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Pilot Projects Link PCORnet, FDA’s Sentinel Program

May 19, 2017
by David Raths
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Projects will bring together EHR and claims data to create more complete picture of overall health

Two pilot projects under way are seeking to demonstrate the value of data linkage between the Patient-Centered Clinical Research Network (PCORnet) and other distributed networks, such as the U.S. Food and Drug Administration’s Sentinel program.

While PCORnet predominantly contains electronic health record clinical data, Sentinel uses claims data to monitor the safety of regulated medical products, including drugs, vaccines, biologics, and medical devices. Both EHR and claims data offer valuable insights that, when combined, allow for a more complete picture of overall health.

Funded through a public-private partnership with the Patient-Centered Outcomes Research Institute (PCORI), the FDA and the Regan-Udall Foundation (participating in an advisory capacity), this collaboration seeks to advance patient-centered research in regulatory science and enhance patient-clinician decision-making.

The two pilots began in November 2016 and involve researchers in partnership with PCORnet’s OneFlorida Clinical Data Research Network and the Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN).

The OneFlorida project focuses on leveraging EHR and claims data to reduce transmission rates of the mosquito-borne Zika virus. While most people infected with the Zika virus will only experience mild or even nonexistent symptoms, women who are infected with Zika during pregnancy are at risk of having babies that suffer from a birth defect of the brain called microcephaly and other severe brain and birth defects. This project is working to develop a strategy for tracking the number of babies born with microcephaly within OneFlorida’s Clinical Data Research Network. Ultimately, the project team will categorize database information on infants born with microcephaly and work with the Sentinel team to enhance surveillance of congenital Zika syndrome.

The CAPriCORN pilot seeks to harmonize data on usage of antimicrobials, which include drugs such as antibiotics, antivirals and antifungals. Because most bacteria, viruses, and other microbes multiply rapidly, they can quickly evolve and develop resistance to antimicrobial drugs, making it challenging to treat and control the spread of infections from multi-drug resistant organisms. This project will use the PCORnet Common Data Model to develop an open source methodology that can help the Centers for Disease Control and Prevention National Healthcare Safety Network, the FDA’s Sentinel program and local hospital administrations detect and analyze pathogen trends and understand how best to minimize antimicrobial resistance.

 “Collaborations like this will be essential if we’re going to transform traditional clinical research, conduct definitive studies, and put people and other healthcare stakeholders in the driver’s seat to enable better informed healthcare decisions,” said Joe Selby, M.D., M.P.H., executive director of PCORI, in a prepared statement.

The FDA and PCORI are providing separate funding for both pilot projects, which are expected to conclude in autumn of 2018.

 

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Kaiser Creating Evidence-Based Complex Care Models

January 17, 2019
by David Raths, Contributing Editor
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Work aligns with recently published ‘Blueprint for Complex Care’

The National Center for Complex Health and Social Needs recently published a “Blueprint for Complex Care” to develop a collective strategy for promoting evidence-based complex care models. Recognizing that many patient issues have root causes that go beyond the medical, the Blueprint seeks to identify best practices for breaking down silos between the social care delivery system and healthcare.

Perhaps no health system has devoted as many resources to complex care as Kaiser Permanente. Its Care Management Institute, a joint endeavor between the Permanente Medical Groups and Kaiser Foundation Health Plan, has established Complex Needs as one of its national quality initiatives. It has named regional complex care leaders, created common quality measures across regions and established a complex need research arm called CORAL. (Kaiser Permanente has eight Permanente Medical Groups and regions, more than 12.2 million members, more than 22,000 physicians and 216,000 employees.)

In a Jan. 16 webinar presentation, Wendolyn Gozansky, M.D., vice president and chief quality officer, Colorado Permanente Medical Group and national leader for complex needs at the Care Management Institute, described Kaiser Permanente’s efforts and used some personal anecdotes to explain their goals.

She said Kaiser Permanenteis working on the concept of developing core competencies and tools to support a longitiudinal plan of care for patients with complex needs. “These are the folks for whom the usual care is not meeting their needs,” she said. “How do you recognize them and make sure their needs are being met?”

Gozansky gave an example from a patient she had just seen the previous wekend. This women had fallen and broken her hip. She had several chronic conditions, including significant asthma, yet she was not on an inhaled steroid.

“One concept I love from the Blueprint is that this field is about doing whatever it takes to meet the needs of the person in front of you,” she said. In speaking to the woman, she came to understand that singing in a church choir was the most important thing in her life, and the inhaler medication was making her hoarse and unable to sing.  She was fairly isolated socially except for church. “My goal was to get her rehabbed and leverage the patient-defined family that is supportive. Her goals are to sing, so we need to do what is possible to get her back to that. We have to capture that information, put it into a long-term plan of care. The goal is not to get her out of rehab but to get her singing in choir.”

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The health system has to work on care that is preference-aligned. The woman is not on a steroid inhaler but her care is preference-aligned. How does the health system assure that everyone knows they are doing the right thing?

Gozansky said the beauty of Permanente Medicine is that its setup involves an employed medical group focused on value, not volume. They can interact with health plan partners in delivery of new systems of care. “It is a virtuous cycle about value and person-centered care. This is what our complex needs team is trying to understand.”

She described the journey so far: In 2015 there were pockets of work being done across the eight Kaiser Permanente regions. In 2016 they established complex care as a national qualitiy iniative. “We knew we were not meeting these patients’ needs. We had to figure out the right way to do that.” They also realized that most of the previous research on the topic involved examples that were not in integrated systems such as Kaiser Permanente. “We had to figure it out in an integrated system,” she said.

