(88) Best practices for CFF Patient Registry: From consent to annual review

Background: The CFF Patient Registry (PortCF) collects health information of people with CF. This information is used for patient care, quality improvement (QI), and research. In 2016 we audited the PortCF consent/enrollment process to assess integrity and compliance. We continue to implement and improve that process. We have recently focused on our data entry process to ensure accurate and up-to-date information which is essential to our care team and the CFF.

Methods: Our site created two roles for PortCF management: a research coordinator (RC) for primary data entry and a registry coordinator (RegC) for oversight. RegC manages consent and enrollment into PortCF. At weekly care team meetings, she identifies patients for consent/re-consent for new enrollment, change in guardianship, or age of majority (AoM). After consent is obtained by RC, RegC reviews consent documentation to ensure completeness before adding patients to PortCF. The consent and diagnostic documentation is uploaded into PortCF at the time of enrollment. Patients are also added to a list in EMR which alerts RegC and RC when a patient needs AoM consent. Data entry is completed by RC the week following patient visits to ensure all data is available in EMR at time of entry. This includes data entered into the annual review. PortCF patient summary reports, run by RC, are used by care team as a pre-visit planning tool at weekly meetings. In advance, RC pre-reviews patient data to identify obvious outliers on reports. During meetings, it is determined who needs to see which patients and what tests need to be done based on PortCF reports. This is also an opportunity for QI /QA of outlier data. The RC/RegC checks the EMR and confirms/corrects data. RegC runs data analysis reports throughout the year to confirm/correct missing data i.e. test results or consults. At year end, RegC assists by running the incomplete records report to confirm encounters, episodes and annual reviews are complete before database lock. She will complete data entry for open records. Once all records are marked complete, she will run one last analysis report to confirm no data is missing.

Results: RegC managing enrollment ensures that only properly consented patients are added to PortCF and re-consent is obtained when needed before additional data is entered. This has resulted in continued regulatory compliance. RC completing data entry within a week of each study visit is invaluable to our care team and CFF. It ensures up-to-date reports for QI/research queries and patient review. Entering annual review data throughout the year has also proven to make database lock less burdensome. Using PortCF patient summary reports as a pre-visit planning tool allows care team to prepare for upcoming patient visits and helps ensure data accuracy and completeness. RegC running data analysis reports throughout the year and after all records are closed helps maintain the quality of data collection. RegC assisting with data entry at database lock has been crucial to maintaining timely data entry without overwhelming RC as she continues to enter data for the new year.

Conclusions: The separate RegC and RC roles has been beneficial to our PortCF process. It has created a sustainable process to maintain a compliant, up-to-date, and accurate database. We will continue to look for ways to improve our PortCF process to ensure that our care team and the CFF have quality data in a timely manner.

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