Patient-Centered Education Bundle to Decrease Patient Refusal of Venous Thromboembolism (VTE) Prophylaxis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 19,652
- Locations
- 1
- Primary Endpoint
- Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
Intervention
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.
Intervention: Patient-centered education bundle (Behavioral)
Control
Patients will receive only the standard practices of care
Outcomes
Primary Outcomes
Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses
Time Frame: 15 Months
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.
Secondary Outcomes
- Number of Participants With Venous Thromboembolism(15 Months)