmed Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial
title_short Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial
title_sort shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5622521/
https://www.ncbi.nlm.nih.gov/pubmed/28962662
http://dx.doi.org/10.1186/s13063-017-2178-y
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