TY - JOUR
T1 - Shared Decision Making for Syncope in the Emergency Department
T2 - A Randomized Controlled Feasibility Trial
AU - Probst, Marc A.
AU - Lin, Michelle P.
AU - Sze, Jeremy J.
AU - Hess, Erik P.
AU - Breslin, Maggie
AU - Frosch, Dominick L.
AU - Sun, Benjamin C.
AU - Langan, Marie Noelle
AU - Thiruganasambandamoorthy, Venkatesh
AU - Richardson, Lynne D.
N1 - Funding Information:
We performed a single‐center, parallel randomized controlled trial of syncope patients. Patients in the intervention arm were randomized to SDM facilitated by a paper‐based, personalized, syncope patient decision aid (SynDA), while those in the control group received usual care. Given the nature of the intervention (decision aid to facilitate SDM), patients and providers were not able to be blinded. However, outcome assessors were blinded to study arm assignment. Full‐time, paid research coordinators and a project manager were trained on all aspects of the research protocol, including screening, obtaining consent, randomization, and follow‐up prior to participating in study activities. This study was approved by the institutional review board at our medical center and registered at ClinicalTrials.gov (NCT02971163). This research was funded by a Career Development Grant from the National Institutes of Health, which had no role in the conduct or reporting of the study. As much as feasible, we adhered to the CONSORT criteria for randomized controlled feasibility trials. Post hoc, we evaluated where on the pragmatic‐explanatory continuum our trial lay using the PRECIS‐2 guidelines. 24 25
Publisher Copyright:
© 2020 by the Society for Academic Emergency Medicine
PY - 2020/9/1
Y1 - 2020/9/1
N2 - Objectives: Significant practice variation is seen in the management of syncope in the emergency department (ED). We sought to evaluate the feasibility of performing a randomized controlled trial of a shared decision making (SDM) tool for low-to-intermediate–risk syncope patients presenting to the ED. Methods: We performed a randomized controlled trial of adults (≥30 years) with unexplained syncope who presented to an academic ED in the United States. Patients with a serious diagnosis identified in the ED were excluded. Patients were randomized, 1:1, to receive either usual care or a personalized syncope decision aid (SynDA) meant to facilitate SDM. Our primary outcome was feasibility, i.e., ability to enroll 50 patients in 24 months. Secondary outcomes included patient knowledge, involvement (measured with OPTION-5), rating of care, and clinical outcomes at 30 days post-ED visit. Results: After screening 351 patients, we enrolled 50 participants with unexplained syncope from January 2017 to January 2019. The most common reason for exclusion was lack of clinical equipoise to justify SDM (n = 124). Patients in the SynDA arm tended to have greater patient involvement, as shown by higher OPTION-5 scores: 52/100 versus 27/100 (between-group difference = −25.4, 95% confidence interval = −13.5 to −37.3). Both groups had similar levels of clinical knowledge, ratings of care, and serious clinical outcomes at 30 days. Conclusions: Among ED patients with unexplained syncope, a randomized controlled trial of a shared decision-making tool is feasible. Although this study was not powered to detect differences in clinical outcomes, it demonstrates feasibility, while providing key lessons and effect sizes that could inform the design of future SDM trials.
AB - Objectives: Significant practice variation is seen in the management of syncope in the emergency department (ED). We sought to evaluate the feasibility of performing a randomized controlled trial of a shared decision making (SDM) tool for low-to-intermediate–risk syncope patients presenting to the ED. Methods: We performed a randomized controlled trial of adults (≥30 years) with unexplained syncope who presented to an academic ED in the United States. Patients with a serious diagnosis identified in the ED were excluded. Patients were randomized, 1:1, to receive either usual care or a personalized syncope decision aid (SynDA) meant to facilitate SDM. Our primary outcome was feasibility, i.e., ability to enroll 50 patients in 24 months. Secondary outcomes included patient knowledge, involvement (measured with OPTION-5), rating of care, and clinical outcomes at 30 days post-ED visit. Results: After screening 351 patients, we enrolled 50 participants with unexplained syncope from January 2017 to January 2019. The most common reason for exclusion was lack of clinical equipoise to justify SDM (n = 124). Patients in the SynDA arm tended to have greater patient involvement, as shown by higher OPTION-5 scores: 52/100 versus 27/100 (between-group difference = −25.4, 95% confidence interval = −13.5 to −37.3). Both groups had similar levels of clinical knowledge, ratings of care, and serious clinical outcomes at 30 days. Conclusions: Among ED patients with unexplained syncope, a randomized controlled trial of a shared decision-making tool is feasible. Although this study was not powered to detect differences in clinical outcomes, it demonstrates feasibility, while providing key lessons and effect sizes that could inform the design of future SDM trials.
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U2 - 10.1111/acem.13955
DO - 10.1111/acem.13955
M3 - Article
C2 - 32147870
AN - SCOPUS:85082755548
SN - 1069-6563
VL - 27
SP - 853
EP - 865
JO - Academic Emergency Medicine
JF - Academic Emergency Medicine
IS - 9
ER -