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Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of Venous Thromboembolism (VTE) Prophylaxis (ENACT)

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ClinicalTrials.gov Identifier: NCT03367364
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Venous Thrombosis (Disorder) Behavioral: Patient education bundle (PEB), Behavioral: Nurse feedback and coaching (NFC) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (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.
Primary Purpose: Prevention
Official Title: Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of Venous Thromboembolism (VTE) Prophylaxis: A Crossover, Cluster Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : July 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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.

Placebo Comparator: 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.
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.




Primary Outcome Measures :
  1. Missed doses of VTE prophylaxis [ Time Frame: 1 year ]
    Proportion of VTE prophylaxis doses not administered


Secondary Outcome Measures :
  1. Patient refused doses of VTE prophylaxis [ Time Frame: 1 year ]
    Proportion of VTE prophylaxis doses not administered due to patient/family refusal

  2. Missed doses of VTE prophylaxis for reasons other than patient refusal [ Time Frame: 1 year ]
    Proportion of VTE prophylaxis doses not administered due to reasons other than patient/family refusal

  3. VTE events (all VTE, DVT, PE) [ Time Frame: 1 year ]
    Proportion of VTE events recorded

  4. Patient satisfaction [ Time Frame: 1 year ]
    surveys and HCAHPS scores

  5. Nurse Satisfaction [ Time Frame: 1 year ]
    surveys



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367364


Contacts
Contact: Elliott R Haut, MD. PhD 410‑502‑3122 ehaut1@jhmi.edu
Contact: Brandyn D Lau, MPD CPH 443-287-3031 blau2@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21287
Contact: Elliott R Haut, MD PhD    410-502-3122    ehaut1@jhmi.edu   
Contact: Brandyn D Lau, MPH CPH    443-287-3031      
Sponsors and Collaborators
Johns Hopkins University
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Elliott R Haut, MD. PhD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03367364     History of Changes
Other Study ID Numbers: IRB00157201
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Venous Thromboembolism, Deep Venous Thrombosis, Clots

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases