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; Gorr, Haeshik; Wambua, Mike; Keune, Shelly; Zeballos-Palacios, Claudia; Hargraves, Ian; Shah, Nilay D.; Montori, Víctor M.

doi:10.1186/s13063-017-2178-y

Cited by 27 publications

(28 citation statements)

References 55 publications

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“…Conclusions about the extent to which Anticoagulation Choice can support this goal await the results of an ongoing randomized trial of Anticoagulation Choice versus usual care of at-risk patients with AF. 59…”

Section: Resultsmentioning

confidence: 99%

“…In the development of Anticoagulation Choice we observed and field tested prototypes in a variety of contexts in our institution that serve patients with AF, including primary care, emergency medicine, cardiology, anticoagulation clinics, and thrombophilia subspecialty clinics. In addition, recognizing that care varies across organizations, we also sought input during development from institutions that would be our eventual partners in the randomized trial evaluating the tool 59 dan urban safety net hospital and a metropolitan health care systemdto ensure that it served their needs, patients, and operating context. Context also informed our tolerance for the imprecisions and inaccuracies of the data available.…”

Section: Design For Contextmentioning

confidence: 99%

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Developing a Conversation Aid to Support Shared Decision Making: Reflections on Designing Anticoagulation Choice

Noseworthy

Branda

Kunneman

et al. 2019

Mayo Clinic Proceedings

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Patient-centered care requires that treatments respond to the problematic situation of each patient in a manner that makes intellectual, emotional, and practical sense, an achievement that requires shared decision making (SDM). To implement SDM in practice, toolsdsometimes called conversation aids or decision aidsdare prepared by collating, curating, and presenting high-quality, comprehensive, and up-to-date evidence. Yet, the literature offers limited guidance for how to make evidence support SDM. Herein, we describe our approach and the challenges encountered during the development of Anticoagulation Choice, a conversation aid to help patients with atrial fibrillation and their clinicians jointly consider the risk of thromboembolic stroke and decide whether and how to respond to this risk with anticoagulation.

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Section: Resultsmentioning

confidence: 99%

Section: Design For Contextmentioning

confidence: 99%

Developing a Conversation Aid to Support Shared Decision Making: Reflections on Designing Anticoagulation Choice

Noseworthy

Branda

Kunneman

et al. 2019

Mayo Clinic Proceedings

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“…The clinical trial recruitment goal was 1000 patient encounters (500 encounters per arm) based on previously reported sample size estimations. 17 As conducted, the clinical trial produced estimates of between-arm differences with a margin of error (one-half of the 95% CI) of 1.9 (out of 100) for the Decisional Conflict Scale, 1.4 (out of 100) for the OPTION12 scale, and 1.4 minutes for the encounter duration. For binary outcomes, the margin of error ranged from 3% to 9%, with patient knowledge estimates having a margin of error of 14%.…”

Section: Methodsmentioning

confidence: 99%

“…To address these limitations and support at-risk patients with AF and their clinicians in making decisions about anticoagulant treatment, we developed the Anticoagulation Choice Shared Decision Making tool. 17 , 18 The aim of the current study was to assess the extent to which the use of the Anticoagulation Choice Shared Decision Making tool affects the quality of SDM and anticoagulant treatment decisions in patients with AF who are at risk of experiencing stroke.…”

Section: Introductionmentioning

confidence: 99%

Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation

et al. 2020

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; for the Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators IMPORTANCE Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear. OBJECTIVE To assess the extent to which the use of an SDM tool affects the quality of SDM and anticoagulant treatment decisions in at-risk patients with AF. DESIGN, SETTING, AND PARTICIPANTS This encounter-randomized trial recruited patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019. Encounters were randomized to either the standard care arm or care that included the use of an SDM tool (intervention arm). Data were analyzed from August 1 to November 30, 2019. INTERVENTIONS Standard care or care using the Anticoagulation Choice Shared Decision Making tool (which presents individualized risk estimates and compares anticoagulant treatment options across issues of importance to patients) during the clinical encounter. MAIN OUTCOMES AND MEASURES Quality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process. RESULTS The clinical trial enrolled 922 patients (559 men [60.6%]; mean [SD] age, 71 [11] years) and 244 clinicians. A total of 463 patients were randomized to the intervention arm and 459 patients to the standard care arm. Participants in both arms reported high communication quality, high knowledge, and low decisional conflict, demonstrated low accuracy in their risk perception, and would similarly recommend the approach used in their encounter. Clinicians were significantly more satisfied after intervention encounters (400 of 453 encounters [88.3%] vs 277 of 448 encounters [61.8%]; adjusted relative risk, 1.49; 95% CI, 1.42-1.53). A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication. Patient involvement in decision-making (as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale) scores were significantly higher in the intervention arm (mean [SD] score, 33.0 [10.8] points vs 29.1 [13.1] points, respectively; adjusted mean difference, 4.2 points; 95% CI, 2.8-5.6 points). No significant between-arm difference was found in encounter duration (mean [SD] duration, 32 [16] minutes in the intervention arm vs 31 [17] minutes in the standard care arm; adjusted mean between-arm difference, 1.1; 95% CI, −0.3 to 2.5 minutes). CONCLUSION AND RELEVANCE The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions...

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“…Twelve decision aids met more than 50% of the IPDAS items (Figure 2). The top-rated tools were PtDA, [51][52][53] Anticoagulation Choice, [45][46][47][48] Don't Wait to Anticoagulate, 38 and PDA, 55 which met .70% of all IPDAS items. PtDA was the only tool that assessed for readability.…”

Section: Sdm Tool Quality Assessmentmentioning

confidence: 99%

Shared Decision Making Tools for People Facing Stroke Prevention Strategies in Atrial Fibrillation: A Systematic Review and Environmental Scan

et al. 2021

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Objective Shared decision making (SDM) tools can help implement guideline recommendations for patients with atrial fibrillation (AF) considering stroke prevention strategies. We sought to characterize all available SDM tools for this purpose and examine their quality and clinical impact. Methods We searched through multiple bibliographic databases, social media, and an SDM tool repository from inception to May 2020 and contacted authors of identified SDM tools. Eligible tools had to offer information about warfarin and ≥1 direct oral anticoagulant. We extracted tool characteristics, assessed their adherence to the International Patient Decision Aids Standards, and obtained information about their efficacy in promoting SDM. Results We found 14 SDM tools. Most tools provided up-to-date information about the options, but very few included practical considerations (e.g., out-of-pocket cost). Five of these SDM tools, all used by patients prior to the encounter, were tested in trials at high risk of bias and were found to produce small improvements in patient knowledge and reductions in decisional conflict. Conclusion Several SDM tools for stroke prevention in AF are available, but whether they promote high-quality SDM is yet to be known. The implementation of guidelines for SDM in this context requires user-centered development and evaluation of SDM tools that can effectively promote high-quality SDM and improve stroke prevention in patients with AF.

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

Cited by 27 publications

References 55 publications

Developing a Conversation Aid to Support Shared Decision Making: Reflections on Designing Anticoagulation Choice

Developing a Conversation Aid to Support Shared Decision Making: Reflections on Designing Anticoagulation Choice

Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation

Shared Decision Making Tools for People Facing Stroke Prevention Strategies in Atrial Fibrillation: A Systematic Review and Environmental Scan

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