Venous Thromboembolism (VTE) Knowledge

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: Completed
• Conditions: Thromboembolism
• Intervention / Treatment: Other: No intervention as this is an observational study

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	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	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	4 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Study Chair: Bryan Yan, Chinese University of Hong Kong; Principal Investigator: GuangMing Tan, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): August 4, 2024

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID 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