Clinical trial NCT02301793: Educating Nurses About Venous Thromboembolism (VTE) Prevention
Official title: Educating Nurses About Venous Thromboembolism Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Venous Thrombosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-11-26
Enrollment: 933
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Non Administration of Prescribed VTE Prophylaxis Medication Doses
timeFrame: (Baseline); approximately 3 months later (Post-Education)
Secondary outcomes:
measure: Rates of All VTE Among Hospitalized Patients
timeFrame: 3-12 months after end of study
measure: Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients
timeFrame: 3-12 months after end of study
measure: Rates of Pulmonary Embolism (PE) Among Hospitalized Patients
timeFrame: 3-12 months after end of study
measure: Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal
timeFrame: Baseline; approximately 3 months later (post education)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Elliott R Haut, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.