scholarly journals The effect of shared decision-making for stroke prevention on treatment adherence and safety outcomes in patients with atrial fibrillation: a randomized clinical trial

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
P Noseworthy ◽  
M.E Branda ◽  
M Kunneman ◽  
I.G Hargraves ◽  
A.L Sivly ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Decision Making ◽  
Usual Care ◽  
Randomized Trial ◽  
Shared Decision Making ◽  
Patient Adherence ◽  
Care Plan ◽  
Shared Decision ◽  
Clinical Safety ◽  
Safety Outcomes

Abstract Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation (AF). We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision making and clinician satisfaction, without affecting encounter length. Purpose We aimed to estimate the extent to which use of an SDM tool affected patient adherence to the decided care plan and clinical safety endpoints. Methods We conducted a multi-center, encounter-level randomized trial assessing the efficacy of UC with vs. without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice, AC) in patients with non-valvular AF considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months post-enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled [PDC] for DOAC, and as time in therapeutic range (TTR) for warfarin). We also followed for any safety outcomes (stroke [stroke or transient ischemic attack], major bleeding, or death). Results We enrolled 922 evaluable patient encounters (AC=463, UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary (78% of patients in AC filled their first prescription vs. 81% in UC) or secondary adherence to anticoagulation (see Figure, PDCDOAC was 74.1% in AC vs. 71.6% in UC; TTRwarfarin was 66.6% in AC vs. 64.4% in UC). PDCDOAC was better (65%) in AC than in UC (55%) (OR 1.49, CIs 1.00, 2.22). Safety outcomes, mostly bleeds, occurred in 13% (AC) of and 14% (UC) of participants. Conclusions This is the largest reported randomized trial in AF comparing usual care with and without an SDM tool to promote SDM. Although patients were more actively involved in SDM, we found no significant differences between arms in primary or secondary adherence to anticoagulation or clinical safety outcomes. FUNDunding Acknowledgement Type of funding sources: Other. Main funding source(s): The trial was funded by and conducted independently of the National Heart, Lung, and Blood Institute (NHLBI) of the U.S. National Institutes of Health (RO1 HL131535-01). The funding body had no influence on the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Figure 1

scholarly journals Effect of Shared Decision‐Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial

2022 ◽  
Author(s):  
Peter A. Noseworthy ◽  
Megan E. Branda ◽  
Marleen Kunneman ◽  
Ian G. Hargraves ◽  
Angela L. Sivly ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Decision Making ◽  
Randomized Trial ◽  
Shared Decision Making ◽  
Therapeutic Range ◽  
Oral Anticoagulant ◽  
Shared Decision ◽  
Direct Oral Anticoagulant ◽  
Clinical Safety ◽  
Safety Outcomes

Background Guidelines promote shared decision‐making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within‐encounter SDM tool to usual care (UC) increases patient involvement in decision‐making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter‐level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow‐up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

Use of an Atrial Fibrillation Medication Decision Aid Improves Knowledge and Process for Decision Making (Preprint)

2018 ◽  
Author(s):  
Molly Beinfeld ◽  
Suzanne Brodney ◽  
Michael Barry ◽  
Erika Poole ◽  
Adam Kunin
Keyword(s):  
Atrial Fibrillation ◽  
Decision Making ◽  
Shared Decision Making ◽  
Anticoagulant Therapy ◽  
Decision Aid ◽  
Response Rate ◽  
Intervention Group ◽  
Shared Decision ◽  
Community Based ◽  
Baseline Group

BACKGROUND A rural community-based Cardiology practice implemented shared decision making supported by an evidence-based decision aid booklet to improve the quality of anticoagulant therapy decisions in patients with atrial fibrillation. OBJECTIVE To develop a practical workflow for implementation of an anticoagulant therapy decision aid and to assess the impact on patients’ knowledge and process for anticoagulant medication decision making. METHODS The organization surveyed all patients with atrial fibrillation being seen at Copley Hospital to establish a baseline level of knowledge, certainty about the decision and process for decision making. The intervention surveys included the same knowledge, certainty, process and demographic questions as the baseline surveys, but also included questions asking for feedback on the decision aid booklet. Stroke risk scores (CHA2DS2-VASc score) were calculated by Copley staff for both groups using EMR data. RESULTS We received 46 completed surveys in the baseline group (64% response rate) and 50 surveys in the intervention group (72% response rate). The intervention group had higher knowledge score than the baseline group (3.6 out of 4 correct answers vs 3.1, p=0.036) and Decision Process Score (2.89 out of 4 vs 2.09, p=0.0023) but similar scores on the SURE scale (3.12 out of 4 vs 3.17, p=0.79). Knowledge and Process score differences were sustained even after adjusting for co-variates in stepwise linear regression analyses. Patients with high school or lower education appeared to benefit the most from shared decision making, as demonstrated by their knowledge scores. CONCLUSIONS It is feasible and practical to implement shared decision making supported by decision aids in a community-based Cardiology practice. Shared decision making can improve knowledge and process for decision making for patients with atrial fibrillation. CLINICALTRIAL None

scholarly journals Choice of Intensive Lifestyle Change and/or Metformin after Shared Decision Making for Diabetes Prevention: Results from the Prediabetes Informed Decisions and Education (PRIDE) Study

