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PCORI funded the development of PCORnet^®, the National Patient-Centered Clinical Research Network, to make it easier and more efficient to conduct research. PCORnet is made up of Partner Networks that harness the power of large amounts of health data and patient partnerships.

Patient-Powered Research Networks (PPRNs) are networks operated and governed by patients, families, caregivers, and community members in close collaboration with clinical researchers, with the goal of shaping and conducting research to better serve their communities and improve their health outcomes. Several PPRNs, including ImproveCareNow (ICN), participated as Partner Networks in PCORnet.

PCORI funded ICN’s participation in PCORnet from 2015 to 2019. This report outlines ICN’s achievements in building its research infrastructure capacity to

1. Create ways to involve patients, families, and caregivers in decision making about the network
2. Create a way to collect and share data reported by patients for research
3. Involve patients, caregivers, families, and communities in the research process, including recruiting people to participate in research studies
4. Lead or join in research studies that focus on the community’s priorities

Network at a glance

ICN was established to transform the health and care of all children and adolescents with inflammatory bowel disease, or IBD. IBD refers to two diseases: Crohn’s disease and ulcerative colitis. These disorders cause chronic swelling and irritation of the digestive tract. They can cause severe diarrhea, abdominal pain, fatigue, and weight loss; serious complications may also occur. ICN built a community in which clinicians, researchers, parents, and patients can work together to innovate and discover and apply new knowledge.

As of March 2019, ICN included 109 care centers that treat IBD and range in size from small private practices to large children’s hospitals. Among these centers, 97 are in the United States, 9 are in Belgium, 2 are in the United Kingdom, and 1 is in Qatar. These care centers enroll patients into an ICN database, called a registry, and collect standard information from the patients during all doctors’ visits. The ICN registry, which includes data on more than 38,000 patients, is available for use in research studies approved by ICN’s research committee.

How does the network operate?

ICN created a process for care centers to join the network, which included signing legal agreements such as data usage agreements and getting approval from an external organization called an Institutional Review Board, or IRB. An IRB reviews studies to ensure they protect the rights of participants. ICN also set rules for researchers asking to use ICN registry data in their studies. For example, researchers must follow approval guidelines laid out by a committee that oversees all research within ICN. In addition, researchers conducting studies using the ICN registry of patients must include parents and patients in the different phases of their research projects.

How did the network involve patients and other partners?

Parents and patients serve in leadership roles in ICN; they also serve on working groups and committees and lead and participate on research teams. Parents and patients designed and reviewed research projects. They also helped create guides available to the ICN community. For example, one guide showed how parents, patients, and researchers can work together on research studies. Parents and patients also created a booklet for teens and young adults with IBD on body image issues and another booklet for patients who had a specific type of surgery. On the ICN blog, called LOOP, ICN launched a new series called Research Explained, which summarizes research so that everyone can understand and take advantage of what is being learned.

Who is in the network?

ICN had 38,846 enrolled patients as of March 31, 2019. Care centers in the network approached patients about becoming a part of the network and obtained consent to use their health data. ICN receives patient information from each care center, including age, race and ethnicity, sex, health history, disease symptoms, treatment history, and other medical information.

While a Partner Network in PCORnet, ICN participated in nine studies. ICN collaborates with other networks and companies that develop medicines.

How does the network support future research?

ICN receives yearly membership fees from the care centers that take part in the network. In addition, ICN gets donations from individuals and organizations.

Glossary

Institutional Review Board (IRB): A group that follows federal regulations, state laws, and institutional policy to review, monitor, and approve research studies in order to protect the rights and privacy of the subjects involved.

Patient-Powered Research Networks (PPRN): PPRNs are operated and governed by patient groups and their partners and are focused on particular conditions or populations.

PCORnet: PCORnet is a network of networks that brings together patients, clinicians, researchers, and healthcare systems to share information and participate in research.

Overview

PCORI funded the development of PCORnet^®, the National Patient-Centered Clinical Research Network, to make it easier and more efficient to conduct research. PCORnet is made up of Partner Networks that harness the power of large amounts of health data and patient partnerships.

Patient-Powered Research Networks (PPRNs) are networks operated and governed by patients, families, caregivers, and community members in close collaboration with clinical researchers, with the goal of shaping and conducting research to better serve their communities and improve their health outcomes. Several PPRNs, including ImproveCareNow (ICN), participated as Partner Networks in PCORnet.

PCORI funded ICN’s participation in PCORnet from 2015 to 2019. This report outlines ICN’s achievements toward the PPRN goals of developing and optimizing research and engagement infrastructure capacity to

• Establish a governance structure that fully engages patients and other stakeholders for the purposes of contributing to research
• Create a data infrastructure conducive to the ongoing collection of patient-reported data
• Meaningfully engage patients, caregivers, families, and community members in the research process, including identifying and recruiting participants for clinical trials and other research studies
• Lead or partner in the conduct of comparative effectiveness studies responsive to the research priorities of their communities

Network Infrastructure

ICN was established to transform the health and care of all children and adolescents with Crohn’s disease and ulcerative colitis (also called inflammatory bowel disease or IBD) by building a sustainable and collaborative chronic care network. A collaborative community empowers clinicians, researchers, parents, and patients to work together to accelerate innovation, discovery, and the application of new knowledge through research and quality improvement.

By March 2019, ICN included 109 care centers ranging in size from small private practices to large children’s hospitals, including 97 centers in the United States, 9 in Belgium, 2 in the United Kingdom, and 1 in Qatar. These care centers enrolled patients into the ICN registry and collected standard data from these patients during all clinic visits. The ICN registry includes analysis-ready data for more than 38,000 patients.

Network Governance and Operations

Requirements for care centers joining the ICN network included Institutional Review Board approval and signed legal documents, including a data usage agreement. In addition, an ICN research committee established standard procedures to review research study proposals requesting the use of data from the ICN registry. The committee includes researchers, clinicians, parents, and patients. Procedures detail ICN expectations for stakeholder engagement in research such as involving parents and patients on research teams or consulting with parents and patients on study design and execution and in disseminating research results.

Stakeholder Engagement

Parents and patients participate in all aspects of the network. Parents and patients serve on the ICN board of directors, research teams, and committees overseeing ICN strategy and research. They also help design, review, and execute ICN work, including contributing to the design of tools and resources available on the ICN website for the entire ICN community. Researchers, clinicians, and parents co-developed these tools to facilitate parent and patient engagement in research and quality improvement. Likewise, parents and patients developed a toolkit for teens and young adults with IBD on the topic of body image issues and another toolkit for patients who had a specific type of surgery. ICN disseminates tools and research results through its network. The ICN LOOP blog includes a series called Research Explained, in which parents, patients, and researchers write summaries of research so that everyone can understand and take advantage of what is being learned. Care centers in the network use systematic quality improvement methods to implement research findings.

Demographics and Research Capacity

ICN had 38,846 enrolled patients as of March 31, 2019. ICN receives patient data from care centers within the network including patient demographics, identifiers, health history, symptoms, biometrics, treatment history, and vital signs.

While a Partner Network in PCORnet, ICN participated in nine studies including one clinical trial, one N-of-1 study, and seven observational studies. ICN collaborated with other PPRNs and Clinical Data Research Networks, including PEDSnet. In addition, ICN works with pharmaceutical partners on clinical trials.

Future Opportunities

ICN’s sustainability model includes annual participation fees and in-kind support from participating care centers. In addition, ICN received philanthropic donations and grant funding.