Intervention to Improve Utilization of Extended Venous Thromboembolism Prophylaxis After Cancer Surgery

Trial Title: Intervention to Improve Utilization of Extended Venous Thromboembolism Prophylaxis After Cancer Surgery

NCT ID: NCT06451003

Condition: Venous Thromboembolism
Pulmonary Embolism
Deep Vein Thrombosis
Cancer
Surgery

Conditions: Official terms:
Pulmonary Embolism
Thrombosis
Embolism
Thromboembolism
Venous Thromboembolism
Venous Thrombosis

Conditions: Keywords:
venous thromboembolism
pulmonary embolism
deep vein thrombosis
cancer
surgery
clinical decision support system

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Stepped wedge randomized controlled trial

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Exposure to clinical decision support system and education
Description: Surgeons will receive education regarding post-discharge venous thromboembolism after cancer surgery. An electronic medical record based decision support tool with be initiated that will identify patients who have undergone major abdominopelvic cancer surgery. The tool will permit use of a risk stratification score and advise guideline concordant post-discharge venous thromboembolism prophylaxis strategies. Patients will receive dedicated venous thromboembolism education at the time of discharge.
Arm group label: Intervention

Summary: While blood clots after major cancer surgery are common and harmful to patients, the medications to decrease blood clot risk are seldom used after patients leave the hospital despite the recommendation of multiple professional medical societies. The reason why these medications are seldom prescribed is not well understood. The main questions this study aims to answer are: - Does surgeon education paired with an electronic medical record based decision support tool improve the guideline concordant prescription of pharmacologic venous thromboembolism after abdominopelvic cancer surgery? - Does dedicated patient education regarding blood clots at the time of hospital discharge after abdominopelvic cancer surgery improve understanding of the risk of venous thromboembolism and adherence to pharmacologic prophylaxis? The investigators will study these questions using a stepped-wedge randomized trial where groups of surgeons will use a tool integrated to the electronic medical record to educate them on the individualized patient risks of blood clots after major cancer surgery and inform them regarding guidelines for preventative medicines. Utilization of the medications before and after using the tool will be compared. Patients will be administered a questionnaire assessing their awareness of blood clots as a risk after cancer surgery. For those prescribed medications to reduce blood clot risk after leaving the hospital, the questionnaire will evaluate whether they took the medications as prescribed. Survey results will be evaluated before and after implementation of education on blood clot risk at the time of hospital discharge.

Detailed description: Specific Aim 1: Conduct a stepped-wedge randomized trial including multi-faceted surgeon focused education and academic detailing to evaluate the impact of an electronic medical record (EMR)-based clinical decision support system (CDSS) to increase adherence to extended pharmacologic venous thromboembolism prophylaxis (ePpx) guidelines at four hospitals (six clinics) within the Medical University of South Carolina (MUSC) Health system. Aim 1. Population. Surgeons performing cancer surgery within the MUSC system will be identified. Patients undergoing surgery for included cancers in the three hospitals will be identified using inclusion/exclusion criteria as follows. "Abdominopelvic cancer surgery" includes esophagectomy, gastrectomy, pancreatectomy, small bowel resection, colectomy, proctectomy, cystectomy, nephrectomy and hysterectomy / oophorectomy performed for a diagnosis of cancer. These surgeons will be the focus of the multi-faceted educational intervention. Aim 1. Intervention. The surgeon focused intervention will involve a combination of: (1) small group education at multi-disciplinary tumor board; (2) on-site/virtual academic detailing performed by the PI; and (3) an EMR-based CDSS. On postoperative day 1, the progress note will incorporate the Caprini model for venous thromboembolism (VTE) risk stratification into the note. The risk stratification will be used to recommend guideline based strategies for ePpx which may be utilized at the discretion of the clinician. A second notification will occur at the time of discharge. Aim 1. Prospective Study Design. The investigators will deploy the intervention described above, including physician education and EMR-based CDSS in a stepped wedge randomized controlled trial (RCT). The five clusters (six clinics) within the four hospitals for randomization include (1) MUSC Florence, (2) MUSC Midlands/Lancaster, and (3) Gastrointestinal, (4) Urologic, and (5) Gynecologic surgical oncology at MUSC Charleston. The investigators propose a prospective, stepped-wedge, cluster RCT with an open cohort design to study the implementation of an EMR-based CDSS. Specific Aim 2: Evaluate the impact of dedicated VTE related pre-discharge education on patient adherence to ePpx via a pre-post study of patients undergoing abdominopelvic cancer surgery at four hospitals within the MUSC Health system. Aim 2. Population and intervention. Patients undergoing the relevant surgical oncology operations at the four sites within the MUSC Enterprise will be the focus of the patient educational intervention. Patients will be identified prospectively using international classification of diseases tenth revision (ICD-10) cancer diagnosis codes matched with the corresponding current procedural terminology (CPT) code. A one-page education sheet will be created to educate patients on the risks of VTE and importance of ePpx. This will be included with the patient's hospital discharge information and reviewed with each patient prior to discharge by the discharge coordinator or nurse. This will be a pre-post study. The pre-intervention period will consist of the six months during which Aim 1 is taking place. The post-intervention will be after the implementation of the educational intervention and last 18 months. The patient population is defined in Aim 1. A REDCap survey will assess adherence to ePpx and health literacy as measured by the validated 3-item Brief Health Literacy Screening, and adverse events.

Criteria for eligibility:
Criteria:
SURGEON CLUSTER Inclusion Criteria: - Surgeons performing cancer surgery within the Medical University of South Carolina (MUSC) system will be identified. Patients undergoing surgery for included cancers in the three hospitals will be identified using inclusion/exclusion criteria as follows. "Abdominopelvic cancer surgery" includes esophagectomy, gastrectomy, pancreatectomy, small bowel resection, colectomy, proctectomy, cystectomy, nephrectomy and hysterectomy / oophorectomy performed for a diagnosis of cancer as identified by Current Procedural Terminology (CPT) code and International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code. Exclusion Criteria: - We will exclude patients receiving preoperative therapeutic anticoagulation within 30 days preoperatively, patients initiating therapeutic anticoagulation postoperatively and patients with chronic kidney disease grade 3 or higher. Patients with postoperative length of stay 30 days or greater will be excluded as ePpx duration is for 30 days postoperative. PATIENT SURVEY Inclusion Criteria: - Patients undergoing surgery for included cancers in the three hospitals will be identified using inclusion/exclusion criteria as follows. "Abdominopelvic cancer surgery" includes esophagectomy, gastrectomy, pancreatectomy, small bowel resection, colectomy, proctectomy, cystectomy, nephrectomy and hysterectomy / oophorectomy performed for a diagnosis of cancer as identified by Current Procedural Terminology (CPT) code and International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code. Exclusion Criteria: - We will exclude patients receiving preoperative therapeutic anticoagulation within 30 days preoperatively, patients initiating therapeutic anticoagulation postoperatively and patients with chronic kidney disease grade 3 or higher. Patients with postoperative length of stay 30 days or greater will be excluded as extended pharmacologic venous thromboembolism duration is for 30 days postoperative. - Lack of survey response.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Medical University of South Carolina

Address:
City: Charleston
Zip: 29425
Country: United States

Status: Recruiting

Contact:
Last name: Thomas Curran, MD MPH

Phone: 843-876-4846
Email: currant@musc.edu

Contact backup:
Last name: Brett Bechtol

Phone: 843-792-6659
Email: bechtolb@musc.edu

Investigator:
Last name: Thomas Curran, MD MPH
Email: Principal Investigator

Start date: July 1, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Medical University of South Carolina
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Medical University of South Carolina

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06451003