NCT03367364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,657

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

March 2, 2023

Status Verified

December 1, 2021

Enrollment Period

10 months

First QC Date

December 5, 2017

Last Update Submit

March 1, 2023

Conditions

Venous Thrombosis (Disorder)

Keywords

Venous Thromboembolism, Deep Venous Thrombosis, Clots

Outcome Measures

Primary Outcomes (1)

  • Missed doses of VTE prophylaxis

    Proportion of VTE prophylaxis doses not administered

    1 year

Secondary Outcomes (5)

  • Patient refused doses of VTE prophylaxis

    1 year

  • Missed doses of VTE prophylaxis for reasons other than patient refusal

    1 year

  • VTE events (all VTE, DVT, PE)

    1 year

  • Patient satisfaction

    1 year

  • Nurse Satisfaction

    1 year

Study Arms (2)

Patient education bundle (PEB)

ACTIVE COMPARATOR

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),

Nurse feedback and coaching (NFC)

PLACEBO COMPARATOR

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)

Interventions

Patient education bundle (PEB),BEHAVIORAL

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.

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

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.

Nurse feedback and coaching (NFC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

Related Publications (7)

  • Lau BD, Shaffer DL, Hobson DB, Yenokyan G, Wang J, Sugar EA, Canner JK, Bongiovanni D, Kraus PS, Popoola VO, Shihab HM, Farrow NE, Aboagye JK, Pronovost PJ, Streiff MB, Haut ER. Effectiveness of two distinct web-based education tools for bedside nurses on medication administration practice for venous thromboembolism prevention: A randomized clinical trial. PLoS One. 2017 Aug 16;12(8):e0181664. doi: 10.1371/journal.pone.0181664. eCollection 2017.

    PMID: 28813425BACKGROUND

  • Lau BD, Streiff MB, Kraus PS, Hobson DB, Shaffer DL, Aboagye JK, Pronovost PJ, Haut ER. Missed Doses of Venous Thromboembolism (VTE) Prophylaxis at Community Hospitals: Cause for Alarm. J Gen Intern Med. 2018 Jan;33(1):19-20. doi: 10.1007/s11606-017-4203-y. No abstract available.

    PMID: 29043537BACKGROUND

  • Streiff MB, Carolan HT, Hobson DB, Kraus PS, Holzmueller CG, Demski R, Lau BD, Biscup-Horn P, Pronovost PJ, Haut ER. Lessons from the Johns Hopkins Multi-Disciplinary Venous Thromboembolism (VTE) Prevention Collaborative. BMJ. 2012 Jun 19;344:e3935. doi: 10.1136/bmj.e3935.

    PMID: 22718994BACKGROUND

  • Shermock KM, Lau BD, Haut ER, Hobson DB, Ganetsky VS, Kraus PS, Efird LE, Lehmann CU, Pinto BL, Ross PA, Streiff MB. Patterns of non-administration of ordered doses of venous thromboembolism prophylaxis: implications for novel intervention strategies. PLoS One. 2013 Jun 14;8(6):e66311. doi: 10.1371/journal.pone.0066311. Print 2013.

    PMID: 23799091BACKGROUND

  • Haut ER, Lau BD, Kraus PS, Hobson DB, Maheshwari B, Pronovost PJ, Streiff MB. Preventability of Hospital-Acquired Venous Thromboembolism. JAMA Surg. 2015 Sep;150(9):912-5. doi: 10.1001/jamasurg.2015.1340. No abstract available.

    PMID: 26222738BACKGROUND

  • Streiff MB, Lau BD, Hobson DB, Kraus PS, Shermock KM, Shaffer DL, Popoola VO, Aboagye JK, Farrow NA, Horn PJ, Shihab HM, Pronovost PJ, Haut ER. The Johns Hopkins Venous Thromboembolism Collaborative: Multidisciplinary team approach to achieve perfect prophylaxis. J Hosp Med. 2016 Dec;11 Suppl 2:S8-S14. doi: 10.1002/jhm.2657.

    PMID: 27925423BACKGROUND

  • Haut ER, Owodunni OP, Wang J, Shaffer DL, Hobson DB, Yenokyan G, Kraus PS, Farrow NE, Canner JK, Florecki KL, Webster KLW, Holzmueller CG, Aboagye JK, Popoola VO, Kia MV, Pronovost PJ, Streiff MB, Lau BD. Alert-Triggered Patient Education Versus Nurse Feedback for Nonadministered Venous Thromboembolism Prophylaxis Doses: A Cluster-Randomized Controlled Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e027119. doi: 10.1161/JAHA.122.027119. Epub 2022 Sep 1.

    PMID: 36047732DERIVED

MeSH Terms

Conditions

Venous ThrombosisVenous Thromboembolism

Interventions

BEP protocol

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThromboembolism

Study Officials

  • Elliott R Haut, MD. PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 8, 2017

Study Start

January 1, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

March 2, 2023

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)