NCT05548010

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 29, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

September 16, 2022

Last Update Submit

November 26, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Difference in VTE knowledge level within the HCP group

    4 weeks

  • Difference in patient satisfaction

    4 weeks

  • Difference in the rate of venous thromboembolism (VTE)

    4 weeks

Study Arms (2)

Subjects

Patients \>18years old with scheduled operation

Other: No intervention as this is an observational study

Healthcare Professionals (HCP)

HCP of the enrolled subjects

Other: No intervention as this is an observational study

Interventions

No intervention

Healthcare Professionals (HCP)Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 999077, Hong Kong

Location

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Bryan Yan

    Chinese University of Hong Kong

    STUDY CHAIR
  • Guangming Tan

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

November 29, 2022

Primary Completion

November 29, 2023

Study Completion

August 4, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations