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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
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 belowSelect...
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:Select...
I was not in the hospital for more than 30 days after surgery.
Select...
My kidney function is severely reduced.
Select...
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
960 Previous Clinical Trials
7,399,530 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,859 Total Patients Enrolled
3 Trials studying Deep Vein Thrombosis
770 Patients Enrolled for Deep Vein Thrombosis
Thomas Curran, MD MPHPrincipal InvestigatorMedical University of South Carolina
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