Patient-Centered Education Bundle to Decrease Patient Refusal of Venous Thromboembolism (VTE) Prophylaxis
Phase: NA
Conditions: Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolism
Sponsor: Johns Hopkins University

Title:  
Education Bundle to Decrease Patient Refusal of Venous Thromboembolism 
Prophylaxis  
 
 
NCT02402881 
  
 
Registration: https://clinicaltrials.gov/ct2/show/NCT02402881  
 
 
Document date: October 10, 2018  
 
 
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  
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 
hospitals2,3 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.4-7 
Consequently, numerous interventions have been implemented to improve prescription 
of VTE prophylaxis7-10 with the implicit assumption that medications prescribed for 
hospitalized patients will always be administered.  
Deficits in  the Administration of Prescribed Venous Thromboembolism 
Prophylaxis   
Although the benefit of VTE prophylaxis is well established, many hospitalized patients 
do not receive adequate VTE prophylaxis. Studies from academic and community 
hospitals suggest that 10-20% of prescribed VTE prophylaxis doses are not 
administered, with the leading causing being patient refusal.11-15 In order to understand 
practice at our own institution, we conducted an exploratory study and found that nearly 
12% of prescribed doses of pharmacologic VTE prophylaxis are not administered and 
almost 60% of missed doses are due to patient or family member refusal.11 In a survey 
of 500 recently hospitalized patients, the National Blood Clot Alliance found that only 
28% and 15% respectively had basic knowledge of deep venous thrombosis (DVT) or 
pulmonary embolism (PE) despite the fact that 15% of participants had a history and 
43% had a family history of either condition. Similarly, we found that hospitalized 
patients have varying understanding and preferences regarding the harms of VTE and 
benefits of VTE prophylaxis.16  
Rationale for Patient-centered Education Bundle Trial  
Given the high frequency of patient refusal of VTE prophylaxis and significant 
knowledge gaps regarding VTE, there is an urgent need to educate patients and 
families on the importance and benefits of compliance with VTE prophylaxis. As a part 
of a study funded by the Patient-Centered Outcomes Research Institute (PCORI), we 
first educated nurses on the harms of VTE and the benefits of prophylaxis, showing that 
this first step intervention improved VTE prophylaxis administration by approximately 
10%.17 The patient-centered education bundle will be delivered as an in-person, 1-on-1 
discussion session with a nurse educator. Supporting education materials include a 
2page education sheet and an educational video.18  
Study Objectives and Hypotheses  
We hypothesize that patient refusal of VTE prophylaxis is associated with significant 
knowledge gaps among patients regarding their risk of developing VTE and the benefits 
of VTE prophylaxis, and that delivering an education bundle to patients who refuse VTE 
prophylaxis will improve acceptance of VTE prophylaxis and decrease rates of VTE.  

The objective of this study is to determine the effect of delivering a patient education 
intervention bundle on incidence of VTE prophylaxis non-administration, and on 
incidence of VTE in hospitalized patients.   
Primary Hypothesis: Patients on floors in the intervention arm will have a larger 
decrease in frequency of missed doses of VTE prophylaxis compared with patients on 
floors in the control arm.   
Secondary Hypothesis: Patients in the intervention arm will have a larger decrease in 
frequency of VTE compared with patients in the control arm.  
   
2. Study Design A. 
Study Design  
 Prospective cohort study  
  
B. Eligibility Criteria  
• 
All patients hospitalized on 16 medical/surgical (non-ICU) floors who are 
prescribed pharmacologic VTE prophylaxis will be eligible for inclusion  
• 
INTERVENTION: All patients on the four study floors (2 medical floors and 2 
surgical floors) who miss at least one dose of VTE prophylaxis will be eligible 
to receive the patient education bundle intervention  
• 
CONTROL: Patients on the 12 control floors (8 medical floors and 4 surgical 
floors) who miss doses of VTE prophylaxis will not receive the intervention  
• 
Patients who move between floors during their hospitalization (Intervention  
Control or Control  Intervention) will be excluded from analysis  
  
C. Interventions  
A patient-centered education bundle was created with input from key 
stakeholders including clinicians and patients. The bundle will be delivered 
inperson by a nurse educator. Patients may choose any one or a combination of 
components of the intervention including:   
• 
In-person, 1-on-1 discussion session with the nurse educator.   
• 
A two-page patient education paper   Patient education video  
  
D. Enrollment  
When a dose of VTE prophylaxis is documented by the nurse as not 
administered in the electronic medication administration record (eMAR), a 
realtime notification will be sent to the study team via pager and email. Upon 
receiving the alert, the nurse educator will engage the documenting bedside 
nurse to determine the cause for the missed dose. The nurse educator will then 
present the patient who missed a dose of pharmacologic VTE prophylaxis with 
the patient education bundle.  

  
E. Duration of Study   
The proposed intervention will be conducted over an 8-month period (April 1, 
2015 through December 31, 2015).   
  
We will use the 6-month period before the intervention (October 1, 2014 through 
March 31, 2015) as the pre-implementation data period.   
  
F. Outcomes  
a. Primary Outcome measure:  VTE prophylaxis non-administration  
b. Secondary Outcome Measures:  VTE (defined by AHRQ PSI-12 diagnosis 
codes)  
  
G. Data Source  
Patient demographic data and VTE outcomes will be extracted from the Johns 
Hopkins Hospital administrative database. Pharmacologic VTE prophylaxis 
medication administration data will be extracted directly from electronic medical 
administration record (eMAR).  
  
3. Analytic methods   
  
A. Blinding  
Our biostatistician team will be blinded to floor assignment arms.  
  
B. 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)  
  
C. Analytic Plan  
Our primary hypothesis will be evaluated by comparing VTE prophylaxis 
nonadministration before the intervention vs. during the intervention period. We 
will compare this change on intervention floors vs. control floors over the same 
period.   
  
D. 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 
outputation 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. For estimating 
conditional odds ratios and their confidence intervals, the binomial family and a 

logit link will be used, and for estimating the conditional proportions, the Poisson 
family and a log link will be used. An a priori stratified (or subgroup) analyses 
(medical vs. surgical floors) will be performed using the same models to assess  
the same outcomes. All analyses will be on an Intention-to-Treat basis (all doses 
and patients on each floor).  
  
 

  
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