ThromboembolismNCT05548010
Venous Thromboembolism (VTE) Knowledge
An observational study of Thromboembolism, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Venous thromboembolism (VTE) is common especially among post-operative patients, and its occurrence is associated with significant morbidity and mortality. VTE is highly preventable with prophylactic modalities ranging from conservative measures such as early mobilization, to mechanical prophylaxis such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolism
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Nov 2022to 4 Aug 2024
- Phase
- Observational
- 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
Study population: The first group will be adult patients age >18 scheduled for surgical operations. The second group will be the HCPs directedly involve in patients care of these surgical patients.
Who may be able to join
- Capable of providing written informed consent and willing and able to adhere to all protocol requirements
- Male or female at least 18 years of age at the time of providing written informed consent
- Adult patients age >18 scheduled for surgical operations
- Healthcare Providers directedly involve in patients care of these surgical patients.
Who cannot join
- Unable to make their own informed consent
- Unable to understand the study protocol
- Visually or auditorily impaired.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Short Educational Materials in Improving the Knowledge Level of Venous Thromboembolism and the Compliance of Thromboprophylaxis in Post-operative Patients: a Prospective Study
Venous thromboembolism (VTE) is common especially among post-operative patients, and its occurrence is associated with significant morbidity and mortality. VTE is highly preventable with prophylactic modalities ranging from conservative measures such as early mobilization, to mechanical prophylaxis such as intermittent pneumatic compression (ICP), to pharmacological prophylaxis such as peri-operative anticoagulation. Despite established guidelines from various professional societies, the practice of VTE prophylaxis varied greatly from institute to institute. Evidence suggests that there is a significant gap between the optimal thromboprophylaxis as suggested by experts and real-work practice. Many healthcare-providers (HCP) and patients at risk of VTE are either not aware of the risk of VTE or not confident to apply the necessary thromboprophylaxis. The knowledge level of VTE appears to play a key role in affecting the level of compliance to the optimal thromboprophylaxis. Considerable improvement in VTE prophylaxis utilization may result from the implementation of a multifaceted educational program. By improving patient's awareness on VTE prophylaxis, the incidence of DVT might be reduced. The knowledge level of patients can be improved by various means including educational video, administrative measures, or continue medical education program. However, no prospective study has been performed to assess the impact of an educational program on the VTE knowledge level among post-operative patients and their HCP, and if any improvement of their knowledge level can be translated to a better adherence to VTE prophylaxis guidelines. We therefore propose to conduct a prospective non-randomized controlled study to evaluate the effect of an education materials for the patients as well as their HCP on their knowledge level as well as the utilization and adherence of VTE prophylaxis in these patients by comparing two groups of patients and HCP.
- Conditions
- Thromboembolism
- Being tested
- No intervention as this is an observational study
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention as this is an observational studyOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Patients >18years old with scheduled operation Receives: Other: No intervention as this is an observational study | |
| Healthcare Professionals (HCP) | HCP of the enrolled subjects Receives: Other: No intervention as this is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in VTE knowledge between 2 groups
Difference between the knowledge level in the subject group and HCP group after the administration of the educational materials as measured with questionnaire
Measured: 4 weeks
VTE prophylaxis prescription by healthcare providers
Difference in VTE prophylaxis prescribed by HCP after the administration of the educational materials assessed upon patient follow-up/ discharge as reflected by drug prescription sheet and discharge summary
Measured: 4 weeks
VTE prophylaxis adherence
VTE prophylaxis will be advised to subjects upon discharge. Difference in VTE prophylaxis adherence of subjects after the administration of the educational materials will be assessed verbally during follow-up consultation by investigators.
Measured: 4 weeks
Secondary outcomes (3)
Difference in VTE knowledge level within the HCP group
difference in VTE knowledge level within the HCP group before and after the administration of the educational materials as measured with questionnaire.
Measured: 4 weeks
Difference in patient satisfaction
Difference in patient satisfaction scoring before and after the administration of the educational materials to the HCPs assessed during patient follow-up consultation by investigators
Measured: 4 weeks
Difference in the rate of venous thromboembolism (VTE)
Difference in rate of VTE in the HCP group before and after the administration of the educational materials.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start29 Nov 2022
- Primary completion29 Nov 2023
- Study completion4 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GuangMing Tan, Chinese University of Hong Kong
- Investigators
- Bryan Yan, Study chair, Chinese University of Hong KongGuangming Tan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548010
- Sponsor's protocol ID
- VTE
- Status last verified
- Nov 2024
- First submitted
- 16 Sep 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Short Educational Materials in Improving the Knowledge Level of Venous Thromboembolism and the Compliance of Thromboprophylaxis in Post-operative Patients: a Prospective Study
- ClinicalTrials.gov ID
- NCT05548010
- Acronym / sponsor ID
- VTE
- Conditions
- Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 4 Aug 2024 (actual)
- First posted
- 21 Sep 2022 (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.
