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

Wake Forest University Health Sciences500 enrolled

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).

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Malignant Digestive System Neoplasm Malignant Female Reproductive System Neoplasm Malignant Genitourinary System Neoplasm

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Non-Interventional StudyOTHER

Non-interventional study

Non-Interventional StudyOTHER

Non-interventional study

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (28)

Outcomes

Primary Outcomes

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

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

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

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

Central Contacts

Karen Craver

CONTACT

336-716-0891 NCORP@wfusm.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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...and 18 more locations