Cerebral Palsy Registry Rollout Begins
CPRN Epic EMR Form
The Cerebral Palsy
Research Network (CPRN) Registry forms went into production at the lead registry site — Nationwide Children’s Hospital (NCH) – this week. NCH’s Cerebral Palsy Program Director and CPRN executive committee member Dr. Garey Noritz used the forms when seeing patients in clinic on Monday, April 25, 2016. “I would say this went fairly smoothly,” said Dr. Noritz. “I found it straightforward to use this flowsheet as part of my regular clinical interview with patients, and it did not make my visit any longer.”
The CPRN Registry forms, which are built into the Epic electronic medical record (EMR) system, represent a breakthrough in disease registry data collection. Most clinical registries are populated by clinical research assistants that “abstract” or interpret the data from the patient’s medical record and transcribe it into another form which takes time and resources and can be error prone because of the duplicate data entry. The CPRN Registry forms are built directly into the EMR for use by the providers that treat people with cerebral palsy. These built-in forms will eliminate duplicate data entry, additional personnel expense and reduce errors by leveraging the domain knowledge of the provider. Registry data will also be more current because the information is captured at the time of treatment rather than entered into the registry after the patient visit or intervention.
The CPRN Registry forms will be used at NCH for the next few months before being rolled out at other sites but this milestone is a critical proof point for the CPRN Common Data Model which defines the data that is to be collected for the registry.
The Cerebral Palsy Research Network (CPRN) has invited adults with cerebral palsy and caregivers of adults to join an adult registry study panel. The panel will partner with clinicians and providers who have led the creation of adult registry elements for the CPRN Registry. The panel will help determine study questions that are most important to adults with CP and have an opportunity to participate in the research process. The CPRN Adult Registry group is co-led by Mary Gannotti, PT Ph.D. and Debbie Thorpe, PT Ph.D. and includes providers from a wide range of disciplines who treat adults with (or children or both) CP. The adult registry study panel will be organized by Michele Shusterman of CP Now Foundation and CP Daily Living in her role as the Patient Engagement Leader on the CPRN leadership team. The panel members will represent a group of people with CP with diversity among age, race, gross motor function, and cognitive abilities.
CPRN plans to invite a similar panel to participate in the CPRN Registry efforts for children. Both groups will be extended opportunities to influence the overall research agenda for CPRN at a future planning meeting. The engagement of patient stakeholders in research has been demonstrated to enhance the impact of clinical research and is integral to the mission of CPRN.
The CPRN Registry Protocol, a formal description of the plans, purpose and data to be collected, safety and monitoring for the CPRN Registry research project, was submitted to the Nationwide Children’s Hospital (NCH) Institutional Review Board (IRB) today. The IRB’s role is to assure the protection of human subjects in research such that it is in accordance with all federal, institutional, and ethical guidelines. The submission of this protocol is a significant milestone in the progress of CPRN to launch a national cerebral palsy registry. It is significant for numerous reasons:
The IRB protocol approval is a required step to begin the collection of patient data for research;
- Nationwide Children’s Hospital, as part of PEDSnet, enables us to take advantage of the Master Reciprocal IRB Reliance Agreement among PEDSnet institutions of which several are also part of CPRN including AI duPont Hospital, Boston Children’s Hospital, Children’s Hospital of Colorado, Cincinnati Children’s Hospital and Seattle Children’s Hospital;
- Sites that are not part of PEDSnet can do a project specific reliance agreement;
- Once the IRB protocol is approved, all other CPRN sites will be able to submit the CP registry protocol to their IRBs;
- When CPRN seeks to expand its registry, other sites will be able to quickly gain IRB approval through the reliance mechanism.
The CPRN Registry IRB Protocol was submitted at Nationwide Children’s Hospital by Dr. Garey Noritz who is the Director of the Cerebral Palsy Program at NCH and one of the leaders of CPRN. The IRB Protocol can be found on the CPRN Resources page. CPRN appreciates the efforts of Dr. Noritz and Nationwide Children’s Hospital in launching the CPRN Registry.