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Education + Decision Support for Blood Clots After Cancer Surgery

N/A

Recruiting

Led By Thomas Curran, MD MPH

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Patients with postoperative length of stay 30 days or greater will be excluded as ePpx duration is for 30 days postoperative

Patients with chronic kidney disease grade 3 or higher

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study duration: 30 months including pre-intervention (range: 6-18 months) and post-intervention (range: 9-21 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand why medications to reduce blood clot risk are not often prescribed to cancer surgery patients after they leave the hospital. The study will investigate if educating surgeons and patients about blood clot risks will

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves educational components rather than direct medical treatments, there are no direct side effects from medication or procedures being tested within this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My kidney function is severely reduced.

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I started blood thinners after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study duration: 30 months including pre-intervention (range: 6-18 months) and post-intervention (range: 9-21 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study duration: 30 months including pre-intervention (range: 6-18 months) and post-intervention (range: 9-21 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and study duration: 30 months including pre-intervention (range: 6-18 months) and post-intervention (range: 9-21 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Proportion of patients adherent to pharmacologic extended venous thromboembolism prophylaxis (ePpx)

Secondary study objectives

Number of VTE events; as reported in patient survey

Number of bleeding events; as extracted from the EMR

Number of bleeding events; as reported in patient survey

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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: ControlActive Control1 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.

0 / 4Eligibility criteria met