Venous Thrombosis (Disorder)ENACTNCT03367364
Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of VTE Prophylaxis
A study testing Patient education bundle (PEB), and Nurse feedback and coaching (NFC) in people with Venous Thrombosis (Disorder), run by Johns Hopkins University at 1 site in United States.
Trial summary
VTE associated harm is underappreciated among hospitalized patients and may be associated with missed doses of VTE prophylaxis medications. In order to ensure best practices, and administer a defect-free VTE prevention nurses must understand and educate patients on the importance of the VTE prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis (Disorder)
- What is being tested?
- Patient education bundle (PEB), and Nurse feedback and coaching (NFC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,657 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Eligible floors are defined as:
- All medical and surgical floors (non- intensive care units) B. 16 total floors (10 medicine, 6 surgery)
- Eligible Patients are defined as: All patients on assigned floors except:
- Patient data for those transferred between floors will be excluded. B. Patient data for those on floors during the cross-over time will be excluded.
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 Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of Venous Thromboembolism (VTE) Prophylaxis: A Crossover, Cluster Randomized Controlled Trial
VTE associated harm is underappreciated among hospitalized patients and may be associated with missed doses of VTE prophylaxis medications. In order to ensure best practices, and administer a defect-free VTE prevention nurses must understand and educate patients on the importance of the VTE prophylaxis. We propose to conduct a randomized trial comparing the effect of a validated, real-time patient education bundle (PEB), to a program of nurse feedback and coaching (NFC) provided by nurse leaders.
Read the detailed description
Missed doses of prescribed Venous Thromboembolism (VTE) pharmacologic prophylaxis is a significant problem. Data on patients admitted to The Johns Hopkins Hospital found approximately 12% of prescribed doses of pharmacologic VTE prophylaxis were not administered. There were several reasons for these missed doses. The leading reason (nearly 60% of missed doses) was patient or family member refusal for any reason.
Based on data collected by the Maryland Health Services Cost Review Commission (HSCRC) in the Maryland hospital-acquired conditions (MHAC) program, during 2011 half of patients who developed confirmed VTE at The Johns Hopkins Hospital were not administered one or more doses of prescribed VTE prophylaxis. These data indicate that missed or refused doses of VTE prophylaxis represent a significant and under-recognized contributor to sub-optimal VTE prophylaxis that will erode the beneficial impact of current efforts to improve rates of VTE prophylaxis ordering by physicians.
As part of a Patient-Centered Outcomes Research Institute (PCORI)-funded project, the investigators have developed a registry of missed doses of VTE prophylaxis that includes data on missed doses of VTE prophylaxis.
Primary hypothesis Both interventions (PEB and NFC) will improve medication administration (as measured by missed doses)
Secondary hypotheses
- Combining both interventions (PEB and NFC) will decrease patient refusal of VTE prophylaxis
- Combining both interventions (PEB and NFC) will decrease missed doses for reasons other than patient refusal
- Overall, PEB intervention will be more effective than NFC in reducing missed doses for any reason:
- The PEB intervention will be more effective than NFC in reducing in reducing patient refusal
- The NFC intervention will be more effective than PEB in reducing missed doses for other reasons of missed doses other than patient refusal
- There will be a differential effect on medicine and surgery floors
- There will be a differential effect by patient level characteristics (race, age, sex)
- There will be a differential effect on high vs. low performing floors
- There will be a differential effect dependent on pharmacological dosing regimen (i.e. medication, frequency)
- There will be an overall decline in the incidence of VTE events (all, DVT, PE)
Design A single institution, crossover, cluster randomized controlled trial (x-cRCT).
Intervention
In the PEB arm, the intervention will include:
A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video.
In the NFC arm, the intervention will include:
Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers.
- Conditions
- Venous Thrombosis (Disorder)
- Being tested
- Patient education bundle (PEB),, Nurse feedback and coaching (NFC)
- Keywords
- Venous Thromboembolism, Deep Venous Thrombosis, Clots
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education bundle (PEB),Behavioural
A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video.
Nurse feedback and coaching (NFC)Behavioural
Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers.
