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

July 28, 2025 updated by: Thomas Curran, Medical University of South Carolina

An Equity Focused Intervention to Improve Utilization of Guideline Concordant Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Thomas Curran, MD MPH
  • Phone Number: 843-876-4846
  • Email: currant@musc.edu

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Curran, MD MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control

For each surgeon cluster this will be the time period prior to initiation of the intervention during which time we will assess contemporary baseline rate of guideline concordant utilization of extended pharmacologic venous thromboembolism prophylaxis.

For patients, this will include survey responses prior to use of dedicated discharge education on venous thromboembolism and prophylaxis strategies.
Experimental: Intervention

For each cluster this will be the time period after initiation of the intervention during which time we will assess the rate of guideline concordant utilization of extended pharmacologic venous thromboembolism prophylaxis with dedicated education and the use of an electronic medical record based clinical decision support system.

For patients, this will include survey responses after use of dedicated discharge education on venous thromboembolism and prophylaxis strategies.
Behavioral: Exposure to clinical decision support system and education

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible patients receiving venous thromboembolism (VTE) prophylaxis prescription; surgeon cluster level analysis
Time Frame: Study duration: 30 months including pre-intervention (range: 6-18 months) and post-intervention (range: 9-21 months)
Proportion of eligible patients receiving prescription for guideline concordant post-discharge VTE prophylaxis.
Study duration: 30 months including pre-intervention (range: 6-18 months) and post-intervention (range: 9-21 months)
Proportion of patients adherent to pharmacologic extended venous thromboembolism prophylaxis (ePpx)
Time Frame: 30 days postoperative
Patient reported via REDCap survey. Adherence will be defined as the percentage of days covered with treatment during the prescription period (i.e. duration at discharge) which has been used previously to assess ePpx. This will include filled prescription and approximate number of doses administered out of number of doses prescribed. Patients without access to electronic mail will be contacted by telephone.
30 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of bleeding events; as extracted from the EMR
Time Frame: 30 and 90 days postoperative
Number of Bleeding events (readmission for bleeding requiring transfusion or reoperation) at the patient level; as extracted from the EMR
30 and 90 days postoperative
Reasons for ePpx missed doses/non-adherence; as reported in patient survey
Time Frame: 30 days postoperative
Patient reported reasons for non-adherence to ePpx reported via patient survey; Choices include: a. I forgot b. Ran out of medicine; too expensive to refill c. Did not have enough help available to give the medicine d. Did not like taking the medicine e. Had a complication (like bleeding) and was instructed to stop taking the medicine f. Was readmitted to the hospital g. Never filled the prescription (free text - why) h. Other (free text)
30 days postoperative
Number of bleeding events; as reported in patient survey
Time Frame: 30 days postoperative
Number of patient reported bleeding events
30 days postoperative
Number of VTE events; as reported in patient survey
Time Frame: 30 days postoperative
Number of patient reported VTE events
30 days postoperative
Number of patients with VTE; as extracted from the electronic medical record (EMR)
Time Frame: 30 and 90 days postoperative
The incidence of VTE at the patient level; as extracted from the EMR
30 and 90 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Thomas Curran, MD MPH, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00130488
  • P30CA138313-15S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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