About the Study
How old do patients have to be for study inclusion?
Patients must be between 10 and 18 years of age to be included in this study.
What types of procedures are included in this study?
Elective GI surgeries, including bowel resection, ileostomy and colostomy reversals, ileocecectomy, J pouch creation, and total colectomy, among many others. Procedures that are excluded are: exclusive perianal disease and emergent procedures.
We are transitioning from Cerner to Epic, are there any problems with this?
No, there are no issues with any EMR you use, as long as the data abstractors know where to find the elements.
What is the time estimate for data collection?
We estimate 10 hours per patient, including pre-operative work. As the data abstractor gets use to collecting data, then it will become more efficient.
Can a data abstractor be used even if they are only available for a short period of time?
Absolutely. Our team will be able to catch any person up in short order and get access to REDCap to start collecting right away. There is a Data Dictionary to help the data abstractor find elements in the EMR. We will also be recording our REDCap webinars. If you anticipate having multiple abstractors, keep the DCC updated so we can help onboard the abstractors.
Does the PI need to register with Advarra?
Each site’s PI needs to register on www.cirbi.net , as well as any staff who will be working with the IRB. Once the PI has registered, then the site application can be submitted.
What’s the point of the single IRB and informed consent?
The use of a single IRB of record for multi-site studies conducting the same protocol will help streamline the IRB review process and remove redundant hurdles to the initiation of such studies. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects’ protections. We need the patient’s permission to collect personal health information from their medical record, and to complete 3 surveys.
Where can I find the protocol and master ICFs?
The protocol and all three consent forms will be accessible under the provider login.
Are small bowel procedures included? What should we do about bowel prep?
Yes, small bowel procedures can be included in the study. However, we are not including foregut and perianal procedures. You should continue to use whatever institutional practices you currently use regarding bowel prep, as there are many other aspects of enhanced recovery protocols (ERPs) that would benefit the patients that are not related to bowel prep. We’re hoping to learn which ERPs are most important in this study.
What happens when there’s turnover of staff?
Let us know right away, and we’ll walk you through the steps to onboard the new team member.
What about sites already implementing ERPs?
This is a pragmatic, real world study. We anticipate that there will be some aspects of the ERPs that sites are struggling with, and they will learn new information during the intervention phase. And if you are performing some elements well, you have the opportunity to coach the other hospitals within your Learning Collaborative.
Is there information on Return on Investment (RoI)?
Find information on Return on Investment for ERAS programs here.
Any other questions? Contact us at email@example.com
If a patient has multiple GI surgeries planned, can the patient be enrolled in ENRICH-US for each surgery?
Yes. One patient can be enrolled in ENRICH-US multiple times, as long as they continue to meet the inclusion criteria. Each operative date represents a distinct opportunity to enroll the patient and their family in the study.