Education + Decision Support for Blood Clots After Cancer Surgery

Overseen By Brett Bechtol

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Anticoagulants

Disqualifiers: Chronic kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if educating surgeons and patients can prevent blood clots after major cancer surgery. It will assess whether a decision-making tool in medical records (a clinical decision support system) helps surgeons adhere to guidelines for prescribing blood clot prevention medication. Patients will also receive education to see if it improves their understanding and adherence to these medications after discharge. Those who have undergone specific types of cancer surgeries, such as those involving the stomach or kidneys, and have not recently used blood thinners, might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to innovative strategies that could enhance post-surgical care and prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on therapeutic anticoagulation (blood thinners) before or after surgery, you may be excluded from the trial.

What prior data suggests that this protocol is safe for patients after cancer surgery?

Research has shown that using a digital tool to assist doctors in decision-making can reduce the risk of blood clots, known as venous thromboembolism (VTE), after surgery. Heparin, the primary medication for preventing these clots, is generally safe and does not significantly increase the risk of serious bleeding.

Educating patients about the risks of blood clots and prevention strategies is also crucial. By combining this decision-making tool with education, the aim is to enhance how doctors prescribe blood clot prevention medications after major cancer surgery.

These methods have proven safe and effective in lowering the risk of blood clots, offering a promising option for patients recovering from surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how enhancing education and decision support can improve outcomes for patients at risk of blood clots after cancer surgery. Unlike traditional treatments that focus solely on medication, this approach combines patient education with a clinical decision support system integrated into electronic medical records. This method aims to increase adherence to guidelines and improve the use of preventative measures, potentially reducing the risk of complications. By empowering both patients and healthcare providers with better information and support, this trial could lead to more effective management of blood clot risks.

What evidence suggests that this education and decision support system is effective for improving blood clot prevention after cancer surgery?

In this trial, participants will use a computerized clinical decision support system (CDS) and receive education on VTE risk. Research has shown that these measures can significantly reduce the risk of venous thromboembolism (VTE), or blood clots that form in veins after surgery. These systems assist doctors in identifying at-risk patients and recommending preventative medicines, such as heparin, which has been shown to lower the chance of developing these clots without causing major bleeding. Educating patients about the risk of blood clots and the importance of taking prescribed medications can also improve adherence to treatments. Together, these approaches aim to enhance patient safety after surgery by preventing harmful blood clots. ^{1 2 3 4 5}

Who Is on the Research Team?

Thomas Curran, MD MPH

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for patients undergoing major abdominopelvic cancer surgery. It aims to improve the use of blood clot prevention medications after leaving the hospital. Participants should be those who are not currently using these preventive measures effectively.

Inclusion Criteria

My surgeon is part of the MUSC system.

I am having surgery for cancer in my abdomen or pelvis area.

Exclusion Criteria

Lack of survey response

I was not in the hospital for more than 30 days after surgery.

I have been on blood thinners within the last 30 days before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Baseline assessment of guideline concordant utilization of extended pharmacologic venous thromboembolism prophylaxis

6-18 months

Intervention

Implementation of surgeon and patient education interventions, including EMR-based clinical decision support system

9-21 months

Follow-up

Participants are monitored for adherence to prophylaxis and incidence of VTE and bleeding events

30-90 days postoperative

What Are the Treatments Tested in This Trial?

Interventions

• Exposure to clinical decision support system and education

Trial Overview The study tests if surgeon education and a decision support tool in electronic medical records increase proper prescription of blood clot prevention drugs post-surgery. It also examines if patient education at discharge enhances understanding and adherence to these medications.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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.

Group II: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The computerized clinical decision support (CDS) intervention significantly increased the use of recommended VTE prophylaxis from 27.1% to 51.9% across a multi-hospital system, indicating improved adherence to preventive measures against venous thromboembolism.

While the overall VTE rates slightly increased from 2.0% to 2.2%, a focused analysis excluding patients with VTE present on admission showed no change in events, and a surgical subset analysis revealed a reduction in VTE rates from 2.2% to 1.7%, suggesting the CDS intervention effectively enhanced prophylaxis without increasing risk in certain patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a novel and scalable clinical decision support intervention to improve venous thromboembolism prophylaxis: a quasi-experimental study. Umscheid, CA., Hanish, A., Chittams, J., et al.[2021]

The use of electronic reminders significantly increased thromboprophylaxis rates in both admission and transfer wards, with orders rising from 62.4% to 67.7% in admission wards and from 80.2% to 84.3% in transfer wards, indicating improved prevention of venous thromboembolism (VTE).

By delaying prophylaxis checks to 6 hours after patient admission or transfer, the study reduced reminder fatigue by 62%, while still enhancing awareness and compliance with VTE prevention protocols, contributing to safer patient handoffs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of electronic reminders on venous thromboprophylaxis after admissions and transfers. Beeler, PE., Eschmann, E., Schumacher, A., et al.[2022]

Paper-based clinical decision support systems (CDSS) improved venous thromboembolism (VTE) prophylaxis rates, but their impact on actual VTE rates was not clearly established, indicating potential for further improvement.