Venous thromboembolism (VTE) is common especially among post-operative patients, and its occurrence is associated with significant morbidity and mortality. VTE is highly preventable with prophylactic modalities ranging from conservative measures such as early mobilization, to mechanical prophylaxis such as intermittent pneumatic compression (ICP), to pharmacological prophylaxis such as peri-operative anticoagulation. Despite established guidelines from various professional societies, the practice of VTE prophylaxis varied greatly from institute to institute. Evidence suggests that there is a significant gap between the optimal thromboprophylaxis as suggested by experts and real-work practice. Many healthcare-providers (HCP) and patients at risk of VTE are either not aware of the risk of VTE or not confident to apply the necessary thromboprophylaxis. The knowledge level of VTE appears to play a key role in affecting the level of compliance to the optimal thromboprophylaxis. Considerable improvement in VTE prophylaxis utilization may result from the implementation of a multifaceted educational program. By improving patient's awareness on VTE prophylaxis, the incidence of DVT might be reduced. The knowledge level of patients can be improved by various means including educational video, administrative measures, or continue medical education program. However, no prospective study has been performed to assess the impact of an educational program on the VTE knowledge level among post-operative patients and their HCP, and if any improvement of their knowledge level can be translated to a better adherence to VTE prophylaxis guidelines. We therefore propose to conduct a prospective non-randomized controlled study to evaluate the effect of an education materials for the patients as well as their HCP on their knowledge level as well as the utilization and adherence of VTE prophylaxis in these patients by comparing two groups of patients and HCP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Other: No intervention as this is an observational studyPatients >18years old with scheduled operation |
| Healthcare Professionals (HCP) | – | Other: No intervention as this is an observational studyHCP of the enrolled subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The first group will be adult patients age >18 scheduled for surgical operations. The second group will be the HCPs directedly involve in patients care of these surgical patients.
Key inclusion criteria (4 listed)
- Capable of providing written informed consent and willing and able to adhere to all protocol requirements
- Male or female at least 18 years of age at the time of providing written informed consent
- Adult patients age >18 scheduled for surgical operations
- Healthcare Providers directedly involve in patients care of these surgical patients.
Key exclusion criteria (3 listed)
- Unable to make their own informed consent
- Unable to understand the study protocol
- Visually or auditorily impaired.
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 |
|---|---|---|
| No intervention as this is an observational studyNo intervention | Other | Healthcare Professionals (HCP), Subjects |
Primary outcome
Difference in VTE knowledge between 2 groups
Time frame: 4 weeks
Difference between the knowledge level in the subject group and HCP group after the administration of the educational materials as measured with questionnaire
VTE prophylaxis prescription by healthcare providers
Time frame: 4 weeks
Difference in VTE prophylaxis prescribed by HCP after the administration of the educational materials assessed upon patient follow-up/ discharge as reflected by drug prescription sheet and discharge summary
VTE prophylaxis adherence
Time frame: 4 weeks
VTE prophylaxis will be advised to subjects upon discharge. Difference in VTE prophylaxis adherence of subjects after the administration of the educational materials will be assessed verbally during follow-up consultation by investigators.
3 secondary outcomes
Difference in VTE knowledge level within the HCP group
Time frame: 4 weeks
Difference in patient satisfaction
Time frame: 4 weeks
Difference in the rate of venous thromboembolism (VTE)
Time frame: 4 weeks
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 27 Nov 2024.
Related trials for Thromboembolism
RecruitingObservational study
Danang Cerebral Venous Thrombosis Registry
Cerebral Venous Sinus Thrombosis, Stroke
Active, not recruitingObservational study
Epidemiology of Venous Thrombosis and Pulmonary Embolism
Cardiovascular Diseases, Pulmonary Embolism
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism
Not yet recruitingObservational study
TOF-MRV Versus Post-Contrast 3D T1 MRI in Dural Venous Sinus Thrombosis
Cerebral Thrombosis, Venous Thrombosis
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.
Bryan Yan study chair
Chinese University of Hong Kong
Guangming Tan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 3 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 27 Nov 2024. 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 Hong Kong. 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?
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?
Difference in VTE knowledge between 2 groups (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2024.