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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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
STUDY DESIGN AND ANALYTIC PLAN
Research hypotheses
Study Design
Primary Outcome measure: Proportion of non-administered doses of pharmacological VTE prophylaxis (dose level)
Secondary Outcome Measures:
Analytic methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse education in contemporary format | Behavioral | Education about VTE was delivered through a web-based contemporary interactive format |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of All VTE Among Hospitalized Patients | Did the intervention decrease rates of VTE among hospitalized patients? | 3-12 months after end of study |
| Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliott R Haut, MD PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutions | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23799091 | Background | 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. | |
| 24681420 |
| Label | URL |
|---|---|
| PCORI Website Page - "Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient-Centered Care via Health Information Technology" | View source |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre Education Study Period |
| |||||||||||||
| During and Post Education Study Period |
|
Outcomes assessed were analyzed on patient visit level as each encounter represents a unique participant outcome. Patient A might receive all doses during their first visit and miss doses during a second visit. Patient A might have been in different Arms during different visits. Baseline information was only collected during the pre-education phase
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentage of nonadministration | (Baseline); approximately 3 months later (Post-Education) | patient visits | patient visits |
|
1 year
Adverse events were reported at patient visit level
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elliott R Haut M.D, PhD, Associate Professor of Surgery, Anesthesiology &Critical Care Medicine | Johns Hopkins Medical Institutions | 410-502-3122 | ehaut1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2015 | Feb 15, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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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.
| Nurse education in traditional format | Behavioral | Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over. |
|
Did the intervention decrease rates of DVT among hospitalized patients?
| 3-12 months after end of study |
| 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 |
| 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) |
| 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. |
| 28813425 | Derived | 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. |
| NOT COMPLETED |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| Patient Visit |
|
| years |
| Patient Visit |
|
| Sex: Female, Male | The numbers of patients were 2,722 and 2603, in the dynamic and static groups respectively. While the unique number of patients were 1925, and 2021 respectively. | Count of Units | Patient Visit | Patient Visit |
|
| Race (NIH/OMB) | Count of Units | Patient Visit | Patient Visit |
|
| Region of Enrollment | Number | Patient Visit | Patient Visit |
|
| OG001 | 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. |
|
|
|
| Secondary | Rates of All VTE Among Hospitalized Patients | Did the intervention decrease rates of VTE among hospitalized patients? | Data were not collected | Posted | 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? | Data were not collected | Posted | 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? | Data were not collected | Posted | 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? | 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. | Posted | Number | 95% Confidence Interval | percentage of patient refused doses | Baseline; approximately 3 months later (post education) | patient visits | patient visits |
|
|
|
|
| 0 |
| 6,835 |
| 0 |
| 6,835 |
| 0 |
| 6,835 |
| EG001 | 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. | 0 | 5,941 | 0 | 5,941 | 0 | 5,941 |
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| D013927 |
| Thrombosis |
|
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| Post-Education |
|
|
| Other |