Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451003
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-17
Brief Title:
Intervention to Improve Utilization of Extended Venous Thromboembolism Prophylaxis After Cancer Surgery
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
An Equity Focused Intervention to Improve Utilization of Guideline Concordant Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 inclusionexclusion 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-sitevirtual 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 MidlandsLancaster 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
Aim 2 Population and intervention Patients undergoing the relevant surgical oncology operations at the four sites within the MUSC Enterprise will be the focus of the patient educational intervention Patients will be identified prospectively using international classification of diseases tenth revision ICD-10 cancer diagnosis codes matched with the corresponding current procedural terminology CPT code A one-page education sheet will be created to educate patients on the risks of VTE and importance of ePpx This will be included with the patients hospital discharge information and reviewed with each patient prior to discharge by the discharge coordinator or nurse This will be a pre-post study The pre-intervention period will consist of the six months during which Aim 1 is taking place The post-intervention will be after the implementation of the educational intervention and last 18 months The patient population is defined in Aim 1 A REDCap survey will assess adherence to ePpx and health literacy as measured by the validated 3-item Brief Health Literacy Screening and adverse events
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 inclusionexclusion 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-sitevirtual 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 MidlandsLancaster 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
Aim 2 Population and intervention Patients undergoing the relevant surgical oncology operations at the four sites within the MUSC Enterprise will be the focus of the patient educational intervention Patients will be identified prospectively using international classification of diseases tenth revision ICD-10 cancer diagnosis codes matched with the corresponding current procedural terminology CPT code A one-page education sheet will be created to educate patients on the risks of VTE and importance of ePpx This will be included with the patients hospital discharge information and reviewed with each patient prior to discharge by the discharge coordinator or nurse This will be a pre-post study The pre-intervention period will consist of the six months during which Aim 1 is taking place The post-intervention will be after the implementation of the educational intervention and last 18 months The patient population is defined in Aim 1 A REDCap survey will assess adherence to ePpx and health literacy as measured by the validated 3-item Brief Health Literacy Screening and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA138313-15S1 | NIH | None | httpsreporternihgovquickSearchP30CA138313-15S1 |