Presentation Details
| An Implementation Dilemma: Rejection of Thromboprophylaxis Recommendations in the Children’s Likelihood of Thrombosis (CLOT) Trial Shannon C.Walker, Benjamin French, Ryan P.Moore, Henry J.Domenico, C.Buddy Creech, Amanda S.Mixon, Daniel W.Byrne, Allison P.Wheeler. Vanderbilt University Medical Center, Nashville, TN, USA |
Abstract
Background: The Children’s Likelihood of Thrombosis (CLOT) trial was performed at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV) from November 2, 2020 through January 31, 2022 and included 17,427 hospital admissions in the primary analysis (Trials 2022 and JAMA Network Open 2023). We identified 135 hospital-acquired venous thromboembolic (HA-VTE) events during the study period; 58 in the control group and 77 in the intervention group (risk difference: 2.2 per 1000 patients; 95%CI, -0.4 to 4.8 per 1000 patients, p=0.10). During the study, hematology recommendations for thromboprophylaxis in elevated risk patients were followed in only 25.8% of admissions. Objectives: We sought to identify the key drivers of provider rejection thromboprophylaxis recommendations so that targeted implementation efforts can be developed to improve acceptance rates in future studies. Methods: In the CLOT trial, all eligible pediatric patients (<22 years old) admitted under inpatient status to MCJCHV during the study period underwent automated randomization into the intervention or control group. HA-VTE risk scores were calculated on admission and recalculated daily. HA-VTE risk scores in the intervention group were visible to the hematology study team in real time and patients at elevated risk (>2.5%) underwent clinical review; based on the clinical scenario, the study team determined whether to recommend thromboprophylaxis. Recommendations were discussed in person or via telephone with the providers on the patient’s primary healthcare team and were documented in the patient’s electronic medical record. All study related data, including reasons the study team did not recommend prophylaxis in patients with elevated risk and reasons why healthcare providers did not follow recommendations for thromboprophylaxis, were recorded in the study database. Results: Within the intervention group, 41.4% of patients at elevated risk for HA-VTE were deemed clinically ineligible for thromboprophylaxis due to potential risks, including prematurity <34 weeks, active hemorrhage, upcoming surgical procedure, or thrombocytopenia. When recommendations to initiate thromboprophylaxis were made by the study team, the primary team followed these recommendations only 25.8% of the time. Clinical teams’ acceptance of the recommendations varied from 41% (pediatric intensive care unit) to 0% (pediatric bone marrow transplant) [Table 1]. Reasons for rejecting study team recommendations most commonly included expectation of upcoming discharge, concern for bleeding, and lack of perceived HA-VTE risk. Conclusions: While HA-VTE model performance remained strong (control group c-statistic = 0.799 (95% CI 0.725 to 0.856) in this prospective, randomized study, there was significant variability in the acceptance of the study team’s recommendations for thromboprophylaxis. Clinical teams ranged from 41% overall acceptance to 0% acceptance. Future work will be needed to identify and overcome these implementation barriers.
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No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.