- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07292376
Implementing VTE Prevention in Ambulatory Cancer Care
assess effectiveness of a , compared with usual care, to assess
The goal of this study is to learn if a modified clinical program can improve adherence to guideline recommendations for prevention of venous thromboembolism in ambulatory patients with cancer. The main question[s] it aims to answer are:
Does the modified program improve number of ambulatory oncology patients starting systemic treatment getting VTE risk-assessment? Does the modified program improve the number of patients receiving appropriate preventative anticoagulation? Researchers will compare to usual care (no clinical program).
Participant clinicians will be asked to
- receive education about VTE prevention recommendations
- carry out risk assessment, anticoagulation discussions, and document the results Participant patients will receive care from clinicians participating in the study as part of their cancer care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vermont
-
Burlington, Vermont, United States, 05405
- Vermont Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinicians: practicing oncologist at study clinic site (UVMMC)
- Patients: diagnosis of cancer; starting new systemic cancer-directed therapy at a study clinic site under the direction of the enrolled clinician
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Clinical program
|
Revised Vermont Model clinical program, including standardized education and training for oncology care team, clinical decision support and revised workflow for VTE risk assessment and thromboprophylaxis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Documented VTE risk assessment
Time Frame: 30 days after new patient appointment
|
Proportion of new patients who have documented VTE risk assessment
|
30 days after new patient appointment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appropriate thromboprophylaxis
Time Frame: 30 days after new patient appointment
|
Proportion of identified high-risk patients with prescription for thromboprophylaxis and low-risk patients without thromboprophylaxis
|
30 days after new patient appointment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karlyn Martin, MD, University of Vermont
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP00005110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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