Exploring the Benefits of Patient Education Bundle Following a Refusal vs. Nurses Feedback and Coaching in Preventing Missed Doses of Venous Thromboembolism (VTE) Prophylaxis

2017-12-13 08:34:07 | BioPortfolio


Harm associated with VTE is underappreciated among hospitalized patients and may be associated with missed doses of VTE prophylaxis medications which has many underlying causes. 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.


Missed doses of prescribed Venous Thromboembolism (VTE) pharmacologic prophylaxis is 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, we have developed a registry of missed doses of VTE prophylaxis that includes data on missed doses of VTE prophylaxis.

There are many possible approaches to combat these missed doses of VTE prophylaxis. We propose to implement two parallel quality improvements on medical and surgical in-patient units and compare the benefit of each approach to see if one is better than the other. We plan to randomly assign half the units to intervention A and half to intervention B, then crossover such that all units will be getting both interventions simultaneously.

Intervention A will be based upon a validated patient education bundle. We will implement an already validated patient-centered education bundle that delivers patient education materials in response to a patient refusal. When any dose is documented as not given, the charge nurse will speak with the bedside nurse and they will offer the patient an in-person, 1-on-1 discussion. Supporting education materials include a 2-page education sheet and an educational video.

Intervention B will be to provide bedside nurses directed data about their personal VTE prophylaxis administration. These data will be provided via nursing leadership (i.e. nursing directors, nurse managers) and may include on-on-one feedback and coaching.

STUDY DESIGN AND ANALYTIC PLAN Primary hypothesis Both interventions (PEB and NFC) will improve medication administration (as measured by missed doses)

Secondary hypotheses

1. Combining both interventions (PEB and NFC) will decrease patient refusal of VTE prophylaxis

2. Combining both interventions (PEB and NFC) will decrease missed doses for reasons other than patient refusal

3. Overall, PEB intervention will be more effective than NFC in reducing missed doses for any reason:

1. The PEB intervention will be more effective than NFC in reducing in reducing patient refusal

2. The NFC intervention will be more effective than PEB in reducing missed doses for other reasons of missed doses other than patient refusal

4. There will be a differential effect on medicine and surgery floors

5. There will be a differential effect by patient level characteristics (race, age, sex)

6. There will be a differential effect on high vs. low performing floors

7. There will be a differential effect dependent on pharmacological dosing regimen (i.e. medication, frequency)

8. There will be an overall decline in the incidence of VTE events (all, DVT, PE)

Study Design Cluster Randomized Trial 21 floors, block randomized by floor type (medicine [n=11] vs. surgery [n=10]) excluding ICU floors. All nurses and patients on each floor are assigned the same education type to mitigate issues related to contamination if nurses discuss the education with their colleagues.

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.

Primary Outcome:

Missed doses of VTE prophylaxis

Secondary outcomes:

Patient refused doses of VTE prophylaxis Missed doses of VTE prophylaxis for reasons other than patient refusal VTE events (all VTE, DVT, PE) Disparities ( race, sex, age) associated with VTE events and non-administration.

Analysis plan We will use the intention-to-treat (ITT) approach. We will compare outcomes across intervention periods. We will compare outcomes based upon randomized floor. We will use multiple outputation to reduce the levels of hierarchical structure to the floor and nurse level by randomly selecting one VTE prophylaxis dose per patient and reiterate the procedure 1000 times to bootstrap the p values for the comparisons.

We will adjust by floor type (medicine vs. surgery) and patient level characteristics (race, sex, age) when calculating proportions and risk of missed doses.

We will conduct a sensitivity analysis (excluding floors where prior intervention occurred).

Study Design


Venous Thromboembolism, Venous Thrombosis, Clots


Patient education bundle (PEB),, Nurse feedback and coaching (NFC)


Not yet recruiting


Johns Hopkins University

Results (where available)

View Results


Published on BioPortfolio: 2017-12-13T08:34:07-0500

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