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Analysis

A Million Participants? How NIH Program Will Scale Data Delivery and Ensure Continuity of Care

By Mandy Roth  
   August 26, 2019

NIH All of Us Research Program may set precedents for large-scale data delivery using a technology platform that maximizes efficiencies and involves telehealth consults with genetic specialists.

How do you scale a genetic testing research program to provide results, counseling, and referral services to one million people?

The National Institutes of Health (NIH) All of Us Research Program has turned to the private sector for the technology platform and genetic counseling specialists to make that happen. This endeavor also could set a large-scale precedent for returning something of value to participating research subjects: their own genetic data, along with one-to-one telecounseling, and referral to resources that can help them address the impact of their results.

NIH has awarded $4.6 million in initial funding to Color, a health technology company in Burlingame, California, to establish the program’s nationwide genetic counseling resource and provide the underlying technology. Insights into the model being used in this initiative could be helpful to health systems attempting to scale their own innovations and disseminate information to a large group of participants.

All of Us Background
 

With the goal of speeding up health research breakthroughs, All of Us plans to sequence the genomes of 1 million participants from diverse communities across the United States, and is seeking to add data from populations typically underrepresented in genomic research.

An article previously published in HealthLeaders revealed that All of Us received funding from the National Institutes of Health in 2016 and began enrolling participants in 2018. As of July 2019, biospecimens had been collected from 175,000 people. So far, more than 80% of participants are from groups that have been underrepresented in biomedical research.

Technology Built to Scale
 

"Color has built a full software and technology stack to support the return of genetic results to large populations," says Alicia Zhou, PhD, vice president of research and scientific affairs for Color.

The technology platform is designed to provide maximum efficiency, says Color CEO Othman Laraki.

"The automation in the system enables the genetic counselor to focus on the human touch and answering the direct questions of patients," he says, "That is a very big part of enabling us to both scale more efficiently, and also provide a higher quality service."

Once participants receive notice that their results are available, they can log into the system via a mobile device or computer, and schedule a genetic counseling session. Via a teleconsult, the counselor will review the results, which the participant will then be able to access online with through a web-based interactive format, download a PDF file, or receive written results via mail.

Addressing Continuity of Care and Referrals
 

The technology also supports the referral process. Counselors will refer individuals to local or regional physicians and specialists, who are affiliated with the 40-plus health systems and hospitals across the country participating in the program, as well as health center pilot sites and select medical centers in the U.S. Department of Veterans Affairs. Some of the participating health systems include:

  • Banner Health System in Phoenix
  • Columbia University Medical Center in New York City
  • Henry Ford Health System in Detroit
  • Partners HealthCare System in Boston
  • University of California San Diego

In addition, individuals may be referred to other resources, such as support groups or advocacy organizations.

The referral component is essential to the process, says Laraki. "One of the biggest challenges in healthcare, in general, is the continuity of care," he says. "Genetic testing is one of the places where there are very challenging handoffs at times, where people get lost in the shuffle. [Color offers] an integrated end-to-end system built on top of the technology stack that enables us to provide these services in a very scalable way."

Maximum Efficiency Enables Counselors to Focus on Patients
 

"This is an opportunity for us to help participants engage with their genetic information, says Lauren Ryan, MS, LCGC, head of clinical counseling services for Color. The counselor will explain the findings and implications for the individual's health, as well as for family members who may be impacted by the same genetic data. The subjects also may receive published recommendations so they can develop a plan with their doctor "to actually achieve better health with this information and be able to take action on it," she says.

All of Color's genetic counselors are board certified and licensed in the states where they provide services, Ryan says. Their background typically includes a master's degree in genetic counseling and board certification. Some states also require licensure.

Delivering Value to Research Participants
 

“Returning results in a responsible way is integral to what All of Us stands for,” said All of Us Director Eric Dishman in a news release. “Participants are our partners in research, who may want to receive their own health data, including genomics. The genetic counseling resource will help our participants interpret and act upon their health information.”

Color's CEO says that this approach is novel.

"We believe that it's going to set a major precedent both in how large-scale research is conducted through the return of results to all participants … and in using technology for large-scale care delivery," says Laraki. "Taking on the ambitious task of doing genetic counseling for a million people across all 50 states without relying on any physical infrastructure is a very bold move. And we think that's going to end up influencing the entire field for a long time."

 

Mandy Roth is the innovations editor at HealthLeaders.


KEY TAKEAWAYS

Conducting genetic counseling for a million people across 50 states with no physical infrastructure "is a very bold move."

Process may set precedents for returning information of value to research participants and large-scale data delivery.

Technology platform expedites data processing and referral process; and solution includes telehealth consultations.


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