Venous Thromboembolism, Venous Thrombosis
Conditions
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
Interventions
BEHAVIORALNurse education in contemporary format
Education about VTE was delivered through a web-based contemporary interactive format
BEHAVIORALNurse education in traditional format
Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.
Sponsors
Patient-Centered Outcomes Research Institute
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes 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.
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non Administration of Prescribed VTE Prophylaxis Medication Doses | (Baseline); approximately 3 months later (Post-Education) | 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
| Measure | Time frame | Description |
|---|---|---|
| Rates of All VTE Among Hospitalized Patients | 3-12 months after end of study | Did the intervention decrease rates of VTE among hospitalized patients? |
| Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients | 3-12 months after end of study | Did the intervention decrease rates of DVT among hospitalized patients? |
| Rates of Pulmonary Embolism (PE) Among Hospitalized Patients | 3-12 months after end of study | 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 | Baseline; approximately 3 months later (post education) | Did the intervention decrease rates of patient refusal of VTE prophylaxis medication doses among hospitalized patients? |
Countries
United States
Participant flow
Recruitment details
Nurses were identified using our centralized education directory that associates nurses with their designated departments and hospital floors. On July 23, 2014, nurses were cluster randomized by floor to receive one of two education modules about VTE prevention. Nurses were asked to complete their assigned education module by October 23, 2014.
Pre-assignment details
Pre Education Study Period reflects the baseline participants information (patient visits). Post Education Study Period reflects the participants information following the implementation of the nurse education intervention.
Participants by arm
| Arm | Count |
|---|---|
| Contemporary Education Format Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.
Intervention: Nurse education in contemporary format
Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format | 1,925 |
| Contemporary Education Format Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.
Intervention: Nurse education in contemporary format
Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format | 2,722 |
| Traditional Education 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
Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over. | 2,021 |
| Traditional Education 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
Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over. | 2,603 |
| Total | 9,271 |
Baseline characteristics
| Characteristic | Contemporary Education Format | Traditional Education Format | Total |
|---|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 16.9 | 56.3 years STANDARD_DEVIATION 17.3 | 56 years STANDARD_DEVIATION 17.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Patient Visit | 7 Patient Visit | 11 Patient Visit |
| Race (NIH/OMB) Asian | 46 Patient Visit | 50 Patient Visit | 96 Patient Visit |
| Race (NIH/OMB) Black or African American | 1106 Patient Visit | 980 Patient Visit | 2086 Patient Visit |
| Race (NIH/OMB) More than one race | 199 Patient Visit | 170 Patient Visit | 369 Patient Visit |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Patient Visit | 0 Patient Visit | 0 Patient Visit |
| Race (NIH/OMB) Unknown or Not Reported | 0 Patient Visit | 0 Patient Visit | 0 Patient Visit |
| Race (NIH/OMB) White | 1367 Patient Visit | 1396 Patient Visit | 2763 Patient Visit |
| Region of Enrollment United States | 2722 Patient Visit | 2603 Patient Visit | 5325 Patient Visit |
| Sex: Female, Male Female | 1435 Patient Visit | 1186 Patient Visit | 2621 Patient Visit |
| Sex: Female, Male Male | 1287 Patient Visit | 1417 Patient Visit | 2704 Patient Visit |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6,835 | 0 / 5,941 |
| other Total, other adverse events | 0 / 6,835 | 0 / 5,941 |
| serious Total, serious adverse events | 0 / 6,835 | 0 / 5,941 |
Outcome results
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
Time frame: (Baseline); approximately 3 months later (Post-Education)
Population: The total number of patient visits in each study arm. Overall number of participants represents the number of unique patients in the study. These numbers reflect patient visits at baseline and following the implementation of the nurse education intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contemporary Education Format | Non Administration of Prescribed VTE Prophylaxis Medication Doses | Pre-Education | 10.8 percentage of nonadministration |
| Contemporary Education Format | Non Administration of Prescribed VTE Prophylaxis Medication Doses | Post-Education | 9.2 percentage of nonadministration |
| Traditional Education Format | Non Administration of Prescribed VTE Prophylaxis Medication Doses | Pre-Education | 14.5 percentage of nonadministration |
| Traditional Education Format | Non Administration of Prescribed VTE Prophylaxis Medication Doses | Post-Education | 13.5 percentage of nonadministration |
Comparison: The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.p-value: 0.05Regression, Logistic
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?
Time frame: Baseline; approximately 3 months later (post education)
Population: The total number of patient visits in each study arm. Overall number of participants represents the number of unique patients in the study. These numbers reflect patient visits at baseline and following the implementation of the nurse education intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contemporary Education Format | Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal | Pre-Education | 5.6 percentage of patient refused doses |
| Contemporary Education Format | Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal | Post-Education | 5.1 percentage of patient refused doses |
| Traditional Education Format | Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal | Pre-Education | 7.3 percentage of patient refused doses |
| Traditional Education Format | Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal | Post-Education | 7.0 percentage of patient refused doses |
Comparison: The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.p-value: 0.05Regression, Logistic
Secondary
Rates of All VTE Among Hospitalized Patients
Did the intervention decrease rates of VTE among hospitalized patients?
Time frame: 3-12 months after end of study
Population: Data were not collected
Secondary
Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients
Did the intervention decrease rates of DVT among hospitalized patients?
Time frame: 3-12 months after end of study
Population: Data were not collected
Secondary
Rates of Pulmonary Embolism (PE) Among Hospitalized Patients
Did the intervention decrease rates of PE among hospitalized patients?
Time frame: 3-12 months after end of study
Population: Data were not collected