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

NCT06451003 | Recruiting

• 2 other identifiers: Pro00130488P30CA138313-15S1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism; Pulmonary Embolism; Deep Vein Thrombosis; Cancer; Surgery

Keywords

venous thromboembolism; pulmonary embolism; deep vein thrombosis; cancer; surgery; clinical decision support system

Outcome Measures

Primary Outcomes (2)

• Proportion of eligible patients receiving venous thromboembolism (VTE) prophylaxis prescription; surgeon cluster level analysis

  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)

  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 Outcomes (5)

• Number of patients with VTE; as extracted from the electronic medical record (EMR)

  30 and 90 days postoperative

• Number of bleeding events; as extracted from the EMR

  30 and 90 days postoperative

• Reasons for ePpx missed doses/non-adherence; as reported in patient survey

  30 days postoperative

• Number of bleeding events; as reported in patient survey

  30 days postoperative

• Number of VTE events; as reported in patient survey

  30 days postoperative

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

Exposure to clinical decision support system and education BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (11)

• Panetta CR, Curran T. Extended Venous Thromboembolism Prophylaxis Following Colorectal Cancer Resection. Dis Colon Rectum. 2022 Sep 1;65(9):1079-1082. doi: 10.1097/DCR.0000000000002543. Epub 2022 Jul 15. No abstract available.

  PMID: 35853185 BACKGROUND

• Caprini JA. Risk assessment as a guide for the prevention of the many faces of venous thromboembolism. Am J Surg. 2010 Jan;199(1 Suppl):S3-10. doi: 10.1016/j.amjsurg.2009.10.006.

  PMID: 20103082 BACKGROUND

• Merkow RP, Bilimoria KY, McCarter MD, Cohen ME, Barnett CC, Raval MV, Caprini JA, Gordon HS, Ko CY, Bentrem DJ. Post-discharge venous thromboembolism after cancer surgery: extending the case for extended prophylaxis. Ann Surg. 2011 Jul;254(1):131-7. doi: 10.1097/SLA.0b013e31821b98da.

  PMID: 21527843 BACKGROUND

• Fleming FJ, Kim MJ, Salloum RM, Young KC, Monson JR. How much do we need to worry about venous thromboembolism after hospital discharge? A study of colorectal surgery patients using the National Surgical Quality Improvement Program database. Dis Colon Rectum. 2010 Oct;53(10):1355-60. doi: 10.1007/DCR.0b013e3181eb9b0e.

  PMID: 20847615 BACKGROUND

• Rasmussen MS, Jorgensen LN, Wille-Jorgensen P. Prolonged thromboprophylaxis with low molecular weight heparin for abdominal or pelvic surgery. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD004318. doi: 10.1002/14651858.CD004318.pub2.

  PMID: 19160234 BACKGROUND

• Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. doi: 10.1378/chest.126.3_suppl.338S.

  PMID: 15383478 BACKGROUND

• Khorana AA. The NCCN Clinical Practice Guidelines on Venous Thromboembolic Disease: strategies for improving VTE prophylaxis in hospitalized cancer patients. Oncologist. 2007 Nov;12(11):1361-70. doi: 10.1634/theoncologist.12-11-1361.

  PMID: 18055857 BACKGROUND

• Lyman GH, Khorana AA, Falanga A, Clarke-Pearson D, Flowers C, Jahanzeb M, Kakkar A, Kuderer NM, Levine MN, Liebman H, Mendelson D, Raskob G, Somerfield MR, Thodiyil P, Trent D, Francis CW; American Society of Clinical Oncology. American Society of Clinical Oncology guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer. J Clin Oncol. 2007 Dec 1;25(34):5490-505. doi: 10.1200/JCO.2007.14.1283. Epub 2007 Oct 29.

  PMID: 17968019 BACKGROUND

• Fleming F, Gaertner W, Ternent CA, Finlayson E, Herzig D, Paquette IM, Feingold DL, Steele SR. The American Society of Colon and Rectal Surgeons Clinical Practice Guideline for the Prevention of Venous Thromboembolic Disease in Colorectal Surgery. Dis Colon Rectum. 2018 Jan;61(1):14-20. doi: 10.1097/DCR.0000000000000982. No abstract available.

  PMID: 29219916 BACKGROUND

• Felder S, Rasmussen MS, King R, Sklow B, Kwaan M, Madoff R, Jensen C. Prolonged thromboprophylaxis with low molecular weight heparin for abdominal or pelvic surgery. Cochrane Database Syst Rev. 2019 Aug 26;8(8):CD004318. doi: 10.1002/14651858.CD004318.pub5.

  PMID: 31449321 BACKGROUND

• Borab ZM, Lanni MA, Tecce MG, Pannucci CJ, Fischer JP. Use of Computerized Clinical Decision Support Systems to Prevent Venous Thromboembolism in Surgical Patients: A Systematic Review and Meta-analysis. JAMA Surg. 2017 Jul 1;152(7):638-645. doi: 10.1001/jamasurg.2017.0131.

  PMID: 28297002 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Pulmonary Embolism; Venous Thrombosis; Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Thrombosis

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Thomas Curran, MD MPH

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Curran, MD MPH

CONTACT

843-876-4846; currant@musc.edu

Brett Bechtol

CONTACT

843-792-6659; bechtolb@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Model Details: Stepped wedge randomized controlled trial

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 10, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)