FREQUENTLY ASKED QUESTIONS

If you or your loved one’s care center is not yet a member of FON, we hope they will join us! FON accepted new care center applications from April of 2023 through July of 2023. FON will be open to new applications again in April of 2024. You can encourage your care center to learn more about FON by carefully reading through our Application Informational Packet which lists the benefits and expectations of FON care centers, as well as the participant fee.

New care centers can begin the FON IRB/DUA process as soon as they are accepted to the network. Our most recent group of new centers began full onboarding in July of 2023.

FON is accepting new care center applications starting March 3, 2022. We encourage all interested care centers to carefully read through our FON Application Packet, which lists the benefits and expectations of FON care centers, as well as the participant fee.

All interested care centers then must complete our online application, which includes a commitment of support from the leadership at your Care Center. The deadline for care centers to apply is May 2, 2022.

New care centers can begin the FON IRB/DUA process as soon as they are accepted to the network. They will begin full onboarding to the network in July 2022.

We anticipate there will be a lot of interest and we want to accommodate that as quickly and smoothly as possible. Moving forward, FON will accept new centers on an annual basis. Please email info@fontanoutcomesnetwork.org if you have any questions or need any assistance with the application process.

During this initial stage, FON Care Centers are limited to the United States due to IRB regulations. We hope to expand FON internationally in future years.

There will be learning events open to the general community starting in 2022, in the United States and internationally. FON's monthly newsletter is the best way to find out more information about these opportunities. You can sign up for the newsletter using the form at the bottom of FontanOutcomesNetwork.org.

Care Centers can take several action steps now to prepare to join FON in the future. Care Centers can start by speaking with their hospital administration regarding their interest. They can also promote FON within their centers to other clinicians, patients, parents, and administrators.

Care Centers should follow FON on social media and join FON's monthly newsletter, which is the best way to find out more information about these opportunities.

FON will requires centers to start collecting encounter data for each participant at least annually.

The ultimate goal of FON is to collect comprehensive longitudinal visit based data, when feasible. We are planning for EHR integration, but expect this process to take several years to implement. Until then, data collection at most centers will depend heavily on manual entry. We are deeply committed to working with centers to streamline data collection, so please reach out if you have ideas or questions.

There will be opportunities to interact with FON prior to additional Care Centers being added such as through learning sessions, Single Ventricle Patient Day, educational webinars, and more. We encourage you to follow FON on social media and sign up for our newsletter to find out more information about these opportunities. You can sign up for the newsletter using the form at the bottom of FontanOutcomesNetwork.org.

Care Centers should establish a multidisciplinary team with expertise in the areas of focus for FON and sufficient authority to effect change in these areas. A team may optimally include, but is not limited to, the following:

• Pediatric and/or adult cardiologist (required)

• Individual with SVCHD and/or a parent of a child with SVCHD (required).

We recognize that not all centers have experience with having a patient or parent integrated into their team. Our FON project team can help you with how to move forward on this.

• NP/RN/PA

• Psychologist

• Social Worker

• Research Coordinator

• Collaboration with key specialties, such as hepatology, neurodevelopment, nephrology, exercise physiology and cardiac rehab, information services, and radiology

Some questions to consider when forming your team include:

• Do you have a data or research coordinator who is ready to engage?

• Have you identified a parent or patient champion?

• Who at your center is passionate about FON research or quality improvement?

The fee to participate in FON is $15,000 per academic calendar year (July-June) per care center. This fee is subject to change.

The annual fee of $15,000 enables the network to sustain current operations and support critical quality improvement and data collection activities. The fee provides partial support for the Network so that care center teams can:

• Learn from colleagues about best practices, effective tools, and strategies

• Improve care and outcomes for individuals with SVCHD

• Learn and apply formal Quality Improvement methods

• Utilize the Network to address patient safety and quality improvement metrics

• Use registry data for research

Care Centers can take several action steps now to prepare for the FON registry launch.

First, they should identify a Key Contact who will serve as the primary liaison for FON communications and ensure that person is receiving and reading the weekly FON newsletter, which contains important information and notifications.

Second, they can start to build their Care Center teams. In addition to the Key Contact, this can include clinicians, parent and/or patient representatives, a data and/or research coordinator, as well as other multi-disciplinary clinicians who work with the Fontan population.

Finally, care centers can do the following in preparation for the registry launch:

• Review the FON Data Collection Forms

• Draft an enrollment process map

• Complete the steps outlined in the Regulatory and Legal Agreement packet.

Please email ereg-FON@cchmc.org if you have any questions regarding the IRB/DUA process or if you are an existing FON care center and have not received the packet.

When the registry is launched in summer 2022, FON will require centers to start collecting encounter data for each participant at least annually.

The ultimate goal of FON is to collect comprehensive longitudinal visit based data, when feasible. We are planning for EHR integration, but expect this process to take several years to implement. Until then, data collection at most centers will depend heavily on manual entry. We are deeply committed to working with centers to streamline data collection, so please reach out if you have ideas or questions.

No. Ideally, we would like centers to collect monthly sample data on a wide variety of patients.

When the registry is launched in summer 2022, centers will collect longitudinal data for each participant at least annually. In addition, centers will collect monthly data on a subset of encounters to inform QI and plan for future integration of longitudinal encounter-based data collection. The initial focus will be on enrollment, and we are targeting January 2023 to start collecting this sample of visit-based data.

FON is finalizing the data collection forms now and preparing them for the registry vendor. You can access a draft version of the forms here. Please be aware that these forms are subject to minor changes, and updates will be posted. As a reminder, care centers can only start collecting patient data after they have received IRB approval.

The FON registry has launched. Participating Care Centers can start enrolling patients once the required regulatory steps have been completed.

The Regulatory & Legal Agreement Packet for FON was sent to current FON care centers in July of 2023. Our next onboarding class with be in July of 2024.

If you have any questions regarding the IRB/DUA process, need to request that these documents be re-sent, or would like to view a recording of the regulatory webinar, please email ereg-FON@cchmc.org.

FON is using a single IRB as is frequently being done for efficiency. All centers will need to rely on the CCHMC IRB. Care Centers will review the initial IRB and then use the CCHMC IRB for review. If your site has questions or concerns with this process, please reach out to the CCHMC regulatory coordinator who will work with you and your site’s specific requirements.

Given the overlapping missions and close partnership of these two networks, the leadership teams of both FON and NPC-QIC have decided that the networks will enhance collaboration​ and work towards becoming one organization ​to create a lifespan registry for single ventricle patients. The timing and Care Center participation requirements will be among the many details that will be thoughtfully considered in the months ahead as a more robust plan is developed.

We anticipate that the registry will be launched, and enrollment with data entry will start for the initial Care Centers, in Summer 2022.

The FON registry will not be based on the REDcap platform. It will be built directly into a platform of the Broad Institute of MIT and Harvard.

The Broad Institute is developing a custom registry for FON. To ensure user-friendliness and appropriate features, the development process is being informed by many hours of interviews that the Broad team conducted with staff of other learning health networks and users of existing registries systems as well as members of the FON and single ventricle community. The Broad team is uniquely suited to plan and develop the more advanced features important to the longer-term goals of EHR integration and linkages with other registries.

FON's initial focus is to launch the registry to enable enrollment and data collection as soon as possible. The current scope of work with our registry development partner includes developing a plan to link FON with other registries. FON's IRB protocol, informed consent, and data use agreement all support linking data with other registries to enhance the value of the information collected. There will be many details to address with each participating center and the other datasets, however, and we expect this process to take several years to implement.