Education + Decision Support for Blood Clots After Cancer Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Thomas Curran, MD MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical University of South Carolina

Must not be taking: Anticoagulants

Disqualifiers: Chronic kidney disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for preventing blood clots after cancer surgery?

Research shows that using a computerized clinical decision support system (CDS) can significantly reduce the risk of venous thromboembolism (VTE), which are dangerous blood clots, in hospitalized patients. In one study, the use of a CDS system led to a 35% reduction in VTE events, demonstrating its effectiveness in improving patient outcomes. ^{1 2 3 4 5}

Is the clinical decision support system and education for VTE prophylaxis safe for humans?

The studies reviewed focus on the effectiveness of clinical decision support systems in preventing blood clots after surgery, but they do not report any safety concerns for humans using these systems. ^{2 4 6 7 8}

How does the treatment for blood clots after cancer surgery differ from other treatments?

This treatment is unique because it combines education and decision support systems to help manage blood clots after cancer surgery. Unlike traditional treatments that focus solely on medication, this approach uses clinical decision support tools to guide healthcare providers in making informed decisions, potentially improving adherence to guidelines and reducing the incidence of blood clots. ^{2 4 6 7 9}

Research Team

Thomas Curran, MD MPH

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Exposure to clinical decision support system and education (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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 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]

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]

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]

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 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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a novel and scalable clinical decision support intervention to improve venous thromboembolism prophylaxis: a quasi-experimental study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Computerized Clinical Decision Support to Prevent Venous Thromboembolism Among Hospitalized Patients: Proximal Outcomes from a Multiyear Quality Improvement Project. [2018]

3. Brazil pubmed.ncbi.nlm.nih.gov

A clinical decision support system for venous thromboembolism prophylaxis at a general hospital in a middle-income country. [2021]

4. England 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. [2012]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effects of Computerised Clinical Decision Support on Adherence to VTE Prophylaxis Clinical Practice Guidelines among Hospitalised Patients. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Impact of electronic reminders on venous thromboprophylaxis after admissions and transfers. [2022]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Implementing a Clinical Decision Tool to Improve Oncologic Venous Thromboembolism Management. [2022]