Non-Interventional Study
OtherNon-interventional study
Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study
NCT Number: NCT07215624
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
San Patricio Medflix, Guaynabo, Puerto Rico
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:
SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:
SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:
SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:
SITE ELIGIBILITY PART 1-SITE ENROLLMENT IN OPEN:
Exclusion criteria
Non-interventional study
Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study
Time frame: After 1 year from start of 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
Self reported utilization as defined above for the primary outcome measure will be reported within strata defined by:
Time frame: After 6 months from start of Part 2
Themes from qualitative interviews by surgeons and APPs
Time frame: After 6 months from start of 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
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network (STOP-VTE)
Acronym: STOP-VTE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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