Computer-based CDSS significantly enhanced the prescribing of appropriate prophylaxis and reduced VTE events, especially in medical patients, suggesting they are more effective than paper-based systems, although some hospitals may lack the necessary technology resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support systems to improve utilization of thromboprophylaxis: a review of the literature and experience with implementation of a computerized physician order entry program. Adams, P., Riggio, JM., Thomson, L., et al.[2012]

Implementing a combination of a computer-based clinical decision support system and training seminars significantly increased the use of appropriate VTE prophylaxis from 46.2% to 57.9% among hospitalized patients, indicating improved adherence to guidelines.

The most notable improvements were seen in high-risk groups, such as cancer patients (from 18.1% to 44.1%) and patients with three or more risk factors (from 25.0% to 42.9%), highlighting the effectiveness of the intervention in protecting those who need it most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical decision support system for venous thromboembolism prophylaxis at a general hospital in a middle-income country. Fuzinatto, F., Waldemar, FS., Wajner, A., et al.[2021]

Implementing computerized clinical decision support systems (CCDSSs) significantly increased the appropriate ordering of venous thromboembolism (VTE) prophylaxis among surgical patients, with an odds ratio of 2.35, indicating more than double the likelihood of proper prophylaxis compared to routine care.

The use of CCDSSs also led to a significant reduction in VTE events, with a risk ratio of 0.78, suggesting that these systems not only improve prophylaxis ordering but also effectively lower the incidence of VTE complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Computerized Clinical Decision Support Systems to Prevent Venous Thromboembolism in Surgical Patients: A Systematic Review and Meta-analysis. Borab, ZM., Lanni, MA., Tecce, MG., et al.[2023]

The implementation of a clinical decision support system (VTE-CDSS) significantly increased the percentage of hospitalized patients assessed for venous thromboembolism (VTE) risk from 77.4% to 93.3% and appropriate VTE prophylaxis from 50.9% to 81.4%.

As a result of the VTE-CDSS, the prevalence of hospital-acquired VTE events was reduced by 50%, demonstrating improved patient safety, although there was no significant change in overall in-hospital mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Computerised Clinical Decision Support on Adherence to VTE Prophylaxis Clinical Practice Guidelines among Hospitalised Patients. Titi, MA., Alotair, HA., Fayed, A., et al.[2021]

The implementation of a computerized clinical decision support tool significantly increased compliance with venous thromboembolism (VTE) prophylaxis guidelines from 66.2% to 84.4% among 1599 hospitalized adult trauma patients.

This improved compliance was linked to a notable reduction in preventable VTE events, decreasing from 1.0% to 0.17%, highlighting the tool's effectiveness in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved prophylaxis and decreased rates of preventable harm with the use of a mandatory computerized clinical decision support tool for prophylaxis for venous thromboembolism in trauma. Haut, ER., Lau, BD., Kraenzlin, FS., et al.[2022]

The electronic clinical decision tool (CDT) for managing anticoagulation in cancer patients with venous thromboembolic (VTE) disease did not significantly change adherence to anticoagulation recommendations compared to pre-intervention practices, with adherence rates of 68.8% before and around 60% after implementation.

Despite no significant change in adherence, the CDT was perceived as helpful and improved the confidence of healthcare providers in managing new VTE cases, indicating its potential value in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a Clinical Decision Tool to Improve Oncologic Venous Thromboembolism Management. Majeed, J., Turner, BS., Kelly, D., et al.[2022]

The implementation of a clinical decision support (CDS) system for venous thromboembolism (VTE) significantly reduced the incidence of VTE, with rates dropping from 0.954 to 0.434 per 1,000 patient days, indicating a 35% lower likelihood of VTE in patients after the CDS was introduced.

The CDS system effectively assessed 78.4% of patients within 24 hours of admission and identified 64.0% at risk for VTE, demonstrating its utility in guiding clinical decisions and improving adherence to VTE prophylaxis guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Clinical Decision Support to Prevent Venous Thromboembolism Among Hospitalized Patients: Proximal Outcomes from a Multiyear Quality Improvement Project. Amland, RC., Dean, BB., Yu, H., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4075831/

A clinical decision support system for venous ... There is considerable evidence that primary prophylaxis with heparin significantly reduces the incidence of VTE without increasing the risk of major bleeding.

2. withpower.com withpower.com/trial/phase-thrombosis-5-2024-4228c

Education + Decision Support for Blood Clots After Cancer ... Research shows that using a computerized clinical decision support system (CDS) can significantly reduce the risk of venous thromboembolism (VTE), which are ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839599

AI-Driven Clinical Decision Support to Reduce Hospital ... This trial protocol describes a randomized clinical trial to assess artificial intelligence (AI)–driven clinical decision support in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06451003

Study Details | NCT06451003 | Intervention to Improve ... An electronic medical record based decision support tool with be initiated that will identify patients who have undergone major abdominopelvic cancer surgery.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X25000770

Clinical outcomes of extended venous thromboembolism ... Most patients who underwent colorectal surgery for cancer did not receive extended VTE prophylaxis. This did not seem to affect the risk of postoperative VTE ...