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

Official title

Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network (STOP-VTE)

Overview

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).

Detailed description

PRIMARY OBJECTIVE:

I. To evaluate self-reported utilization of guideline concordant extended venous thromboembolism (VTE) prophylaxis (ePPx) following abdominopelvic cancer surgery within a sample of surgeons practicing within NCORP based on the Part 1 surgeon survey.

SECONDARY OBJECTIVES:

I. Evaluate site factors (e.g., proportion of publicly insured patients, proportion of Black patients, presence of a medical school, NCI designation) and surgeon factors (e.g., fellowship training, years in practice) associated with surgeon self-reported guideline concordant ePPx utilization (Part 1).

II. Conduct semi-structured interviews among a subset of surgeons and surgical APPs to assess: 1) Barriers/facilitators toward ePPx after cancer surgery and 2) Acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2).

III. Extract EHR data from select practices to assess the feasibility of query-based electronic health record (EHR) data extraction for identification of (i) patients undergoing cancer surgery, and (ii) prescription of guideline concordant ePPx among eligible patients (Part 3).

OUTLINE: This is an observational study.

PART 1: Surgeons and APPs complete a survey on study. After completion of surgeon or APP survey, site contact person or Cancer Care Delivery Research (CCDR) lead complete site surveys on study.

PART 2: A subset of surgeons and APPs from part 1 complete a semi-structured interview on study.

PART 3: Site contact person or CCDR lead complete a survey to identify a EHR Report Specialist on study. EHR Report Specialist performs an EHR Data Extraction and provides feedback on the process in a survey.

Interventions

• Other Non-Interventional Study
  Non-interventional study
• Other Non-Interventional Study
  Non-interventional study
• Other Non-Interventional Study
  Non-interventional study

Primary outcome measures

• Self-reported utilization of guideline concordant ePPx for surgeons (Part 1) [Time frame: After 1 year from start of Part 1]

Secondary outcome measures (3)

• Self-reported utilization of guideline concordant ePPx for surgeons within strata defined by site and surgeon factors (Part 1) [Time frame: After 1 year from start of Part 1]
• Barriers and facilitators toward ePPx after cancer surgery, and acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2) [Time frame: After 6 months from start of Part 2]
• Feasibility (i.e., proportion of practices able to provide data) of EHR queries from selected practices to inform future trial (Part 3) [Time frame: After 6 months from start of Part 3]

Eligibility criteria

Inclusion criteria

SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:

\* Any surgeon performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgeons do not need to be involved in research or have a Cancer Therapy Evaluation Program Identification (CTEP ID) to participate in this study

SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:

\* APPs providing postoperative care to patients operated by surgeons performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgical APPs do not need to be involved in research or have a CTEP ID to participate in this study

SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:

\* Must have completed the STOP-VTE Survey - Surgeon electronically (preferred) or on paper and have it transferred to Research Electronic Data Capture (REDCap) by the contact person(s)

SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:

\* Must have completed the STOP-VTE Survey - APP electronically (preferred) or on paper and have it transferred to REDCap by the contact person(s)

SITE ELIGIBILITY PART 1-SITE ENROLLMENT IN OPEN:

\* Have at least one eligible surgeon or surgical APP who completed the STOP-VTE Survey - Surgeon/APP

Exclusion criteria

• N/A

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

United States · 58 centers

• Mercy Hospital Fort Smith — Fort Smith
• Helen F Graham Cancer Center — Newark
• Medical Oncology Hematology Consultants PA — Newark
• Christiana Care Health System-Christiana Hospital — Newark
• Northside Hospital — Atlanta
• Augusta University Medical Center — Augusta
• Northside Hospital - Gwinnett — Lawrenceville
• Carle Cancer Center — Urbana
• … and 50 more centers

Puerto Rico · 1 center

• San Patricio Medflix — Guaynabo

Identifiers

NCT: NCT07215624 · IRB00138219 · NCI-2025-06376 · WF-2502CD · WF-2502CD · WF-2502CD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