Venous ThromboembolismNCT02301793
Educating Nurses About Venous Thromboembolism (VTE) Prevention
A study testing Nurse education in contemporary format and Nurse education in traditional format in people with Venous Thromboembolism and Venous Thrombosis, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolism, Venous Thrombosis
- What is being tested?
- Nurse education in contemporary format and Nurse education in traditional format
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 933 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2014to 31 Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nurses on selected surgical and medical floors at Johns Hopkins Hospital
Who cannot join
- Nurses who were not permanently associated with one of the 21 hospital floors (e.g. traveling nurse, float nurse) were excluded from this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
About this study
Official title: Educating Nurses About Venous Thromboembolism Prevention
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.
Read the 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
- Conditions
- Venous Thromboembolism, Venous Thrombosis
- Being tested
- Nurse education in contemporary format, Nurse education in traditional format
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse education in contemporary formatBehavioural
Education about VTE was delivered through a web-based contemporary interactive format
Nurse education in traditional formatBehavioural
Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: 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 Receives: Behavioral: Nurse education in traditional format |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: (Baseline); approximately 3 months later (Post-Education)
Secondary outcomes (4)
Rates of All VTE Among Hospitalized Patients
Did the intervention decrease rates of VTE among hospitalized patients?
Measured: 3-12 months after end of study
Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients
Did the intervention decrease rates of DVT among hospitalized patients?
Measured: 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?
Measured: 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?
Measured: Baseline; approximately 3 months later (post education)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study start1 Apr 2014
- Primary completion31 Mar 2015
- Study completion31 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 933 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Elliott R Haut, MD PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301793
- Sponsor's protocol ID
- NA_00043860
- Status last verified
- May 2019
- First submitted
- 22 Nov 2014
- Last updated
- 17 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23799091Elder 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.
PubMed 24681420Lau 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.
PubMed 28813425
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educating Nurses About Venous Thromboembolism Prevention
- ClinicalTrials.gov ID
- NCT02301793
- Acronym / sponsor ID
- NA_00043860
- Conditions
- Venous Thromboembolism, Venous Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 933 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Posted 17 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Contemporary Education Format | Experimental | Behavioral: Nurse education in contemporary formatNurses 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 | Behavioral: Nurse education in traditional formatNurses 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Nurses on selected surgical and medical floors at Johns Hopkins Hospital
Key exclusion criteria (1 listed)
- Nurses who were not permanently associated with one of the 21 hospital floors (e.g. traveling nurse, float nurse) were excluded from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse education in contemporary formatEducation about VTE was delivered through a web-based contemporary interactive format | Behavioural | Contemporary Education Format |
| Nurse education in traditional formatEducation about VTE was delivered through a web-based traditional linear Powerpoint format with voice over. | Behavioural | Traditional Education Format |
Primary outcome
Non Administration of Prescribed VTE Prophylaxis Medication Doses
Time frame: (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
4 secondary outcomes
Rates of All VTE Among Hospitalized Patients
Time frame: 3-12 months after end of study
Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients
Time frame: 3-12 months after end of study
Rates of Pulmonary Embolism (PE) Among Hospitalized Patients
Time frame: 3-12 months after end of study
Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal
Time frame: Baseline; approximately 3 months later (post education)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23799091Shermock 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.
- Background: PubMed 24681420Elder 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.
- Derived from this study: PubMed 28813425Lau 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.
- PCORI Website Page - "Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient-Centered Care via Health Information Technology"Link provided by the sponsor.
- Website to take the nurse education module. "Venous Thromboembolism Prevention: The Nurse's Perspective"Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliott R Haut, MD PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse education in contemporary format and Nurse education in traditional format in people with Venous Thromboembolism and Venous Thrombosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non Administration of Prescribed VTE Prophylaxis Medication Doses (time frame: (Baseline); approximately 3 months later (Post-Education)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301793, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019; AzTrials last refreshed its copy on 29 Oct 2026.