Educating Nurses About Venous Thromboembolism Prevention
Phase: NA
Conditions: Venous Thromboembolism, Venous Thrombosis
Sponsor: Johns Hopkins University

Nurse Education Study Protocol 
 
 
Title:  Educating Nurses About Venous Thromboembolism (VTE) Prevention 
  
Registration:   ClinicalTrial.gov NCT02301793 
 
Version: 1   November 16, 2015 
 
Funding: Patient Centered Outcomes Institute (PCORI) 
                The funders will have no role in the conduct of this study 
 
Contact Information 
Elliott R. Haut, MD, PhD, FACS 
Associate Professor of Surgery, Anesthesiology / Critical Care Medicine (ACCM), 
Emergency Medicine, & Health Policy and Management 
Division of Acute Care Surgery, Department of Surgery 
The Johns Hopkins University School of Medicine 
Sheikh Zayed 6107C, 1800 Orleans St. 
Baltimore, MD 21287 
410 502 3122 (phone) 
410 502 3569 (fax) 
ehaut1@jhmi.edu 
 
 
 
 
 
 
 
 
 
 

1. Introduction 
Public Health Impact of Venous Thromboembolism 
Venous thromboembolism (VTE), comprised of deep vein thrombosis (DVT) and/or 
pulmonary embolism (PE), affects 350,000-600,000 individuals in the United States 
annually. More than 100,000 people die each year in the United States as a result of 
PE.1 Numerous studies have shown that VTE prophylaxis is vastly underutilized in 
hospitals3, 4 and the Agency for Healthcare Research and Quality (AHRQ) has listed 
strategies to improve VTE prevention on its top ten list for patient safety practices.5-8 
Consequently, numerous interventions have been implemented to improve prescription 
of VTE prophylaxis8-11 with the implicit assumption that medications prescribed for 
hospitalized patients will always be administered. 
Deficits in Knowledge about Venous Thromboembolism 
In an attempt to improve venous thromboembolism (VTE) prophylaxis adherence we 
carried out qualitative studies to obtain patients' viewpoints on how nurses should be 
educated about VTE prevention and to assess nurses' beliefs and perceptions about 
pharmacologic VTE prophylaxis. We observed deficiencies in nurses' knowledge and 
misconceptions about VTE prophylaxis that likely lowers adherence to administration of 
prescribed VTE prophylaxis doses.  
Rationale for Education Trial 
As a part of our original Patient-Centered Outcomes Research Institute (PCORI) 
proposal, we planned to educate nurses to address the observed deficiencies and 
misconceptions and improve their ability to communicate effectively with patients. 
Historically, nurse education has been done via a linear, PowerPoint-based platform 
with voice-over but with no interactive component (Static). A newer platform for nurse 
education became available for use and includes scenario-based teaching, ongoing 
assessment, and immediate remediation. Most importantly, it is a highly interactive 
product (Dynamic). 
Study Objectives and Hypotheses 
The Objective of this study is to improve knowledge about the benefits and importance 
of VTE prophylaxis and harms associated with VTE with the goal of decreasing non-
administration of prescribed VTE prophylaxis. 
 
Primary Hypothesis: Nurse participants who receive either of these interventions will 
improve administration of prescribed VTE prophylaxis evidenced by a decrease in 
frequency of non-administered doses of VTE prophylaxis, compared with their 
frequency at baseline. 
 
Secondary Hypothesis: Nurse participants who receive the Dynamic education format 
will have a larger decrease in frequency of missed doses of VTE prophylaxis compared 
with those who participate in the Static education format. 

2. Study Design 
A. Study Design 
a. Cluster randomized trial  
B. Study setting: Johns Hopkins Hospital, Baltimore MD 
C. Eligibility Criteria 
a. All nurses permanently assigned to one of the 21 included study floors  
D. Interventions 
a. Education A: An interactive dynamic learner-centric scenario-based  
education module with ongoing assessment, and immediate remediation 
(Dynamic). 
b. Education B: A linear static PowerPoint-based platform with voice-over but 
with no interactive component (Static).  
Participants will be assigned one of two education modules based on their permanent 
floor assignment.  The same education type will be assigned to all nurses on a single 
floor to mitigate issues related to contamination if nurses discuss the education with 
their colleagues. 
E. Enrollment 
a. Nurses will be identified using our centralized education directory that 
associates nurses with their designated departments and hospital floors. 
All nurses permanently assigned to one of the 21 included study floors will 
be included in this study. Nurses who are not permanently associated with 
one of the 21 hospital floors (e.g. traveling nurse, float nurse) will be 
excluded from this study. 
F. Randomization 
a. Nurses will be identified using our centralized education directory that 
associates nurses with their designated departments and hospital floors. 
Nurses will be cluster randomized by floor to receive one of two education 
modules about VTE prevention. Because of known differences between 
medical and surgical floors in VTE prophylaxis administration practice and 
culture, floors were stratified by department (i.e. medicine and surgery) for 
randomization. Within strata, we will use a coin toss to randomize floors 
into study arms. 
G. Duration of Study 
a. Nurses will be given three months to complete the assigned education 
module. Data will be collected for one full year to include medication 
administration practice at baseline, during the education trial, and after the 
education trial. 
 

H. Outcomes 
a. Primary Outcome measure: Proportion of non-administered doses of 
pharmacological VTE prophylaxis (dose level) 
b. Secondary Outcome Measures: 
i. Nurse-reported relevance of and satisfaction with the education 
modules 
ii. Proportion of doses documented as missed due to patient refusal 
(dose level) 
iii. Proportion of patients with any VTE (patient level) 
1. VTE are defined by AHRQ PSI-12 diagnosis codes 
iv. Proportion of patients with Deep Vein Thrombosis (DVT) (patient 
level) 
v. Proportion of patients with Pulmonary Embolism (PE) (patient level) 
 
Patient demographic data will be extracted from the Johns Hopkins Hospital 
administrative database. Pharmacologic VTE prophylaxis medication administration 
data will be extracted directly from electronic medication administration record in our 
computerized provider order entry system. Immediately following completion of the 
assigned education module, nurses will be asked to complete a voluntary 5-question 
survey to assess the relevance of and satisfaction with the education module. 
 
3. Analytic methods  
A. Baseline Characteristics 
a. Comparison of both arms to ensure similarity at baseline 
b. Descriptive analysis of baseline characteristics i.e. simple counts and 
proportions by trial arm 
 
B. Multi-level mixed effects linear regression 
Due to the complexity of the multilevel structure of the data (i.e. multiple doses per 
patient across various hospitalizations, nurses and floors), multiple outputation19 will be 
used to reduce the levels of hierarchical structure to the floor level and nurse level by 
randomly selecting one dosage per patient. By reiterating the procedure 1000 times, we 
will estimate the odds ratios (ORs) and 95% confidence intervals conditional on the floor 
and nurse. 
a. Primary analyses: Intent-to-Treat 
b. Secondary analyses 
i. Per protocol: Nurses who complete the education where the date of 
completion serves as an individual inflection point for pre-post 
education 
ii. Nurse-reported relevance of and satisfaction with the education 
modules will be analyzed using a two-sided Chi-squared test 

References 
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to Prevent Deep Vein Thrombosis and Pulmonary Embolism. 
http://www.ncbi.nlm.nih.gov/books/NBK44178/. Accessed April 5, 2014. 
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5,451 patients with ultrasound-confirmed deep vein thrombosis. The American Journal 
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3. Cohen AT, Tapson VF, Bergmann J, et al. Venous thromboembolism risk and 
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