Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of Venous Thromboembolism (VTE) Prophylaxis: A Crossover, Cluster Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 9,657
- Locations
- 1
- Primary Endpoint
- Missed doses of VTE prophylaxis
Study Overview
Brief Summary
VTE associated harm is underappreciated among hospitalized patients and may be associated with missed doses of VTE prophylaxis medications. In order to ensure best practices, and administer a defect-free VTE prevention nurses must understand and educate patients on the importance of the VTE prophylaxis. We propose to conduct a randomized trial comparing the effect of a validated, real-time patient education bundle (PEB), to a program of nurse feedback and coaching (NFC) provided by nurse leaders.
Detailed Description
Missed doses of prescribed Venous Thromboembolism (VTE) pharmacologic prophylaxis is a significant problem. Data on patients admitted to The Johns Hopkins Hospital found approximately 12% of prescribed doses of pharmacologic VTE prophylaxis were not administered. There were several reasons for these missed doses. The leading reason (nearly 60% of missed doses) was patient or family member refusal for any reason.
Based on data collected by the Maryland Health Services Cost Review Commission (HSCRC) in the Maryland hospital-acquired conditions (MHAC) program, during 2011 half of patients who developed confirmed VTE at The Johns Hopkins Hospital were not administered one or more doses of prescribed VTE prophylaxis. These data indicate that missed or refused doses of VTE prophylaxis represent a significant and under-recognized contributor to sub-optimal VTE prophylaxis that will erode the beneficial impact of current efforts to improve rates of VTE prophylaxis ordering by physicians.
As part of a Patient-Centered Outcomes Research Institute (PCORI)-funded project, the investigators have developed a registry of missed doses of VTE prophylaxis that includes data on missed doses of VTE prophylaxis.
Primary hypothesis Both interventions (PEB and NFC) will improve medication administration (as measured by missed doses)
Secondary hypotheses
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Within strata, a coin toss (ERH) will be used to randomize floors into either the Patient education bundle arm or the Nurse feedback arm. The VTE prophylaxis medication non-administration dataset provided to the biostatistical team (i.e. outcomes assessors) for analysis will be blinded by treatment arm and department.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible floors are defined as:
- •A. All medical and surgical floors (non- intensive care units) B. 16 total floors (10 medicine, 6 surgery)
- •Eligible Patients are defined as: All patients on assigned floors except:
- •A. Patient data for those transferred between floors will be excluded. B. Patient data for those on floors during the cross-over time will be excluded.
Exclusion Criteria
- Not provided
Arms & Interventions
Patient education bundle (PEB)
A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video.
Intervention: Patient education bundle (PEB), (Behavioral)
Nurse feedback and coaching (NFC)
Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers.
Intervention: Nurse feedback and coaching (NFC) (Behavioral)
Outcomes
Primary Outcomes
Missed doses of VTE prophylaxis
Time Frame: 1 year
Proportion of VTE prophylaxis doses not administered
Secondary Outcomes
- Missed doses of VTE prophylaxis for reasons other than patient refusal(1 year)
- Patient refused doses of VTE prophylaxis(1 year)
- Patient satisfaction(1 year)
- Nurse Satisfaction(1 year)
- VTE events (all VTE, DVT, PE)(1 year)