Venous ThromboembolismNCT02402881
Education Bundle to Decrease Patient Refusal of VTE Prophylaxis
A study testing Patient-centered education bundle in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators have recently developed a registry of missed doses of VTE prophylaxis that includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE prophylaxis refusal, the group has developed a patient-centered education bundle that will be delivered as an in-person, 1-on-1… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolism
- What is being tested?
- Patient-centered education bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,652 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Nov 2018
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients on the four trial floors who miss at least one dose of VTE prophylaxis will be included in the study.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
About this study
Official title: Patient-Centered Education Bundle to Decrease Patient Refusal of Venous Thromboembolism (VTE) Prophylaxis
The investigators have recently developed a registry of missed doses of VTE prophylaxis that includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE prophylaxis refusal, the group has developed a patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page education sheet and an educational video.
The investigators hypothesize that patient refusal of VTE prophylaxis is associated with significant knowledge gaps among patients regarding patients' risk of developing VTE and the benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.
Read the detailed description
Background
This research group's published pilot study reported that nearly 12% of prescribed doses of pharmacologic VTE prophylaxis are not administered and almost 60% of missed doses are due to patient or family member refusal. Fanikos et al found that 44% of missed doses of VTE prophylaxis were due to patient refusal. In a survey of 500 recently hospitalized patients, the National Blood Clot Alliance found that only 28% and 15% respectively had basic knowledge of deep venous thrombosis (DVT) or pulmonary embolism (PE) despite the fact that 15% of participants had a history and 43% had a family history of either condition.
Given these high rates of patient refusal of VTE prophylaxis and significant knowledge gaps regarding VTE, there is an urgent need to educate patients and families on the importance and benefits of compliance with VTE prophylaxis.
The proposed patient-centered education bundle will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page education sheet and an educational video.
The investigators hypothesize that patient refusal of VTE prophylaxis is associated with significant knowledge gaps among patients regarding patients' risk of developing VTE and the benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.
Objectives
Primary objective: is to determine the impact of delivering a patient education intervention bundle on rates of VTE prophylaxis non-administration.
Secondary objective: is to determine the impact of delivering a patient education intervention bundle on rates of VTE.
Methods
The investigators have developed a real-time alert that notifies a member of the research team whenever a patient misses patients' dose of VTE prophylaxis. This interventional study will take place on on four hospital floors. Whenever a nurse educator receives an alert from any of the included floors indicating that a dose of VTE prophylaxis has been missed, she/he will visit the floor, and approach the nurse in charge of that patient to find out the reason for the missed dose. If the dose was missed as a result of patient refusal, the nurse educator will visit the patient and deliver the education bundle comprised of: 1) a one-on-one education session, 2) the patient education sheet and 3) the patient education video depending on patient preference. The intervention will be in real time for doses missed on business days between 8.00am and 4.00pm and at the start of the next business day for doses missed during non-business hours or on weekends. The investigators anticipate that the study will continue for 5 years and the investigators anticipate a total of 1000 patients during the study duration.
- Being tested
- Patient-centered education bundle
- Keywords
- venous thromboembolism, deep venous thrombosis, pulmonary embolism, blood clots
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-centered education bundleBehavioural
A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video. Receives: Behavioral: Patient-centered education bundle |
| Control | No intervention | Patients will receive only the standard practices of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses
This is the percentage of venous thromboembolism (VTE) prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse.
Measured: 15 Months
Secondary outcomes (1)
Number of Participants With Venous Thromboembolism
This is the number of participants with VTE events as documented in the electronic health record.
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2018
- Study completionNov 2018
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 (5)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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19,652 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
- NCT02402881
- Sponsor's protocol ID
- IRB00057117
- Status last verified
- Dec 2019
- First submitted
- 25 Mar 2015
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 23799091Fanikos J, Stevens LA, Labreche M, Piazza G, Catapane E, Novack L, Goldhaber SZ. Adherence to pharmacological thromboprophylaxis orders in hospitalized patients. Am J Med. 2010 Jun;123(6):536-41. doi: 10.1016/j.amjmed.2009.11.017.
PubMed 20569760Maynard GA, Varga EA, Friedman RJ, Brownstein AP, Ansell JE. Deep vein thrombosis and pulmonary embolism: Awareness and prophylaxis practices reported by recently hospitalized patients. Society of Hospital Medicine Annual Meeting. 2011
Owodunni OP, Lau BD, Wang J, Shaffer DL, Kraus PS, Holzmueller CG, Aboagye JK, Hobson DB, Varasteh Kia M, Armocida S, Streiff MB, Haut ER. Effectiveness of a Patient Education Bundle on Venous Thromboembolism Prophylaxis Administration by Sex. J Surg Res. 2022 Dec;280:151-162. doi: 10.1016/j.jss.2022.07.015. Epub 2022 Aug 12.
PubMed 35969933Haut ER, Aboagye JK, Shaffer DL, Wang J, Hobson DB, Yenokyan G, Sugar EA, Kraus PS, Farrow NE, Canner JK, Owodunni OP, Florecki KL, Webster KLW, Holzmueller CG, Pronovost PJ, Streiff MB, Lau BD. Effect of Real-time Patient-Centered Education Bundle on Administration of Venous Thromboembolism Prevention in Hospitalized Patients. JAMA Netw Open. 2018 Nov 2;1(7):e184741. doi: 10.1001/jamanetworkopen.2018.4741.
