Education Bundle to Decrease Patient Refusal of VTE Prophylaxis



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 100
Updated:2/14/2019
Start Date:April 2015
End Date:April 2020
Contact:Elliott R Haut, MD PhD
Email:ehaut1@jhmi.edu
Phone:410‑502‑3122

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Patient-centered Education Bundle to Decrease Patient Refusal of Venous Thromboembolism Prophylaxis

The investigators have recently developed a registry of missed doses of VTE prophylaxis that
includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE
prophylaxis refusal, the group has developed a patient-centered education bundle that will be
delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting
education materials include a 2-page education sheet and an educational video.

The investigators 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 that refuse
VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.

Background

This research group's published pilot study reported 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. Fanikos et al found that 44% of missed doses of VTE
prophylaxis were due to patient refusal. 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.

Given these high rates 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.

The proposed 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 2-page
education sheet and an educational video.

The investigators 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 that refuse
VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.

Objectives

Primary objective: is to determine the impact of delivering a patient education intervention
bundle on rates of VTE prophylaxis non-administration.

Secondary objective: is to determine the impact of delivering a patient education
intervention bundle on rates of VTE.

Methods

The investigators have developed a real-time alert that notifies a member of the research
team whenever a patient misses their dose of VTE prophylaxis. This interventional study will
take place on on four hospital floors. Whenever a nurse educator receives an alert from any
of the included floors indicating that a dose of VTE prophylaxis has been missed, she/he will
visit the floor, and approach the nurse in charge of that patient to find out the reason for
the missed dose. If the dose was missed as a result of patient refusal, the nurse educator
will visit the patient and deliver the education bundle comprised of: 1) a one-on-one
education session, 2) the patient education sheet and 3) the patient education video
depending on patient preference. The intervention will be in real time for doses missed on
business days between 8.00am and 4.00pm and at the start of the next business day for doses
missed during non-business hours or on weekends. We anticipate that the study will continue
for 5 years and we anticipate a total of 1000 patients during the study duration

Inclusion Criteria:

- All patients on the four trial floors who miss at least one dose of VTE prophylaxis
will be included in the study.

Exclusion Criteria:
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Baltimore, Maryland 21287
Phone: 410-502-3122
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