Educating Nurses About Venous Thromboembolism (VTE) Prevention
Primary Purpose
Venous Thromboembolism, Venous Thrombosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse education in contemporary format
Nurse education in traditional format
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboembolism
Eligibility Criteria
Inclusion Criteria:
- Nurses on selected surgical and medical floors at Johns Hopkins Hospital
Exclusion Criteria:
- Nurses who were not permanently associated with one of the 21 hospital floors (e.g. traveling nurse, float nurse) were excluded from this study
Sites / Locations
- Johns Hopkins Medical Institutions
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Contemporary Education Format
Traditional Education Format
Arm Description
Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format. Intervention: Nurse education in contemporary format
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Rates of All VTE Among Hospitalized Patients
Did the intervention decrease rates of VTE among hospitalized patients?
Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients
Did the intervention decrease rates of DVT among hospitalized patients?
Rates of Pulmonary Embolism (PE) Among Hospitalized Patients
Did the intervention decrease rates of PE among hospitalized patients?
Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal
Did the intervention decrease rates of patient refusal of VTE prophylaxis medication doses among hospitalized patients?
Full Information
NCT ID
NCT02301793
First Posted
November 22, 2014
Last Updated
May 16, 2019
Sponsor
Johns Hopkins University
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02301793
Brief Title
Educating Nurses About Venous Thromboembolism (VTE) Prevention
Official Title
Educating Nurses About Venous Thromboembolism Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
March 31, 2015 (Actual)
Study Completion Date
March 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
BACKGROUND
In an attempt to improve venous thromboembolism (VTE) prophylaxis adherence the investigators carried out qualitative studies to obtain patients' viewpoints on how nurses should be educated about VTE prevention and to assess nurses' beliefs and perceptions about pharmacologic VTE prophylaxis
The investigators observed deficiencies in nurses' knowledge and misconceptions about VTE prophylaxis that likely lowers adherence to administration of prescribed VTE prophylaxis doses
As a part of our original Patient-Centered Outcomes Research Institute (PCORI) proposal, the investigators planned to educate nurses to address the observed deficiencies and misconceptions and improve their ability to communicate effectively with patients
Historically, nurse education has been done via a linear, PowerPoint-based platform with voice-over but with no interactive component (TRADITIONAL)
A newer platform for nurse education became available for use and includes scenario-based teaching, ongoing assessment, and immediate remediation. Most importantly, it is a highly interactive product (CONTEMPORARY)
STUDY DESIGN AND ANALYTIC PLAN
Research hypotheses
Primary: Nurse participants who receive either of these interventions will improve administration of prescribed VTE prophylaxis evidenced by a decrease in frequency of non-administered doses of VTE prophylaxis, compared with their frequency at baseline.
Secondary: Nurse participants who receive the contemporary education format will have a larger decrease in frequency of missed doses of VTE prophylaxis compared with those who participate in the traditional education format.
Study Design
Cluster Randomized Trial 21 floors, block randomized by floor type (medicine [n=11] vs. surgery [n=10]) and (ICU [n=5] vs. non-ICU [n=16]) All nurses on each floor are assigned the same education type to mitigate issues related to contamination if nurses discuss the education with their colleagues
Primary Outcome measure: Proportion of non-administered doses of pharmacological VTE prophylaxis (dose level)
Secondary Outcome Measures:
Proportion of doses documented as missed due to patient refusal (dose level)
Proportion of patients with any VTE (patient level)
Proportion of patients with Deep Vein Thrombosis (DVT) (patient level)
Proportion of patients with Pulmonary Embolism (PE) (patient level)
Analytic methods
Primary analyses - Intention-to-treat (includes all nurses assigned, whether or not they completed the education) Is there a difference between units allocated to either of the interventions comparing their outcome measure to their baseline measure? Is there a difference comparing those who received the contemporary education format vs. the traditional education format?
Secondary analysis - Per protocol (includes only nurses who completed the education) Do nurses who receive education perform better (improved administration of prescribed VTE prophylaxis) than those who did not? Do nurses who received the education in the contemporary format perform better than those who received it in the traditional format
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Venous Thrombosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
933 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contemporary Education Format
Arm Type
Experimental
Arm Description
Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.
Intervention: Nurse education in contemporary format
Arm Title
Traditional Education Format
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Nurse education in contemporary format
Intervention Description
Education about VTE was delivered through a web-based contemporary interactive format
Intervention Type
Behavioral
Intervention Name(s)
Nurse education in traditional format
Intervention Description
Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.
Primary Outcome Measure Information:
Title
Non Administration of Prescribed VTE Prophylaxis Medication Doses
Description
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
Time Frame
(Baseline); approximately 3 months later (Post-Education)
Secondary Outcome Measure Information:
Title
Rates of All VTE Among Hospitalized Patients
Description
Did the intervention decrease rates of VTE among hospitalized patients?
Time Frame
3-12 months after end of study
Title
Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients
Description
Did the intervention decrease rates of DVT among hospitalized patients?
Time Frame
3-12 months after end of study
Title
Rates of Pulmonary Embolism (PE) Among Hospitalized Patients
Description
Did the intervention decrease rates of PE among hospitalized patients?
Time Frame
3-12 months after end of study
Title
Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal
Description
Did the intervention decrease rates of patient refusal of VTE prophylaxis medication doses among hospitalized patients?
Time Frame
Baseline; approximately 3 months later (post education)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nurses on selected surgical and medical floors at Johns Hopkins Hospital
Exclusion Criteria:
Nurses who were not permanently associated with one of the 21 hospital floors (e.g. traveling nurse, float nurse) were excluded from this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliott R Haut, MD PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23799091
Citation
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.
Results Reference
background
PubMed Identifier
24681420
Citation
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.
Results Reference
background
PubMed Identifier
28813425
Citation
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.
Results Reference
derived
Links:
URL
http://www.pcori.org/research-in-action/improving-patient-nurse-communication-prevent-life-threatening-complication
Description
PCORI Website Page - "Improving Patient-Nurse Communication to Prevent a Life-Threatening Complication"
URL
http://www.pcori.org/research-results/2013/preventing-venous-thromboembolism-empowering-patients-and-enabling-patient
Description
PCORI Website Page - "Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient-Centered Care via Health Information Technology"
URL
https://www.hopkinsmedicine.org/armstrong_institute/improvement_projects/infections_complications/VTE/strategies.html
Description
Website to take the nurse education module. "Venous Thromboembolism Prevention: The Nurse's Perspective"
Learn more about this trial
Educating Nurses About Venous Thromboembolism (VTE) Prevention
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