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}

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical University of South Carolina Charleston, SC

Who Is Running the Clinical Trial?

Medical University of South Carolina Lead Sponsor

National Cancer Institute (NCI) Collaborator

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] Venous thromboembolism (VTE) causes morbidity and mortality in hospitalized patients, and regulators and payors are encouraging the use of systems to prevent them. Here, we examine the effect of a computerized clinical decision support (CDS) intervention implemented across a multi-hospital academic health system on VTE prophylaxis and events.

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] Despite venous thromboembolism (VTE) policy initiatives, gaps exist between guidelines and practice. In response, hospitals implement clinical decision support (CDS) systems to improve VTE prophylaxis. To assess the impact of a VTE CDS on reducing incidence of VTE, this study used a pretest/posttest, longitudinal, cohort design incorporating electronic health record (EHR) data from one urban tertiary and level 1 trauma center, and one suburban hospital. VTE CDS was embedded into the EHR system. The study included 45,046 admissions; 171,753 patient days; and 110 VTE events. The VTE rate declined from 0.954 per 1,000 patient days to 0.434 comparing baseline to full VTE CDS. Compared to baseline, patients benefitting from VTE CDS were 35% less likely to have a VTE. VTE CDS utilization achieved 78.4% patients assessed within 24 hr from admission, 64.0% patients identified at risk, and 47.7% patients at risk for VTE with an initiated VTE interdisciplinary plan of care. CDS systems with embedded algorithms, alerts, and notification capabilities enable physicians at the point of care to utilize guidelines and make impactful decisions to prevent VTE. This study demonstrates a phased-in implementation of VTE CDS as an effective approach toward VTE prevention. Implications for future research and quality improvement are discussed as well.

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] To determine the impact that implementing a combination of a computer-based clinical decision support system and a program of training seminars has on the use of appropriate prophylaxis for venous thromboembolism (VTE).

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] A literature review was conducted of studies investigating the effectiveness of paper- and computer-based clinical decision support systems (CDSS) used with or without educational programs designed to increase the use of venous thromboembolism (VTE) prophylaxis.

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] Venous thromboembolism is associated with substantial morbidity and mortality and is largely preventable. Despite this fact, appropriate prophylaxis is vastly underutilized. To improve compliance with best practice prophylaxis for VTE in hospitalized trauma patients, we implemented a mandatory computerized provider order entry-based clinical decision support tool. The system required completion of checklists of VTE risk factors and contraindications to pharmacologic prophylaxis. With this tool, we were able to determine a patient's risk stratification level and recommend appropriate prophylaxis. To evaluate the effect of our mandatory computerized provider order entry-based clinical decision support tool on compliance with prophylaxis guidelines for venous thromboembolism (VTE) and VTE outcomes among admitted adult trauma patients.

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] Venous thromboembolism (VTE) is an important patient safety concern. VTE leads to significant mortality and morbidity and a burden on healthcare resources. Despite the widespread availability of evidence-based clinical practice guidelines on VTE prophylaxis, we found that only 50.9% of our patients were receiving appropriate prophylaxis. The purpose of this study was to evaluate the impact of automation of an adapted VTE prophylaxis CPG using a clinical decision support system (the VTE-CDSS) on VTE prevention among hospitalised adult patients.

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

Impact of electronic reminders on venous thromboprophylaxis after admissions and transfers. [2022] Clinical decision support has the potential to improve prevention of venous thromboembolism (VTE). The purpose of this prospective study was to analyze the effect of electronic reminders on thromboprophylaxis rates in wards to which patients were admitted and transferred. The latter was of particular interest since patient handoffs are considered to be critical safety issues.

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] Health care professionals do not adequately stratify risk or provide prophylaxis for venous thromboembolism (VTE) among surgical patients. Computerized clinical decision support systems (CCDSSs) have been implemented to assist clinicians and improve prophylaxis for VTE.

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

Implementing a Clinical Decision Tool to Improve Oncologic Venous Thromboembolism Management. [2022] Cancer patients with venous thromboembolic (VTE) disease are complex, and many factors must be considered when initiating anticoagulation management. Clinical decision support systems can aid in decision-making by utilizing guidelines at the point of care.