2021 ◽  
pp. 0272989X2110012
Author(s):  
Tannaz Moin ◽  
Jacqueline M. Martin ◽  
Carol M. Mangione ◽  
Jonathan Grotts ◽  
Norman Turk ◽  
...  
Keyword(s):  
Decision Making ◽  
Usual Care ◽  
Shared Decision Making ◽  
Diabetes Prevention ◽  
Lifestyle Change ◽  
Diabetes Incidence ◽  
Shared Decision ◽  
Informed Decisions ◽  
Unit Increase ◽  
Pride Study

Introduction While the Diabetes Prevention Program Study demonstrated that intensive lifestyle change and metformin both reduce type 2 diabetes incidence, there are little data on patient preferences in real-world, clinical settings. Methods The Prediabetes Informed Decisions and Education (PRIDE) study was a cluster-randomized trial of shared decision making (SDM) for diabetes prevention. In PRIDE, pharmacists engaged patients with prediabetes in SDM using a decision aid with information about both evidence-based options. We recorded which diabetes prevention option(s) participants chose after the SDM visit. We also evaluated logistic regression models examining predictors of choosing intensive lifestyle change ± metformin, compared to metformin or usual care, and predictors of choosing metformin ± intensive lifestyle change, compared to intensive lifestyle change or usual care. Results Among PRIDE participants ( n = 515), 55% chose intensive lifestyle change, 8.5% chose metformin, 15% chose both options, and 21.6% declined both options. Women (odds ratio [OR] = 1.60, P = 0.023) had higher odds than men of choosing intensive lifestyle change. Patients >60 years old (OR = 0.50, P = 0.028) had lower odds than patients <50 years old of choosing metformin. Participants with higher body mass index (BMI) had higher odds of choosing intensive lifestyle change (OR = 1.07 per BMI unit increase, P = 0.005) v. other options and choosing metformin (OR = 1.06 per BMI unit increase, P = 0.008) v. other options. Conclusions Patients with prediabetes are making choices for diabetes prevention that generally align with recommendations and expected benefits from the published literature. Our results are important for policy makers and clinicians, as well as program planners developing systemwide approaches for diabetes prevention.

Optimizing patient adherence to stroke rehabilitation: A mixed method telerehabilitation trial (Preprint)

2021 ◽  
Author(s):  
Isabelle Gaboury ◽  
Michel Tousignant ◽  
Hélène Corriveau ◽  
Matthew Menear ◽  
Guylaine Le Dorze ◽  
...  
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Stroke Rehabilitation ◽  
Patient Adherence ◽  
Interprofessional Collaboration ◽  
Interdisciplinary Collaboration ◽  
Control Group ◽  
Shared Decision ◽  
The Impact

BACKGROUND Strong evidence supports beginning stroke rehabilitation as soon as the patient’s medical status has stabilized and continuing following discharge from acute care. However, adherence to rehabilitation treatments over the rehabilitation phase has been shown to be suboptimal. OBJECTIVE Objective: The aim of this study is to assess the impact of a telerehabilitation platform on stroke patients’ adherence to a rehabilitation plan and on their level of reintegration to normal social activities, in comparison with usual care. The primary outcome is patient adherence to stroke rehabilitation (up to 12 weeks), which is hypothesized to influence reintegration to normal living. Secondary outcomes for patients include functional recovery and independence, depression, adverse events related to telerehabilitation, use of services (up to 6 months), perception of interprofessional shared decision making, and quality of services received. Interprofessional collaboration as well as quality of interprofessional shared decision making will be measured on clinicians. METHODS In this interrupted time series with a convergent qualitative component, rehabilitation teams will be trained to develop rehabilitation treatment plans that engage the patient and family, while taking advantage of a telerehabilitation platform to deliver the treatment. The intervention will entail 220 patients to receive stroke telerehabilitation with an interdisciplinary group of clinicians (telerehabilitation) versus face-to-face, standard of care (n = 110 patients). RESULTS Results: Our Research Ethics Board has approved the study in June 2020. Data collection for the control group is underway, with another year planned before we begin the intervention phase. CONCLUSIONS This study will contribute to minimize both knowledge and practice gaps, while producing robust, in-depth data on the factors related to the effectiveness of telerehabilitation in a stroke rehabilitation continuum. Findings will inform best practices guidelines regarding telecare services and the provision of telerehabilitation, including recommendations regarding effective interdisciplinary collaboration regarding stroke rehabilitation. CLINICALTRIAL ClinicalTrials.gov NCT04440215

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

2020 ◽  
Vol 180 (9) ◽  
pp. 1215 ◽  
Author(s):  
Marleen Kunneman ◽  
Megan E. Branda ◽  
Ian G. Hargraves ◽  
Angela L. Sivly ◽  
Alexander T. Lee ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Decision Making ◽  
Shared Decision Making ◽  
Stroke Prevention ◽  
Shared Decision
Sign in / Sign up

Export Citation Format

Share Document