Sites can enroll for the PROMPT Study efficiently and securely. The enrollment process includes several key steps.
Sites must complete the PROMPT Study Enrollment Form as the initial step to participate in the PROMPT Study. The initial enrollment form will take 1-2 minutes to complete. Once the enrollment form is received by ArborMetrix, you will receive a welcome email and further instructions regarding next steps, including an additional page of requested information regarding key personnel and site details that will help streamline the onboarding process. Here is a sample of the additional information we will need.
The goal of the site discovery questionnaire is to gather important information regarding your site’s EHR system setup and make certain we can gather the necessary data elements from you via an automated data feed from your EHR system directly into the PROMPT Study via the PACE Registry. Once you have completed the site discovery questionnaire, a data integration specialist from ArborMetrix will reach out to schedule a meeting with key personnel from your site, including your EHR Vendor contact, IT Support Staff, and the Project Lead.
Prior to submitting any data to the PACE Registry for the PROMPT Study, sites must complete the required legal documents:
ArborMetrix is using Advarra to facilitate a Centralized IRB for the PROMPT Study. ArborMetrix will provide the sites with a copy of the exemption ruling from the IRB. Sites will not need to apply for a localized IRB. They can simply enroll to participate and submit data directly to the PACE Registry.
Once a site has completed the enrollment documentation, site discovery questionnaire and executed their legal contracts, they can begin the process for data submission. A data integration specialist from ArborMetrix will have already reached out to the program lead at your site to discuss the results of your Site Discovery Questionnaire and answered any further questions. At this point, the site will need to review the following to better understand the data transmission specifications:
ArborMetrix will set up a time to meet with the program lead, EHR vendor, and internal IT support (if applicable) to answer any questions the site has and begin the process of setting up the site for data transfer.
The data specification required to participate in the PROMPT Study is based on the HL7® FHIR® standard for health care data exchange. The sites will need to comply with the specifications to submit data. ArborMetrix has created a template for sites to use with the necessary tab/column names needed. Sites should use this template as a starting point to alleviate setup burden.
During the data integration setup process, ArborMetrix will review with the site the clinical measures that will be populated using the site’s data. Understanding what these measures are will be important for the sites, as some of the information is very detailed and will pull from specific areas of the EHR. Without the detailed data, it will be harder to accurately calculate the measures and outcomes. Sites are encouraged to review the PROMPT Study Measure Specifications and Data Dictionary along with the Data Submission Guide to determine if there are any data elements they will not be able to submit to the PROMPT Study.
Minimum Data Elements Requirements
The following is an informal list of data elements that are required to join the PROMPT Study and participate in the PACE Registry. ArborMetrix will help you map the necessary elements required from your system as part of the data specifications testing process.
Data for the PACE Registry and PROMPT Study will be retrieved from the Electronic Health Record, Administrative and Practice Management Systems, and the Electronic Anesthesia Record. Cases to be included in the registry are all adult patients 18 years or older having postoperative nausea and vomiting (PONV) during their PACU stay, regardless of surgery or anesthesia type, etc. All data included in the registry will be deidentified. Comparison of deidentified patient EHRs in Cohort 1 and Cohort 2, including response rates, will be compiled and analyzed by an independent medical data analytics company, ArborMetrix.Collected data is encrypted and will only be stored electronically in a highly secured database. Data elements to be collected include:
After working with ArborMetrix to develop the data transmission file and working through connectivity, the site will send a sample data extract to ArborMetrix for data and measures validation. This will allow the site and ArborMetrix to develop and refine the pipeline. ArborMetrix will work with the site closely during this process.
Once a test dataset has been sent to ArborMetrix and validation of the measures is complete, the site will need to complete their own internal testing. Upon approval by all stakeholders, the interface will be deployed to production and the site will be considered “live.” A regular data submission cadence will be determined based on what works best for the site.
After the data submission is pushed to production, the site will meet with the program team for the PROMPT Study and will be trained on how to access the PACE Registry, receive full access to registry dashboards and understand available reports, benchmarks, etc.
Registry dashboards will be populated by pulling the EHR data provided by the sites and feeding it through an analytic process driven by the PROMPT Study clinical measures. Sites are encouraged to review the entire set of PROMPT Study measure specifications to understand the depth of information the PACE Registry will provide.
Your site will have web-based access to reports via the PACE Registry.