An Equity Focused Intervention to Improve Utilization of Guideline Concordant Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Proportion of eligible patients receiving venous thromboembolism (VTE) prophylaxis prescription; surgeon cluster level analysis
研究概览
简要总结
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.
详细描述
Specific Aim 1: 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 clinical decision support system (CDSS) to increase adherence to extended pharmacologic venous thromboembolism prophylaxis (ePpx) guidelines at four hospitals (six clinics) within the Medical University of South Carolina (MUSC) Health system.
Aim 1. Population. Surgeons performing cancer surgery within the MUSC system will be identified. 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. These surgeons will be the focus of the multi-faceted educational intervention.
Aim 1. Intervention. The surgeon focused intervention will involve a combination of: (1) small group education at multi-disciplinary tumor board; (2) on-site/virtual academic detailing performed by the PI; and (3) an EMR-based CDSS. On postoperative day 1, the progress note will incorporate the Caprini model for venous thromboembolism (VTE) risk stratification into the note. The risk stratification will be used to recommend guideline based strategies for ePpx which may be utilized at the discretion of the clinician. A second notification will occur at the time of discharge.
Aim 1. Prospective Study Design. The investigators will deploy the intervention described above, including physician education and EMR-based CDSS in a stepped wedge randomized controlled trial (RCT). The five clusters (six clinics) within the four hospitals for randomization include (1) MUSC Florence, (2) MUSC Midlands/Lancaster, and (3) Gastrointestinal, (4) Urologic, and (5) Gynecologic surgical oncology at MUSC Charleston. The investigators propose a prospective, stepped-wedge, cluster RCT with an open cohort design to study the implementation of an EMR-based CDSS.
Specific Aim 2: Evaluate the impact of dedicated VTE related pre-discharge education on patient adherence to ePpx via a pre-post study of patients undergoing abdominopelvic cancer surgery at four hospitals within the MUSC Health system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SURGEON CLUSTER
- •Inclusion Criteria:
- •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/
排除标准
- •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.
- •Exclusion Criteria:
- •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.
- •PATIENT SURVEY
- •Inclusion Criteria:
- •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.
- •Exclusion Criteria:
- •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.
研究组 & 干预措施
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.
干预措施: Exposure to clinical decision support system and education (Behavioral)
Control
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.
结局指标
主要结局
Proportion of eligible patients receiving venous thromboembolism (VTE) prophylaxis prescription; surgeon cluster level analysis
时间窗: Study duration: 30 months including pre-intervention (range: 6-18 months) and post-intervention (range: 9-21 months)
Proportion of eligible patients receiving prescription for guideline concordant post-discharge VTE prophylaxis.
Proportion of patients adherent to pharmacologic extended venous thromboembolism prophylaxis (ePpx)
时间窗: 30 days postoperative
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.
次要结局
- Number of bleeding events; as extracted from the EMR(30 and 90 days postoperative)
- Number of patients with VTE; as extracted from the electronic medical record (EMR)(30 and 90 days postoperative)
- Number of VTE events; as reported in patient survey(30 days postoperative)
- Reasons for ePpx missed doses/non-adherence; as reported in patient survey(30 days postoperative)
- Number of bleeding events; as reported in patient survey(30 days postoperative)
研究者
Thomas Curran
Associate Professor-Faculty
Medical University of South Carolina