Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 12, 2024
Date Accepted: Mar 27, 2025
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Ochsner Health System Protocol for Quality Improvement of Venous Thromboembolism Prophylaxis in Neurological Surgery
ABSTRACT
Background:
Venous thromboembolism (VTE) is a common post-operative complication. The peri-operative incidence of VTE in neurosurgery patients on VTE chemoprophylaxis is consistently between 1.7 and 3.5%, excluding trauma patients. While the majority of VTE’s are asymptomatic and clinically insignificant, symptomatic VTE’s may result in serious adverse events or death. Currently, there are limited neurosurgery society guidelines making VTE prophylaxis recommendations for cranial or spine neurosurgery patients. While multiple other societies have published guidelines on VTE prophylaxis in neurosurgical patients, they are largely inconsistent in their recommendations on the timing and choice of agent for chemoprophylaxis. This has resulted in a wide variation of clinical practice according to neurosurgeon preference.
Objective:
The objective of this project is to assess whether implementing a single protocol of VTE guidelines at a large hospital system department of neurosurgery would decrease the rate of VTE incidence by 50% within a 12-month period.
Methods:
This project utilizes a department-wide protocol of chemical prophylaxis for admitted patients after neurological surgery. The primary outcome is the VTE incidence over 12 months following protocol implementation. Secondary outcomes include incidence of pulmonary embolism (PE), length of hospital stay, and unexpected treatment of patients, such as therapeutic anticoagulation, thrombolysis, or emergency surgical or catheter-directed embolectomy. Balancing measures and process measures are also considered. Interim analyses with department reports will be performed every 3 months, but every VTE event will trigger an analysis of the variables described in this protocol. Analyses will consider barriers to change and adequacy of the protocol to guide protocol modifications and continuous implementation of improvements.
Results:
Results from this protocol will be reported upon study completion.
Conclusions:
This project did not meet the threshold of a clinical trial that requires Institutional Review Board (IRB) oversight per our institution IRB guidelines. Patient privacy is protected at all times, and all staff involved in this protocol adhere to the Health Insurance Portability and Accountability Act. We provide a comprehensive review of the literature and establish a gap in consistent published guidelines for VTE prophylaxis in neurosurgery patients. Results from this quality improvement project will provide evidence for the effectiveness of a unified protocol of VTE prophylaxis in this patient group. Furthermore, outcomes from this study may be utilized as the basis for guideline recommendations and will benefit not only our department but may be utilized for quality improvement (QI) of patient care at other hospitals.
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