Intervention to Improve Utilization of Extended Venous Thromboembolism Prophylaxis After Cancer Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Surgeons performing cancer surgery within the Medical University of South Carolina (MUSC) system will be identified. Patients undergoing surgery for included cancers in the three hospitals will be identified using inclusion/
Disqualifiers
We will exclude patients receiving preoperative therapeutic anticoagulation within 30 days preoperatively, patients initiating therapeutic anticoagulation postoperatively and patients with chronic kidney disease grade 3 or higher. Patients with postoperative length of stay 30 days or greater will be excluded as ePpx duration is for 30 days postoperative.
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.
We will exclude patients receiving preoperative therapeutic anticoagulation within 30 days preoperatively, patients initiating therapeutic anticoagulation postoperatively and patients with chronic kidney disease grade 3 or higher. Patients with postoperative length of stay 30 days or greater will be excluded as extended pharmacologic venous thromboembolism duration is for 30 days postoperative.
Lack of survey response.
Trial design
Design model
Parallel
Treatments tested in this trial
Exposure to clinical decision support system and education
BehavioralSurgeons will receive education regarding post-discharge venous thromboembolism after cancer surgery. An electronic medical record based decision support tool with be initiated that will identify patients who have undergone major abdominopelvic cancer surgery. The tool will permit use of a risk stratification score and advise guideline concordant post-discharge venous thromboembolism prophylaxis strategies. Patients will receive dedicated venous thromboembolism education at the time of discharge.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of eligible patients receiving venous thromboembolism (VTE) prophylaxis prescription; surgeon cluster level analysis
Proportion of eligible patients receiving prescription for guideline concordant post-discharge VTE prophylaxis.
Time frame
Study duration: 30 months including pre-intervention (range: 6-18 months) and post-intervention (range: 9-21 months)2
Proportion of patients adherent to pharmacologic extended venous thromboembolism prophylaxis (ePpx)
Patient reported via REDCap survey. Adherence will be defined as the percentage of days covered with treatment during the prescription period (i.e. duration at discharge) which has been used previously to assess ePpx. This will include filled prescription and approximate number of doses administered out of number of doses prescribed. Patients without access to electronic mail will be contacted by telephone.
Time frame
30 days postoperativeSecondary outcomes
1
Number of patients with VTE; as extracted from the electronic medical record (EMR)
The incidence of VTE at the patient level; as extracted from the EMR
Time frame
30 and 90 days postoperative2
Number of bleeding events; as extracted from the EMR
Number of Bleeding events (readmission for bleeding requiring transfusion or reoperation) at the patient level; as extracted from the EMR
Time frame
30 and 90 days postoperative3
Reasons for ePpx missed doses/non-adherence; as reported in patient survey
Patient reported reasons for non-adherence to ePpx reported via patient survey; Choices include: a. I forgot b. Ran out of medicine; too expensive to refill c. Did not have enough help available to give the medicine d. Did not like taking the medicine e. Had a complication (like bleeding) and was instructed to stop taking the medicine f. Was readmitted to the hospital g. Never filled the prescription (free text - why) h. Other (free text)
Time frame
30 days postoperative4
Number of bleeding events; as reported in patient survey
Number of patient reported bleeding events
Time frame
30 days postoperativeSponsors and contacts
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Medical University of South Carolina
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov