Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

This study evaluates the use of extended venous thromboembolism prophylaxis (ePPx) following abdominopelvic cancer surgery within the NCI Community Oncology Research Program (NCORP) network, targeting surgeons and surgical advanced practice providers (APPs).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

N/A

Trial population

This multi-part study employs a mixed-methods design to evaluate the utilization of ePPx following abdominopelvic cancer surgery within the NCORP network. Part 1 involves a cross-sectional survey of at least 100 surgeons/APPs from at least 25 NCORP sites to evaluate practice patterns related to ePPx. Part 2 utilizes purposive sampling to conduct interviews with 11-25 surgeons/APPs from Part 1 to obtain granular detail about barriers and facilitators to guideline concordant utilization of ePPx. Part 3 will purposively sample 6 practices identified in Part 1 to evaluate the feasibility of EHR queries to assess ePPx utilization.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

  • Non-Interventional Study

    Other intervention

    Non-interventional study

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: Observational Part 11 intervention
Group B: Observational Part 21 intervention
Group C: Observational Part 31 intervention

Trial outcomes

Primary outcomes

1

Self-reported utilization of guideline concordant ePPx for surgeons (Part 1)

Will apply only to surgeons completing the Part 1 survey. Will be defined as answering "Yes, all cases or almost all cases" on the survey question asking about prescription of ePPx after discharge. The proportion of surgeons self-reporting utilization of guideline concordant ePPx will be estimated and reported along with an exact 95% confidence interval.

Time frame
After 1 year from start of Part 1

Secondary outcomes

1

Self-reported utilization of guideline concordant ePPx for surgeons within strata defined by site and surgeon factors (Part 1)

Self reported utilization as defined above for the primary outcome measure will be reported within strata defined by: * Site factors (e.g., proportion of publicly insured patients, proportion of Black patients, presence of a medical school, NCI designation) * Surgeon factors (e.g., fellowship training, years in practice)

Time frame
After 1 year from start of Part 1
2

Barriers and facilitators toward ePPx after cancer surgery, and acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2)

Themes from qualitative interviews by surgeons and APPs

Time frame
After 6 months from start of Part 2
3

Feasibility (i.e., proportion of practices able to provide data) of EHR queries from selected practices to inform future trial (Part 3)

Considered feasible if at least 4 of the 6 practices who agreed to participate are able to provide data on both patients undergoing cancer surgery and prescription of guideline concordant ePPx among eligible patients

Time frame
After 6 months from start of Part 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Cancer Institute (NCI)

Collaborator