Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of VTE Prophylaxis

Study Overview
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Brief Summary
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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
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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 Combining both interventions (PEB and NFC) will decrease patient refusal of VTE prophylaxis Combining both interventions (PEB and NFC) will decrease missed doses for reasons other than patient refusal Overall, PEB intervention will be more effective than NFC in reducing missed doses for any reason: The PEB intervention will be more effective than NFC in reducing in reducing patient refusal The NFC intervention will be more effective than PEB in reducing missed doses for other reasons of missed doses other than patient refusal There will be a differential effect on medicine and surgery floors There will be a differential effect by patient level characteristics (race, age, sex) There will be a differential effect on high vs. low performing floors There will be a differential effect dependent on pharmacological dosing regimen (i.e. medication, frequency) There will be an overall decline in the incidence of VTE events (all, DVT, PE) Design A single institution, crossover, cluster randomized controlled trial (x-cRCT). Intervention In the PEB arm, the intervention will include: 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. In the NFC arm, the intervention will include: 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.

Official Title
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Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of Venous Thromboembolism (VTE) Prophylaxis: A Crossover, Cluster Randomized Controlled Trial

Conditions
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Venous Thrombosis (Disorder)

Intervention / Treatment
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* Behavioral: Patient education bundle (PEB),
* Behavioral: Nurse feedback and coaching (NFC)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In the PEB arm, the intervention will include: 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. In the NFC arm, the intervention will include: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient education bundle (PEB)<br>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. | Behavioral: Patient education bundle (PEB),<br>* 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.<br>|
| Placebo Comparator: Nurse feedback and coaching (NFC)<br>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. | Behavioral: Nurse feedback and coaching (NFC)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Missed doses of VTE prophylaxis | Proportion of VTE prophylaxis doses not administered | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient refused doses of VTE prophylaxis | Proportion of VTE prophylaxis doses not administered due to patient/family refusal | 1 year | 
| Missed doses of VTE prophylaxis for reasons other than patient refusal | Proportion of VTE prophylaxis doses not administered due to reasons other than patient/family refusal | 1 year | 
| VTE events (all VTE, DVT, PE) | Proportion of VTE events recorded | 1 year | 
| Patient satisfaction | surveys and HCAHPS scores | 1 year | 
| Nurse Satisfaction | surveys | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Thromboembolism, Deep Venous Thrombosis, Clots