 In 2017 they started working on cross-regional learning — for instance, taking a program from Colorado and trying it in Southern California. Then they sought to align quality measures. In 2018 they got funding to create CORAL, the complex needs research arm.  

The Care Management Institute has created a “community of practice” on complex care to break down silos within the organization and bring together research, operational and administrative executives. They also want to work with external stakeholders to make sure what they are developing is scalable, Gozansky said.

Mark Humowiecki, senior director of the National Center for Complex Health and Social Needs, also spoke during the webinar. He said one of the goals of the Blueprint was to get a clearer definition. Some people get confused about terms such as “hotspotting” and complex care, he said. He said there is a recognition that these patients’ needs are crossing traditional silos, so “there is a need to connect care for the individual but also at the system level.”

The goal, he added, is to create a complex care ecosystem by developing in each community system-level connections between social care delivery and healthcare, which in the past have operated too independently.  The five principles are that complex care is person-centered, equitable, team-based, cross-sector and data-driven. One of the Blueprint’s recommendations is to enhance and promote integrated cross-sector data infrastructures.

 

 


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NIH’s All of Us Program Teams with Fitbit for Data Collection

January 16, 2019
by Heather Landi, Associate Editor
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The All of Us Research Program, part of the National Institutes of Health (NIH), has launched the Fitbit Bring-Your-Own-Device (BYOD) project. Now, in addition to providing health information through surveys, electronic health records, and bio-samples, participants can choose to share data from their Fitbit accounts to help researchers make discoveries.

According to All of Us research program officials, the project is a key step for the program in integrating digital health technologies for data collection.

The All of Us Research Program, established by the White House in 2015, aims to advance precision medicine by studying the health data of 1 million diverse Americans over the next five years. One aim of the project is to include groups that have been historically underrepresented in research. As of September 2018, more than 110,000 people have registered with the program to begin the participant journey, and more than 60,000 have completed all elements of the core protocol.

The participants are sharing different types of information, including through surveys, access to their electronic health records and blood and urine samples. These data, stripped of obvious identifiers, will be accessible to researchers, whose findings may lead to more tailored treatments and prevention strategies in the future, according to program officials.

Digital health technologies, like mobile apps and wearable devices, can gather data outside of a hospital or clinic. This data includes information about physical activity, sleep, weight, heart rate, nutrition, and water intake, which can give researchers a more complete picture of participants’ health.” The All of Us Research Program is now gathering this data in addition to surveys, electronic health record information, physical measurements, and blood and urine samples, working to make the All of Us resource one of the largest and most diverse data sets of its kind for health research,” NIH officials said.

“Collecting real-world, real-time data through digital technologies will become a fundamental part of the program,” Eric Dishman, director of the All of Us Research Program, said in a statement. “This information, in combination with many other data types, will give us an unprecedented ability to better understand the impact of lifestyle and environment on health outcomes and, ultimately, develop better strategies for keeping people healthy in a very precise, individualized way.”

All of Us participants with any Fitbit device who wish to share Fitbit data with the program may log on to the All of Us participant portal at https://participant.joinallofus.org and visit the Sync Apps & Devices tab. Participants without Fitbit devices may also take part if they choose, by creating a free Fitbit account online and manually adding information to share with the program.

All of Us is developing additional plans to incorporate digital health technologies. A second project with Fitbit is expected to launch later in the year, NIH officials said, and this project will include providing devices to a limited number of All of Us participants who will be randomly invited to take part, to enable them to share wearable data with the program.

The All of Us research program plans to add connections to other devices and apps in the future to further expand data collection efforts and engage participants in new ways.

Related Insights For: Population Health

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NorthShore to Lead “Largest Primary Care-Based Genomics Program in U.S.”

January 14, 2019
by Rajiv Leventhal, Managing Editor
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The Chicago-based NorthShore University HealthSystem and genomics technology company Color are partnering on a new initiative that will aim to deliver the power of genomics to routine primary care at population scale.

Known as "DNA10K," the initiative will engage more than 10,000 patients and will be the largest known primary care-based genomics program in the U.S., according to officials who made an announcement last week.

The approach will build on NorthShore's years of experience in genomics and actionable electronic medical records (EMR) information, while providing access to Color's clinical-grade genetic testing and whole genome sequencing to inform patients about their risk for certain hereditary conditions, according to company executives.

“The knowledge will help patients learn about their genetic makeup, including risk factors for certain disease types such as common hereditary cancers and heart diseases. This insight will help NorthShore personalize care for each patient to support improved outcomes, prevention and overall health,” officials noted.

The announcement comes on the heels of a recent pilot between NorthShore and Color that looked to unlock the benefits of genetic information in routine care.

As officials explained, in less than two months, more than 1,000 patients signed up for the Color population health program as a part of their primary care visit, an adoption rate of more than 40 percent of those eligible and significantly beating expectations of the pilot program. “This is a strong indicator of patients' interest in understanding genetic factors that can influence health and the opportunity to work with NorthShore care providers to make more informed treatment or prevention decisions,” they attested.

Overall, the DNA10K initiative supports NorthShore's efforts to improve patients' health outcomes at a population level, with genomics as a foundation for informing individualized healthcare.

Patients who take advantage of the "DNA10K" offering will provide a blood sample, which is then analyzed in Color's CLIA-certified, CAP-accredited lab, and results are returned to healthcare providers and their patients. In addition to their NorthShore primary care provider, patients will also have access to board-certified genetic counselors and clinical pharmacists from Color and NorthShore, officials explained.

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