Educating Nurses About Venous Thromboembolism (VTE) Prevention

Venous Thromboembolism Clinical Trial

Official title:

Educating Nurses About Venous Thromboembolism Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301793
• Other study ID #: NA_00043860
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: March 31, 2015

Study information

• Verified date: May 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 933
• Est. completion date: March 31, 2015
• Est. primary completion date: March 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Behavioral:
• Nurse education in contemporary format
Education about VTE was delivered through a web-based contemporary interactive format
• Nurse education in traditional format
Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates of All VTE Among Hospitalized Patients	Did the intervention decrease rates of VTE among hospitalized patients?	3-12 months after end of study
Secondary	Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients	Did the intervention decrease rates of DVT among hospitalized patients?	3-12 months after end of study
Secondary	Rates of Pulmonary Embolism (PE) Among Hospitalized Patients	Did the intervention decrease rates of PE among hospitalized patients?	3-12 months after end of study
Secondary	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?	Baseline; approximately 3 months later (post education)

External Links

•   PCORI Website Page - "Improving Patient-Nurse Communication to Prevent a Life-Threatening Complication"
•   PCORI Website Page - "Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient-Centered Care via Health Information Technology"
•   Website to take the nurse education module. "Venous Thromboembolism Prevention: The Nurse's Perspective"