Venous Thromboembolism (VTE) Knowledge

November 26, 2024 updated by: GuangMing Tan, Chinese University of Hong Kong

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong, 999077
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion criteria

  • Unable to make their own informed consent
  • Unable to understand the study protocol
  • Visually or auditorily impaired.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Subjects
Patients >18years old with scheduled operation
Other: No intervention as this is an observational study
No intervention
Healthcare Professionals (HCP)
HCP of the enrolled subjects
Other: No intervention as this is an observational study
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 weeks
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
4 weeks
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in VTE knowledge level within the HCP group
Time Frame: 4 weeks
difference in VTE knowledge level within the HCP group before and after the administration of the educational materials as measured with questionnaire.
4 weeks
Difference in patient satisfaction
Time Frame: 4 weeks
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
4 weeks
Difference in the rate of venous thromboembolism (VTE)
Time Frame: 4 weeks
Difference in rate of VTE in the HCP group before and after the administration of the educational materials.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bryan Yan, Chinese University of Hong Kong
  • Principal Investigator: GuangMing Tan, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VTE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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