| Study group | Role | What they receive |
|---|---|---|
| Patient education bundle (PEB) | Active comparator | A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video. Receives: Behavioral: Patient education bundle (PEB), |
| Nurse feedback and coaching (NFC) | Placebo comparator | Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers. Receives: Behavioral: Nurse feedback and coaching (NFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Missed doses of VTE prophylaxis
Proportion of VTE prophylaxis doses not administered
Measured: 1 year
Secondary outcomes (5)
Patient refused doses of VTE prophylaxis
Proportion of VTE prophylaxis doses not administered due to patient/family refusal
Measured: 1 year
Missed doses of VTE prophylaxis for reasons other than patient refusal
Proportion of VTE prophylaxis doses not administered due to reasons other than patient/family refusal
Measured: 1 year
VTE events (all VTE, DVT, PE)
Proportion of VTE events recorded
Measured: 1 year
Patient satisfaction
surveys and HCAHPS scores
Measured: 1 year
Nurse Satisfaction
surveys
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Jan 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Venous Thrombosis (Disorder)Studies 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
- In the PEB arm, the intervention will include: A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video. In the NFC arm, the intervention will include: Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9,657 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
- NCT03367364
- Sponsor's protocol ID
- IRB00157201
- Other IDs
- DI-1603-34596
- Acronym
- ENACT
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2017
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28813425Lau BD, Streiff MB, Kraus PS, Hobson DB, Shaffer DL, Aboagye JK, Pronovost PJ, Haut ER. Missed Doses of Venous Thromboembolism (VTE) Prophylaxis at Community Hospitals: Cause for Alarm. J Gen Intern Med. 2018 Jan;33(1):19-20. doi: 10.1007/s11606-017-4203-y. No abstract available.
PubMed 29043537Streiff MB, Carolan HT, Hobson DB, Kraus PS, Holzmueller CG, Demski R, Lau BD, Biscup-Horn P, Pronovost PJ, Haut ER. Lessons from the Johns Hopkins Multi-Disciplinary Venous Thromboembolism (VTE) Prevention Collaborative. BMJ. 2012 Jun 19;344:e3935. doi: 10.1136/bmj.e3935.
PubMed 22718994Shermock 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 23799091Haut ER, Lau BD, Kraus PS, Hobson DB, Maheshwari B, Pronovost PJ, Streiff MB. Preventability of Hospital-Acquired Venous Thromboembolism. JAMA Surg. 2015 Sep;150(9):912-5. doi: 10.1001/jamasurg.2015.1340. No abstract available.
PubMed 26222738Streiff MB, Lau BD, Hobson DB, Kraus PS, Shermock KM, Shaffer DL, Popoola VO, Aboagye JK, Farrow NA, Horn PJ, Shihab HM, Pronovost PJ, Haut ER. The Johns Hopkins Venous Thromboembolism Collaborative: Multidisciplinary team approach to achieve perfect prophylaxis. J Hosp Med. 2016 Dec;11 Suppl 2:S8-S14. doi: 10.1002/jhm.2657.
PubMed 27925423Haut ER, Owodunni OP, Wang J, Shaffer DL, Hobson DB, Yenokyan G, Kraus PS, Farrow NE, Canner JK, Florecki KL, Webster KLW, Holzmueller CG, Aboagye JK, Popoola VO, Kia MV, Pronovost PJ, Streiff MB, Lau BD. Alert-Triggered Patient Education Versus Nurse Feedback for Nonadministered Venous Thromboembolism Prophylaxis Doses: A Cluster-Randomized Controlled Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e027119. doi: 10.1161/JAHA.122.027119. Epub 2022 Sep 1.
PubMed 36047732
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of Venous Thromboembolism (VTE) Prophylaxis: A Crossover, Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03367364
- Acronym / sponsor ID
- ENACT / IRB00157201
- Conditions
- Venous Thrombosis (Disorder)
- Keywords
- Venous Thromboembolism, Deep Venous Thrombosis, Clots
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,657 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VTE associated harm is underappreciated among hospitalized patients and may be associated with missed doses of VTE prophylaxis medications. In order to ensure best practices, and administer a defect-free VTE prevention nurses must understand and educate patients on the importance of the VTE prophylaxis. We propose to conduct a randomized trial comparing the effect of a validated, real-time patient education bundle (PEB), to a program of nurse feedback and coaching (NFC) provided by nurse leaders.
Detailed description
Missed doses of prescribed Venous Thromboembolism (VTE) pharmacologic prophylaxis is a significant problem. Data on patients admitted to The Johns Hopkins Hospital found approximately 12% of prescribed doses of pharmacologic VTE prophylaxis were not administered. There were several reasons for these missed doses. The leading reason (nearly 60% of missed doses) was patient or family member refusal for any reason.
Based on data collected by the Maryland Health Services Cost Review Commission (HSCRC) in the Maryland hospital-acquired conditions (MHAC) program, during 2011 half of patients who developed confirmed VTE at The Johns Hopkins Hospital were not administered one or more doses of prescribed VTE prophylaxis. These data indicate that missed or refused doses of VTE prophylaxis represent a significant and under-recognized contributor to sub-optimal VTE prophylaxis that will erode the beneficial impact of current efforts to improve rates of VTE prophylaxis ordering by physicians.
As part of a Patient-Centered Outcomes Research Institute (PCORI)-funded project, the investigators have developed a registry of missed doses of VTE prophylaxis that includes data on missed doses of VTE prophylaxis.
