Venous Thromboembolism (VTE) Knowledge

Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548010
• Other study ID #: VTE
• Status: Recruiting
• Start date: November 29, 2022
• Est. completion date: November 29, 2023

Study information

• Verified date: March 2023
• Source: Chinese University of Hong Kong
• Contact: Daniel Xu
• Phone: 35051518
• Email: danielxu[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• No intervention as this is an observational study
No intervention

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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