Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of Venous Thromboembolism (VTE) Prophylaxis
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/10/2019 |
| Start Date: | January 1, 2018 |
| End Date: | January 1, 2020 |
| Contact: | Elliott R Haut, MD. PhD |
| Email: | ehaut1@jhmi.edu |
| Phone: | 410‑502‑3122 |
Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of Venous Thromboembolism (VTE) Prophylaxis: A Crossover, Cluster Randomized Controlled Trial
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.
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.
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
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)
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.
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
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)
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.
1. Eligible floors are defined as:
A. All medical and surgical floors (non- intensive care units) B. 16 total floors (10
medicine, 6 surgery)
2. 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.
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