This clinical trial studies how well a multi-faceted intervention works in improving utilization of guidelines for extended venous thromboembolism (VTE) prevention (prophylaxis) after major surgery for cancer of the abdomen or pelvis (abdominopelvic). VTE is a condition that occurs when a blood clot forms in a vein, and is a leading cause of death after major cancer surgery. Extended VTE prophylaxis (ePpx) has been shown to be safe and effective, and is recommended after abdominopelvic cancer surgery using low molecular weight heparin (LMWH). LMWH works by stopping the formation of substances that cause clots. However, adherence to ePpx remains low. Computerized clinical decision support systems (CDSS) have been deployed in a variety of clinical contexts to improve healthcare quality. CDSS has been shown to improve inpatient VTE prophylaxis utilization, but this approach has not been applied to ePpx post-hospital discharge. A multi-faceted intervention that uses a CDSS and surgeon and patient education may be effective in improving utilization of ePpx guidelines after major abdominopelvic surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06451003.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Thomas Curran
Phone: 843-876-4846
PRIMARY OBJECTIVES:
I. Conduct a stepped-wedge randomized trial including multi-faceted surgeon-focused education and academic detailing to evaluate the impact of an electronic medical record (EMR)-based CDSS to increase adherence to ePpx guidelines at the three selected hospitals.
II. Evaluate the impact of VTE related pre-discharge education on patient adherence to ePpx via a pre-post study of patients undergoing abdominopelvic cancer surgery at the three selected hospitals.
OUTLINE: Medical University of South Carolina (MUSC) clinics are randomized to 1 of 5 arms.
ARM I: Surgeons performing cancer surgery at MUSC clinics randomized to this arm perform usual care during the control phase of the trial (months 1-6), followed by a transition phase (months 7-9). Beginning in month 10 and continuing to month 30, surgeons receive an educational intervention over 1 month that involves a combination of: 1) small group education at multidisciplinary tumor board; 2) on-site academic detailing performed by the principal investigator (PI); and 3) an EMR-based CDSS. Patients receiving care from surgeons randomized to this arm receive a one-page educational sheet at the time of hospital discharge.
ARM II: Surgeons performing cancer surgery at MUSC clinics randomized to this arm perform usual care during the control phase of the trial (months 1-9), followed by a transition phase (months 10-12). Beginning in month 13 and continuing to month 30, surgeons receive an educational intervention over 1 month that involves a combination of: 1) small group education at multidisciplinary tumor board; 2) on-site academic detailing performed by the PI; and 3) an EMR-based CDSS. Patients receiving care from surgeons randomized to this arm receive a one-page educational sheet at the time of hospital discharge.
ARM III: Surgeons performing cancer surgery at MUSC clinics randomized to this arm perform usual care during the control phase of the trial (months 1-12), followed by a transition phase (months 13-15). Beginning in month 16 and continuing to month 30, surgeons receive an educational intervention over 1 month that involves a combination of: 1) small group education at multidisciplinary tumor board; 2) on-site academic detailing performed by the PI; and 3) an EMR-based CDSS. Patients receiving care from surgeons randomized to this arm receive a one-page educational sheet at the time of hospital discharge.
ARM IV: Surgeons performing cancer surgery at MUSC clinics randomized to this arm perform usual care during the control phase of the trial (months 1-15), followed by a transition phase (months 16-18). Beginning in month 19 and continuing to month 30, surgeons receive an educational intervention over 1 month that involves a combination of: 1) small group education at multidisciplinary tumor board; 2) on-site academic detailing performed by the PI; and 3) an EMR-based CDSS. Patients receiving care from surgeons randomized to this arm receive a one-page educational sheet at the time of hospital discharge.
ARM V: Surgeons performing cancer surgery at MUSC clinics randomized to this arm perform usual care during the control phase of the trial (months 1-18), followed by a transition phase (months 19-21). Beginning in month 22 and continuing to month 30, surgeons receive an educational intervention over 1 month that involves a combination of: 1) small group education at multidisciplinary tumor board; 2) on-site academic detailing performed by the PI; and 3) an EMR-based CDSS. Patients receiving care from surgeons randomized to this arm receive a one-page educational sheet at the time of hospital discharge.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationMedical University of South Carolina
Principal InvestigatorThomas Curran
