Implementation of the Canadian syncope pathway: a pilot non-randomized stepped wedge trial.

BACKGROUND: We developed the Canadian Syncope Pathway (CSP) based on the Canadian Syncope Risk Score (CSRS) to aid emergency department (ED) syncope management. This pilot implementation study assessed patient inclusion, length of transition period, as well as process measures (engagement, reach, adoption, and fidelity) to prepare for multicenter implementation. METHODS: A non-randomized stepped wedge trial at two hospitals was conducted over a 7-month period. After 2-3 months in the control condition, the hospitals crossed over in a stepwise fashion to the intervention condition. Study participants were ED and non-ED physicians, or their delegates, and patients (aged ≥ 18 years) with syncope. We aimed to analyze patient characteristics, ED management including disposition decision, and CSRS recommendations application for all eligible patients during the intervention period. Our targets were 95% inclusion rate, 70% adoption (proportion of physicians who applied the pathway), 60% reach (intervention applied to eligible patients) and 70% fidelity (appropriate recommendations application) for all eligible patients. Clinical Trials registration NCT04790058. RESULTS: 1002 eligible patients (mean age 56.6 years; 51.0% males) were included: 349 patients during the control and 653 patients during the intervention period. Physician engagement varied from 39.7% to 97.1% for presentation at meetings. Process measures for the first month and the end of the intervention were: adoption 70.7% (58/82) and 84.4% (103/122), reach 67.5% (108/160) and 55.0% (359/653), fidelity among patients with physician data form completion 86.3% (88/102) and 88.3% (294/333), versus fidelity among all eligible patients 83.8% (134/160) and 83.3% (544/653) respectively with no significant differences in fidelity at one month and the end of the intervention period. CONCLUSION: In this pilot study, we achieved all prespecified benchmarks for proceeding to the multicenter CSP implementation except reach. Our results indicate a 1-month transition period will be adequate though regular reminders will be needed during full-scale implementation.

RéSUMé: CONTEXTE: Nous avons mis au point la Canadian Syncope Pathway (CSP) basée sur le Canadian Syncope Risk Score (CSRS) pour aider les services d'urgence à gérer la syncope. Cette étude pilote de mise en œuvre a évalué l'inclusion des patients, la durée de la période de transition, ainsi que les mesures de processus (engagement, portée, adoption et fidélité) pour se préparer à la mise en œuvre multicentrique MéTHODES: Un essai par étapes non randomisé dans deux hôpitaux a été mené sur une période de 7 mois. Après 2 à 3 mois dans l'état de contrôle, les hôpitaux sont passés progressivement à l'état d'intervention. Les participants à l'étude étaient des médecins du service de l'urgence et non du service de l'urgence, ou leurs délégués, et des patients (âgés de 18 ans) atteints de syncope. Nous avons cherché à analyser les caractéristiques des patients, la prise en charge des urgences, y compris la décision de disposition, et l'application des recommandations du CSRS pour tous les patients admissibles pendant la période d'intervention. Nos cibles étaient le taux d'inclusion de 95 %, l'adoption de 70 % (proportion de médecins qui ont appliqué la voie), la portée de 60 % (intervention appliquée aux patients admissibles) et la fidélité de 70 % (application des recommandations appropriées) pour tous les patients admissibles. Enregistrement des essais cliniques NCT04790058. RéSULTATS: 1002 patients éligibles (âge moyen 56,6 ans; 51,0% d'hommes) ont été inclus : 349 patients pendant le contrôle et 653 patients pendant la période d'intervention. La participation des médecins variait de 39,7 % à 97,1 % pour la présentation aux réunions. Les mesures du processus pour le premier mois et la fin de l'intervention étaient les suivantes : adoption 70,7 % (58/82) et 84,4 % (103/122), atteinte de 67,5 % (108/160) et 55,0 % (359/653), fidélité chez les patients ayant rempli le formulaire de données médicales 86,3 % (88/102) et 88,3 % (294/333), versus fidélité chez tous les patients admissibles 83,8 % (134/160) et 83,3 % (544/653) respectivement, sans différence significative de fidélité à un mois et à la fin de la période d'intervention. CONCLUSION: Dans cette étude pilote, nous avons atteint tous les points de repère prédéterminés pour procéder à la mise en œuvre du PSC multicentrique, sauf la portée. Nos résultats indiquent qu'une période de transition d'un mois sera adéquate, bien que des rappels réguliers seront nécessaires pendant la mise en œuvre à grande échelle.

Personalised risk prediction following emergency department assessment for syncope.

BACKGROUND: Published risk tools do not provide possible management options for syncope in the emergency department (ED). Using the 30-day observed risk estimates based on the Canadian Syncope Risk Score (CSRS), we developed personalised risk prediction to guide management decisions. METHODS: We pooled previously reported data from two large cohort studies, the CSRS derivation and validation cohorts, that prospectively enrolled adults (≥16 years) with syncope at 11 Canadian EDs between 2010 and 2018. Using this larger cohort, we calculated the CSRS calibration and discrimination, and determined with greater precision than in previous studies the 30-day risk of adjudicated serious outcomes not identified during the index ED evaluation depending on the CSRS and the risk category. Based on these findings, we developed an on-line calculator and pictorial decision aids. RESULTS: 8233 patients were included of whom 295 (3.6%, 95% CI 3.2% to 4.0%) experienced 30-day serious outcomes. The calibration slope was 1.0, and the area under the curve was 0.88 (95% CI 0.87 to 0.91). The observed risk increased from 0.3% (95% CI 0.2% to 0.5%) in the very-low-risk group (CSRS -3 to -2) to 42.7% (95% CI 35.0% to 50.7%), in the very-high-risk (CSRS≥+6) group (Cochrane-Armitage trend test p<0.001). Among the very-low and low-risk patients (score -3 to 0), ≤1.0% had any serious outcome, there was one death due to sepsis and none suffered a ventricular arrhythmia. Among the medium-risk patients (score +1 to+3), 7.8% had serious outcomes, with <1% death, and a serious outcome was present in >20% of high/very-high-risk patients (score +4 to+11) including 4%-6% deaths. The online calculator and the pictorial aids can be found at: https://teamvenk.com/csrs CONCLUSIONS: 30-day observed risk estimates from a large cohort of patients can be obtained for management decision-making. Our work suggests very-low-risk and low-risk patients may be discharged, discussion with patients regarding investigations and disposition are needed for medium-risk patients, and high-risk patients should be hospitalised. The online calculator, accompanied by pictorial decision aids for the CSRS, may assist in discussion with patients.