PubMed 30646370
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Education Bundle to Decrease Patient Refusal of Venous Thromboembolism (VTE) Prophylaxis
- ClinicalTrials.gov ID
- NCT02402881
- Acronym / sponsor ID
- IRB00057117
- Keywords
- venous thromboembolism, deep venous thrombosis, pulmonary embolism, blood clots
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19,652 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Apr 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have recently developed a registry of missed doses of VTE prophylaxis that includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE prophylaxis refusal, the group has developed a patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page education sheet and an educational video.
The investigators hypothesize that patient refusal of VTE prophylaxis is associated with significant knowledge gaps among patients regarding patients' risk of developing VTE and the benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.
Detailed description
Background
This research group's published pilot study reported that nearly 12% of prescribed doses of pharmacologic VTE prophylaxis are not administered and almost 60% of missed doses are due to patient or family member refusal. Fanikos et al found that 44% of missed doses of VTE prophylaxis were due to patient refusal. In a survey of 500 recently hospitalized patients, the National Blood Clot Alliance found that only 28% and 15% respectively had basic knowledge of deep venous thrombosis (DVT) or pulmonary embolism (PE) despite the fact that 15% of participants had a history and 43% had a family history of either condition.
Given these high rates of patient refusal of VTE prophylaxis and significant knowledge gaps regarding VTE, there is an urgent need to educate patients and families on the importance and benefits of compliance with VTE prophylaxis.
The proposed patient-centered education bundle will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page education sheet and an educational video.
The investigators hypothesize that patient refusal of VTE prophylaxis is associated with significant knowledge gaps among patients regarding patients' risk of developing VTE and the benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.
Objectives
Primary objective: is to determine the impact of delivering a patient education intervention bundle on rates of VTE prophylaxis non-administration.
Secondary objective: is to determine the impact of delivering a patient education intervention bundle on rates of VTE.
Methods
The investigators have developed a real-time alert that notifies a member of the research team whenever a patient misses patients' dose of VTE prophylaxis. This interventional study will take place on on four hospital floors. Whenever a nurse educator receives an alert from any of the included floors indicating that a dose of VTE prophylaxis has been missed, she/he will visit the floor, and approach the nurse in charge of that patient to find out the reason for the missed dose. If the dose was missed as a result of patient refusal, the nurse educator will visit the patient and deliver the education bundle comprised of: 1) a one-on-one education session, 2) the patient education sheet and 3) the patient education video depending on patient preference. The intervention will be in real time for doses missed on business days between 8.00am and 4.00pm and at the start of the next business day for doses missed during non-business hours or on weekends. The investigators anticipate that the study will continue for 5 years and the investigators anticipate a total of 1000 patients during the study duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Patient-centered education bundleA patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video. |
| Control | No intervention | –Patients will receive only the standard practices of care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients on the four trial floors who miss at least one dose of VTE prophylaxis will be included in the study.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Patient-centered education bundleA patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video. | Behavioural | Intervention |
Primary outcome
Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses
Time frame: 15 Months
This is the percentage of venous thromboembolism (VTE) prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse.
1 secondary outcome
Number of Participants With Venous Thromboembolism
Time frame: 15 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- 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 20569760Fanikos J, Stevens LA, Labreche M, Piazza G, Catapane E, Novack L, Goldhaber SZ. Adherence to pharmacological thromboprophylaxis orders in hospitalized patients. Am J Med. 2010 Jun;123(6):536-41. doi: 10.1016/j.amjmed.2009.11.017.
- BackgroundMaynard GA, Varga EA, Friedman RJ, Brownstein AP, Ansell JE. Deep vein thrombosis and pulmonary embolism: Awareness and prophylaxis practices reported by recently hospitalized patients. Society of Hospital Medicine Annual Meeting. 2011
- Derived from this study: PubMed 35969933Owodunni OP, Lau BD, Wang J, Shaffer DL, Kraus PS, Holzmueller CG, Aboagye JK, Hobson DB, Varasteh Kia M, Armocida S, Streiff MB, Haut ER. Effectiveness of a Patient Education Bundle on Venous Thromboembolism Prophylaxis Administration by Sex. J Surg Res. 2022 Dec;280:151-162. doi: 10.1016/j.jss.2022.07.015. Epub 2022 Aug 12.
- Derived from this study: PubMed 30646370Haut ER, Aboagye JK, Shaffer DL, Wang J, Hobson DB, Yenokyan G, Sugar EA, Kraus PS, Farrow NE, Canner JK, Owodunni OP, Florecki KL, Webster KLW, Holzmueller CG, Pronovost PJ, Streiff MB, Lau BD. Effect of Real-time Patient-Centered Education Bundle on Administration of Venous Thromboembolism Prevention in Hospitalized Patients. JAMA Netw Open. 2018 Nov 2;1(7):e184741. doi: 10.1001/jamanetworkopen.2018.4741.
- PCORI Website Page - "Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient-Centered Care via Health Information Technology"Link provided by the sponsor.
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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 Patient-centered education bundle in people with Venous Thromboembolism and Deep 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 6 Jan 2020. 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 6 Jan 2020). 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?
Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses (time frame: 15 Months). 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 NCT02402881, which also lists 5 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 6 Jan 2020.