The Patient-Centered Network of Learning Health Systems (LHSNet)

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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.

Clinical Data Research Networks (CDRNs) are one type of network supported by PCORI. CDRNs consist of two or more healthcare systems, including hospitals, integrated delivery systems, and federally qualified health centers. Each CDRN transforms data gathered from routine patient care across its participating health systems to a consistent format, the Common Data Model (CDM), to enable rapid response to research-related questions.

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

1. Create ways to involve patients, healthcare providers, health plans, and health systems in the research process and decision making about the network
2. Continue building the PCORnet CDM to add new types of data, ensure data quality, answer questions and requests, link to data outside the network, and keep data secure and private
3. Create an efficient infrastructure to carry out clinical trials
4. Create rules and guidance to protect people who take part in research studies, keep participants’ information confidential, and examine the risks of proposed studies
5. Work with PCORnet partners and partners outside the network to do research studies, build information systems, and share knowledge and practices
6. Create a plan to fund the network after PCORI funding ends

Network at a glance

The Mayo Clinic led LHSNet. LHSNet brought together seven other healthcare systems, as well as public health departments and health plans in 13 states. LHSNet’s goal was to help researchers find out what matters to patients and carry out comparative effectiveness research. This type of research compares two or more treatments to see which one works better for which patients. LHSNet also wanted to share these research results to improve public health.

How does the network operate?

LHSNet created a Steering Committee to lead the network. The committee included LHSNet leaders and research study leads from partner sites.

LHSNet created four committees to oversee how the network operates. Each committee focused on a core area:

• Research
• Data quality and informatics
• Engaging patients and other partners
• Complying with regulations

Mayo Clinic staff led each core committee along with members from each partner site. LHSNet also created a Coordinating Committee that included all LHSNet site project managers.

LHSNet created a team of experts to improve data quality processes across sites. This helped data systems and practices work together across sites.

Network partners stored patient data securely. To answer research questions, the network provided data that cannot be used to identify patients and followed strict security rules.

How did the network involve patients and other partners?

The project team invited two experts on involving patients in research studies to join the LHSNet engagement core committee. These experts reviewed ways to engage participants across PCORnet projects. This review helped LHSNet partner sites engage patients.

Partner sites aimed to involve patients in the research process. Study teams at each site engaged participants in their own way. Sites taught patients about the research process. Some sites created special tools to orient patients to the research process. Other sites offered trainings for study teams to help engage faculty, researchers, and medical professionals.

Who is in the network?

LHSNet brought in data from 15,409,215 patients as of March 31, 2019. Data came from electronic medical records and administrative claims. Data also came from patient surveys on heart failure, weight, and other health issues.

*Demographics are for a subset of the total population.

How is the network supporting research?

While a Partner Network in PCORnet, LHSNet participated in seven research studies.

How does the network support future research?

CDRNs follow PCORI standards to make sure their networks continue after PCORI’s funding ends. CDRNs format their data to the CDM and involve patients and healthcare providers in planning and carrying out research studies. CDRNs also take part in research with other networks in PCORnet and build relationships outside of PCORnet.

Glossary

Clinical Data Research Networks (CDRN): CDRNs are networks that originate in healthcare systems, such as hospitals, health plans, or practice-based networks, and securely collect health information during the routine course of patient care.

Common Data Model (CDM): A CDM establishes a standard way of defining and formatting data.

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

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

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.

Clinical Data Research Networks (CDRNs) are one type of network supported by PCORI. CDRNs consist of two or more healthcare systems, including hospitals, integrated delivery systems, and federally qualified health centers. Each CDRN transforms data gathered from routine patient care across its participating health systems to a consistent format, the Common Data Model (CDM), to enable rapid response to research-related questions.

PCORI funded LHSNet’s participation in PCORnet from 2015 to 2019. This report outlines LHSNet’s achievements in developing and optimizing research infrastructure capacity to

1. Engage patients, practicing clinicians, health plans, and health systems meaningfully in network governance and the research process
2. Continue building the PCORnet CDM to support new data elements, maintain high-quality data sets, respond to queries, link to external data sources, and ensure patient privacy and data security
3. Establish an efficient infrastructure for conducting clinical trials
4. Develop research oversight infrastructure that protects research subjects, preserves participants’ confidentiality, and evaluates the risks of proposed studies
5. Collaborate with PCORnet and external partners to conduct research studies, build infrastructure, and share knowledge and practices
6. Develop a plan for financial sustainability beyond the PCORI infrastructure-funding period

Network Infrastructure

Led by the Mayo Clinic, LHSNet brought together seven additional healthcare systems, as well as data from private health plans in 13 states. LHSNet’s goal was to facilitate patient-centered outcomes and comparative effectiveness research and enable the dissemination and implementation of efforts to improve population health.

Network Governance and Operations

LHSNet created a Steering Committee to lead the network. The Steering Committee included LHSNet leadership, partner site principal investigators, and core operating committee leaders.

To oversee the network’s operations, LHSNet established four core operating committees. Each committee focused on one topic: research, data quality and informatics, engagement, and regulations.

Mayo Clinic staff led each of these committees, which included members from each partner site. LHSNet also had a Coordinating Committee made up of all LHSNet site project managers.

LHSNet brought together a team of experts to improve data quality processes across partner sites. This initiative helped synchronize divergent data technologies, standards, and practices across sites.

Network partners store patient data securely behind HIPAA-compliant firewalls. To answer research questions, the network provides deidentified data following stringent security procedures.

Stakeholder Engagement

The project team invited two engagement experts to join the LHSNet engagement core committee. These individuals developed white papers, including an environmental scan of engagement strategies across PCORnet, to inform engagement activities in LHSNet partner sites.

Stakeholder engagement occurred across each partner site and was specific to each research study. Partner sites aimed to involve patients throughout the research process. Sites worked within their respective compliance infrastructures to help introduce patient advisors to the research process or offer trainings for study teams on engaging with faculty, researchers, and medical professionals.

Network Demographics

LHSNet aggregated data from 15,409,215 patients as of March 31, 2019. Data sources included electronic medical records, administrative claims, and survey data from patients on heart failure, osteogenesis imperfecta, weight, and other patient-reported outcomes.

*Demographics are for a subset of the total population.

Demonstrating Research Capacity

While a Partner Network in PCORnet, LHSNet participated in four clinical trials and three observational cohort studies.

Future Opportunities

CDRNs follow PCORI standards to enhance the sustainability of the network, including adhering to the CDM, fostering patient and clinician engagement at all stages of the research process, participating in multinetwork PCORnet research, and building external collaborations.