Primary hypothesis Both interventions (PEB and NFC) will improve medication administration (as measured by missed doses)
Secondary hypotheses
- Combining both interventions (PEB and NFC) will decrease patient refusal of VTE prophylaxis
- Combining both interventions (PEB and NFC) will decrease missed doses for reasons other than patient refusal
- Overall, PEB intervention will be more effective than NFC in reducing missed doses for any reason:
- The PEB intervention will be more effective than NFC in reducing in reducing patient refusal
- The NFC intervention will be more effective than PEB in reducing missed doses for other reasons of missed doses other than patient refusal
- There will be a differential effect on medicine and surgery floors
- There will be a differential effect by patient level characteristics (race, age, sex)
- There will be a differential effect on high vs. low performing floors
- There will be a differential effect dependent on pharmacological dosing regimen (i.e. medication, frequency)
- There will be an overall decline in the incidence of VTE events (all, DVT, PE)
Design A single institution, crossover, cluster randomized controlled trial (x-cRCT).
Intervention
In the PEB arm, the intervention will include:
A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video.
In the NFC arm, the intervention will include:
Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In the PEB arm, the intervention will include: A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video. In the NFC arm, the intervention will include: Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers.
| Arm | Type | Receives |
|---|---|---|
| Patient education bundle (PEB) | Active comparator | Behavioral: Patient education bundle (PEB),A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video. |
| Nurse feedback and coaching (NFC) | Placebo comparator | Behavioral: Nurse feedback and coaching (NFC)Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 education bundle (PEB),A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video. | Behavioural | Patient education bundle (PEB) |
| Nurse feedback and coaching (NFC)Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers. | Behavioural | Nurse feedback and coaching (NFC) |
Primary outcome
Missed doses of VTE prophylaxis
Time frame: 1 year
Proportion of VTE prophylaxis doses not administered
5 secondary outcomes
Patient refused doses of VTE prophylaxis
Time frame: 1 year
Missed doses of VTE prophylaxis for reasons other than patient refusal
Time frame: 1 year
VTE events (all VTE, DVT, PE)
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
Nurse Satisfaction
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: 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.
- Background: PubMed 29043537Lau BD, Streiff MB, Kraus PS, Hobson DB, Shaffer DL, Aboagye JK, Pronovost PJ, Haut ER. Missed Doses of Venous Thromboembolism (VTE) Prophylaxis at Community Hospitals: Cause for Alarm. J Gen Intern Med. 2018 Jan;33(1):19-20. doi: 10.1007/s11606-017-4203-y. No abstract available.
- Background: PubMed 22718994Streiff MB, Carolan HT, Hobson DB, Kraus PS, Holzmueller CG, Demski R, Lau BD, Biscup-Horn P, Pronovost PJ, Haut ER. Lessons from the Johns Hopkins Multi-Disciplinary Venous Thromboembolism (VTE) Prevention Collaborative. BMJ. 2012 Jun 19;344:e3935. doi: 10.1136/bmj.e3935.
- 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 26222738Haut ER, Lau BD, Kraus PS, Hobson DB, Maheshwari B, Pronovost PJ, Streiff MB. Preventability of Hospital-Acquired Venous Thromboembolism. JAMA Surg. 2015 Sep;150(9):912-5. doi: 10.1001/jamasurg.2015.1340. No abstract available.
- Background: PubMed 27925423Streiff MB, Lau BD, Hobson DB, Kraus PS, Shermock KM, Shaffer DL, Popoola VO, Aboagye JK, Farrow NA, Horn PJ, Shihab HM, Pronovost PJ, Haut ER. The Johns Hopkins Venous Thromboembolism Collaborative: Multidisciplinary team approach to achieve perfect prophylaxis. J Hosp Med. 2016 Dec;11 Suppl 2:S8-S14. doi: 10.1002/jhm.2657.
- Derived from this study: PubMed 36047732Haut ER, Owodunni OP, Wang J, Shaffer DL, Hobson DB, Yenokyan G, Kraus PS, Farrow NE, Canner JK, Florecki KL, Webster KLW, Holzmueller CG, Aboagye JK, Popoola VO, Kia MV, Pronovost PJ, Streiff MB, Lau BD. Alert-Triggered Patient Education Versus Nurse Feedback for Nonadministered Venous Thromboembolism Prophylaxis Doses: A Cluster-Randomized Controlled Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e027119. doi: 10.1161/JAHA.122.027119. Epub 2022 Sep 1.
- Individual participant dataSharing planned: No
Related trials for Venous Thrombosis (Disorder)
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
RecruitingObservational study
Danang Cerebral Venous Thrombosis Registry
Cerebral Venous Sinus Thrombosis, Stroke
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
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 education bundle (PEB), and Nurse feedback and coaching (NFC) in people with Venous Thrombosis (Disorder), 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?
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 2 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Missed doses of VTE prophylaxis (time frame: 1 year). 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 NCT03367364, which also lists 7 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 2 Mar 2023.