PaTH Towards a Learning Health System (PaTH)

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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 PaTH Towards a Learning Health System’s (PaTH) participation in PCORnet from 2015 to 2019. This report outlines PaTH’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

Led by the University of Pittsburgh, PaTH was made up of seven additional health systems serving eight states. The network used electronic health records, or EHRs, from its partners to conduct research projects that aimed to help healthcare providers and patients make better health decisions. The network focused on diverse research areas but had a special emphasis on healthy lifestyles and weight; a type of lung disease; and a type of irregular heartbeat that can lead to stroke or heart failure. Data are available on more than 13 million patients.

How does the network operate?

PaTH’s executive committee was made up of three lead researchers, two patients, a technology lead, and a data lead. The University of Pittsburg coordinated network activities and led the healthy lifestyles and weight research group. Penn State oversaw the lung disease research group. John Hopkins led the heart research group. It also served as the main Institutional Review Board (IRB), which made sure studies were ethnical and protected participants. Temple University oversaw a PCORnet CDM group.

PaTH signed data use agreements with all partners. 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?

Two patients had voting rights on the executive committee. The network also worked with healthcare providers at partner sites known as clinical champions. These champions helped make it easier for people working in healthcare settings to be in research studies. A network committee involved people from partner IRBs and the community to make sure that any research conducted focused on the patient. PaTH developed surveys for patients to get their opinions on research. Network members created easy-to-read summaries for patients of published studies that used PaTH data.

The network developed a story booth project where patients and caregivers shared their experiences about health and the healthcare system. People who participated could be matched with researchers leading studies on the same topic to form research teams where patients help guide the research. The story booth project worked with Patient-Powered Research Networks (PPRNs) and other community-based patient organizations to help patients and caregivers share their stories.

A stakeholder engagement work group oversaw these engagement activities.

Who is in the network?

The network had data on more than 13 million patients as of July 30, 2019. Data sources included Medicare insurance claims, EHRs, and relevant laboratory results and data on whether patients lived in rural, urban, or suburban areas. PaTH also had data from surveys patients filled out during their healthcare visits or as part of research surveys. Some partners had private insurance claims data. PaTH formatted EHR data about weight, lung function, and heart health to fit the CDM. Data are available since at least 2011, and prior to 2011 for most sites.

How is the network supporting research?

While a Partner Network in PCORnet, PaTH participated in 15 studies.

How does the network support future research?

PaTH follows PCORI standards to make sure their networks continue after PCORI’s funding ends. CDRNs format their data to the Common Data Model 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. PaTH developed a process by which informatics experts and clinical researchers engage research teams to help them develop projects within PCORnet and a payment system to fund the network. PaTH also works with diverse stakeholders across the country to create a website on patient stories and build research teams that include patients and caregivers and provide them with tools to support engagement.

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.

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.

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 PaTH Towards a Learning Health System’s (PaTH) participation in PCORnet from 2015 to 2019. This report outlines PaTH’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 University of Pittsburgh, PaTH comprises seven health systems in the Mid-Atlantic and midwestern regions.

The network uses electronic health records (EHRs) across its partners to conduct research that may ultimately help clinicians and patients make more informed health decisions. PaTH supports diverse research areas but has developed a particular focus on healthy lifestyles and weight; idiopathic pulmonary fibrosis; and atrial fibrillation. Data are available on more than 13 million patients.

Network Governance and Operations

The PaTH executive committee was made up of three PaTH principal investigators, two patient partners, a technology lead, and a methodological lead. The committee met monthly to review network progress and plan future directions. The University of Pittsburgh served as the network’s coordinating center and led the healthy lifestyles and weight research cohort. Penn State oversaw the idiopathic pulmonary research fibrosis cohort. John Hopkins led the atrial fibrillation research cohort and served as the Institutional Review Board (IRB) of record. Temple University convened the PCORnet Common Data Model (CDM) work group.

PaTH implemented data use agreements for all partners. Network partners stored patient data securely behind HIPAA-compliant firewalls. To answer research questions, the network provided de-identified data following stringent security procedures.

Stakeholder Engagement

Two patient representatives were voting members of the executive committee. The network also worked with partner site clinicians, known as clinical champions, to ensure that a proposed study could be integrated into a practice’s workflow or adapted as needed by local clinicians. The network’s protocol review committee involved representatives from partner IRBs and the community to ensure that research protocols emphasized patients’ perspectives. PaTH developed surveys for patients to gauge opinions on research; results are reported to the steering committee, which includes clinicians, clinical researchers, and informaticians and are used to help ensure that work is patient centered. Network members created patient-centered lay summaries of published studies that used PaTH data.

The network developed a story booth project where patients and caregivers shared their experiences about health and the healthcare system. Partnering community groups can help amplify their constituents’ voices and build their own story collections by partnering with the story booth project. The story booth narrative archive helps promote the development of research questions that focus on patient concerns and that can be analyzed qualitatively to increase understanding of patient perspectives. Furthermore, it serves as a systematic tool for matching patients with researchers who have shared interests to form engaged research teams. The story booth project worked with Patient-Powered Research Networks (PPRNs) to help members of those networks tell their stories and it has expanded beyond PCORnet with funding from a Eugene Washington PCORI Engagement Award.

A stakeholder engagement work group made up of clinicians, engagement experts, and project managers and a patient partner from each PaTH site oversaw these engagement activities.

Network Demographics

The network had data on more than 13 million patients as of July 30, 2019. Data sources included Medicare and Medicaid claims, EHRs, relevant laboratory results, and patient-reported surveys on topics related to healthy lifestyles, body weight, atrial fibrillation, and idiopathic pulmonary fibrosis, as well as information on patients’ mental health and physical fitness. Data are available since at least 2011, and prior to 2011 for multiple sites.

Demonstrating Research Capacity

While a Partner Network in PCORnet, PaTH participated in nine observational studies and six clinical trials. PaTH placed a particular focus on patient engagement and pragmatic recruitment approaches.

Future Opportunities

PaTH follows 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. PaTH developed a fee-for-service model to fund its infrastructure. The network also works with individual patients, caregivers, clinicians, educators, health plan representatives, researchers, and other community-based patient organizations to create a patient-centered website that fosters online story sharing and a transparent process for building stakeholder-engaged research teams and equipping them with tools to help support engagement.