ResearchPass Puts Clinical Trial Information at Participants’ Fingertips
Developed by University of Miami Miller School of Medicine and Jackson Health System leaders, the digital wallet pass gives clinical trial participants mobile access to key study contacts and information.
Key Takeaways
- Clinical trial participants may receive care outside scheduled research visits, creating a need for quick access to accurate study information.
- ResearchPass allows participants to store key research details on their smartphones through Apple Wallet or Google Wallet.
- The tool was developed through the University of Miami Clinical and Translational Science Institute and the UM-Jackson Oneness initiative.
- Research teams can activate ResearchPass within REDCap, a platform already widely used for research management and participant engagement.
Clinical trial participants often receive care from multiple providers and health systems while enrolled in research studies. When questions arise about study medications, principal investigators or research protocols outside of scheduled study visits, obtaining accurate information quickly can be challenging for both participants and clinicians.
To address that challenge, leaders from the University of Miami Miller School of Medicine and Jackson Health System collaborated to create ResearchPass, a digital tool designed to place critical study information directly into participants’ smartphones.
What is ResearchPass?
ResearchPass is a digital wallet tool that allows clinical trial participants to store key study information on their smartphones and share it with health care providers, when needed. Available through Apple Wallet and Google Wallet, the pass provides participants with immediate access to research contacts and study information that can be critical when receiving care outside of routine research visits.
Developed through the University of Miami Clinical and Translational Science Institute (CTSI) and the UM-Jackson Oneness initiative, ResearchPass represents a broader effort to improve research participant safety, communication and autonomy while strengthening the connection between clinical care and clinical research.
Supporting Research Participants Beyond Study Visits
According to Erin Kobetz, M.D., M.P.H., multiple principal investigator and co-director of the CTSI, the project grew out of ongoing efforts to identify challenges that can affect both research participants and clinical teams.
“Our goal is to try to identify and help the research community overcome common impediments to translational progress,” said Dr. Kobetz, the associate director for community outreach and John K. and Judy H. Schulte Senior Endowed Chair in Cancer Research at Sylvester Comprehensive Cancer Center, part of the Miller School. “Something like ResearchPass is a solution that helps teams address challenges related to research participation.”
Dr. Kobetz believes ResearchPass addresses a longstanding need within the research enterprise.
“I think that we collectively have to continue to try to do a better job of equipping research participants with the information that they need,” she said. “Participant autonomy is a really important part of ensuring that the work that we do resonates with the people that it’s intended to serve.”
That emphasis on participant empowerment was shared by Katuzka Barbery, M.D., EMBA, director of clinical research for Jackson Health System’s Office of Research Administration, who noted that access to accurate study information can help support both patient care and research participation.
“If a clinician is unaware that a patient is in a clinical trial, they will not know how to treat a patient effectively, as there could be an interaction between the investigational product and clinical care medications,” Dr. Barbery said. “The other issue is the negative impact of medication interaction, which may decrease the investigational product effects leading to unfavorable results.”
Why This Research Matters
Clinical trial participants may receive care from multiple providers and health systems, including outside scheduled research visits. In those situations, clinicians and participants may need quick access to accurate study information.
ResearchPass allows participants to keep approved study contacts and principal investigator details on their smartphones through Apple Wallet or Google Wallet.
The configurable REDCap module is intended to support communication, participant access to information and coordination between clinical care and research.
How Does ResearchPass Work?
Turning the concept into reality involved Carlos Canales, the CTSI’s manager of business process analytics. Rather than building an entirely new system, Canales leveraged REDCap, a research platform already used extensively across the institution for study management, data collection and participant engagement.
“Pretty much all our researchers use REDCap,” Canales said.
“A lot of the research community, at UM and beyond, is really familiar with REDCap,” said Daru Lane Ransford, executive director of CTSI business operations. “We knew that positioning ResearchPass within that platform would make it accessible to the people we’re trying to reach.”
REDCap’s architecture necessitated relatively minor adjustments, work Canales did himself. Before submission to Apple and Google, the CTSI team worked closely with privacy, compliance and information technology specialists to ensure the tool met institutional requirements and protected participant information. Research teams can activate the module within REDCap and guide participants through the download process during study enrollment and consent activities.
Once enabled, the platform can generate a digital research participation card containing approved information, such as study contacts and principal investigator details. Participants can then download the pass to their smartphones for future reference.
“We wanted to create something that was for the community,” Canales said, adding that the development team anticipates future tweaking based on user feedback from study teams. “I think there’s room for improvement once we give it out to the research community.”
Extending Use Beyond Miami
Although ResearchPass has only recently become available, project leaders believe the concept has potential well beyond South Florida. The platform was designed as a configurable REDCap module rather than a proprietary product. Other institutions can adapt it to their own needs.
“Our plan is to also ideally present this to our national CTSI consortium so that we can train other hubs to establish it at their home institutions and make it available to their research teams,” Ransford said.
Research participants should have easy access to the information they need to navigate both their medical care and their research participation. By placing that information in a secure, mobile format, ResearchPass aims to improve clinical trial communication, support research participant safety and create a more participant-centered research experience.
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Tags: Clinical and Translational Science Institute, clinical trials, Dr. Erin Kobetz, Miami CTSI, technology