NCT02301793

Brief Summary

As part of mandatory on-going nursing education, the investigators have incorporated identical information into two distinct web-based learning formats - the traditional linear PowerPoint format (with voice-over) and a new interactive format developed with central nursing education. The investigators will cluster randomize nurses by floor to receive either the traditional education or the new interactive education, and evaluate the impact on administration of VTE prophylaxis doses administered by nurses before and after education. All nurses on a floor will receive the same educational format. If one method of education results in statistically significant improvement in VTE prophylaxis administration, the investigators will cross over to deliver the superior education format to all nurses who originally were given the less effective method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
933

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

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

Study Start

First participant enrolled

April 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2015

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

May 17, 2019

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

12 months

First QC Date

November 22, 2014

Results QC Date

September 5, 2017

Last Update Submit

May 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Non Administration of Prescribed VTE Prophylaxis Medication Doses

    This is the percentage of VTE prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse

    (Baseline); approximately 3 months later (Post-Education)

Secondary Outcomes (4)

  • Rates of All VTE Among Hospitalized Patients

    3-12 months after end of study

  • Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients

    3-12 months after end of study

  • Rates of Pulmonary Embolism (PE) Among Hospitalized Patients

    3-12 months after end of study

  • Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal

    Baseline; approximately 3 months later (post education)

Study Arms (2)

Contemporary Education Format

EXPERIMENTAL

Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format. Intervention: Nurse education in contemporary format

Behavioral: Nurse education in contemporary format

Traditional Education Format

ACTIVE COMPARATOR

Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over. Intervention: Nurse education in traditional format

Behavioral: Nurse education in traditional format

Interventions

Education about VTE was delivered through a web-based contemporary interactive format

Contemporary Education Format

Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.

Traditional Education Format

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses on selected surgical and medical floors at Johns Hopkins Hospital

You may not qualify if:

  • Nurses who were not permanently associated with one of the 21 hospital floors (e.g. traveling nurse, float nurse) were excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

  • 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
  • Elder S, Hobson DB, Rand CS, Streiff MB, Haut ER, Efird LE, Kraus PS, Lehmann CU, Shermock KM. Hidden Barriers to Delivery of Pharmacological Venous Thromboembolism Prophylaxis: The Role of Nursing Beliefs and Practices. J Patient Saf. 2016 Jun;12(2):63-8. doi: 10.1097/PTS.0000000000000086.

    PMID: 24681420BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Venous ThromboembolismVenous Thrombosis

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosis

Limitations and Caveats

This trial was conducted in a single center potentially limiting the generalizability of our findings. The differences associated with education by specific clinical department in the current study was not explored.

Results Point of Contact

Title
Elliott R Haut M.D, PhD, Associate Professor of Surgery, Anesthesiology &Critical Care Medicine
Organization
Johns Hopkins Medical Institutions

Study Officials

  • Elliott R Haut, MD PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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) was used to randomize floors into either the Dynamic education arm or the Static education arm. Based on the outcome of the coin toss, nurses were then remotely assigned the online education module by an institutional nurse educator (DLS). The assigned educational module then appeared in the nurse's list of education assignments for completion within the institutional Learning Management System. Nurses are required to complete clinically relevant education regularly as part of ongoing professional practice and a waiver of consent was provided by the IRB; therefore nurses were not aware of their participation in a trial nor were they aware that two education modules existed. Additionally, the VTE prophylaxis medication non-administration dataset provided to the biostatistical team (i.e. outcomes assessors) for analysis was blinded by treatment arm and department.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: One arm was provided linear static education (Static) using PowerPoint slides with voiceover to cover the concepts. The other arm was provided interactive learner-centric dynamic scenario-based education (Dynamic), where each scenario resulted in either positive reinforcement or corrective feedback with an opportunity to apply knowledge to a new scenario.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2014

First Posted

November 26, 2014

Study Start

April 1, 2014

Primary Completion

March 31, 2015

Study Completion

March 31, 2015

Last Updated

May 17, 2019

Results First Posted

May 17, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations