Education Bundle to Decrease Patient Refusal of VTE Prophylaxis

Study Overview
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Brief Summary
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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 patients' 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.

Detailed Description
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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 patients' 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 patients' 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. The investigators anticipate that the study will continue for 5 years and the investigators anticipate a total of 1000 patients during the study duration.

Official Title
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Patient-Centered Education Bundle to Decrease Patient Refusal of Venous Thromboembolism (VTE) Prophylaxis

Conditions
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Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolism

Intervention / Treatment
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* Behavioral: Patient-centered education bundle


Participation Criteria
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Eligibility Criteria
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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: N/A

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 patient education sheet and a patient education video. | Behavioral: Patient-centered education bundle<br>* 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 patient education sheet and a patient education video.<br>|
| No Intervention: Control<br>Patients will receive only the standard practices of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses | This is the percentage of venous thromboembolism (VTE) prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse. | 15 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Venous Thromboembolism | This is the number of participants with VTE events as documented in the electronic health record. | 15 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep venous thrombosis, venous thromboembolism, pulmonary embolism, blood clots