New technologies like mobile apps, smart homes, wearable fitness trackers, and social media are an important part of patient-centered outcomes research (PCOR). This type of PCOR is called “digital health” research and can be used in health promotion interventions including text messages reminding people to take their medicine, measuring how well people follow study requirements (such as an internet-connected medication dispenser), measuring study outcomes (such as home blood pressure results).
These powerful technologies can make studies cheaper to run, and less burdensome for participants. They make it possible to run very large studies that were not previously possible. However, these technologies also come with some risks. Potential risks may be related to device malfunctions or privacy risks related to personal health information. Sometimes risks can be identified and managed, but sometimes potential risks can be hard to identify and manage.
The proposed study will involve researchers and regulatory experts involved with research participant safety and well-being (Aim 1). These researchers will evaluate a risk management tool. The goal is for this risk management tool to help identify digital health research risks and benefits and to better manage risks.
Plus, patients will help the team create an informed consent process that will better explain digital health information. Informed consent is the basis of ethical research, but to provide consent, patients need to know enough about the technology and personal data collected to make an informed choice to participate or not participate. Patients must know what information is being shared as well as when and how that information should be delivered. Patients will help the team design consent processes that may lead to better informed consent in digital health PCOR (Aim2).
Sponsored research should lead to a product’s adoption and use. This research relies on dissemination and implementation to build the steps needed for adopting the study results. The team can increase the likelihood of wider adoption by careful thinking about how researchers, regulators, and patients might use its risk assessment/management and consent tools.
The team plans to work with digital health PCOR stakeholders to understand their challenges and most important outcomes. This research builds on earlier work to create decision support tools for researchers and to identify best practices for explaining informed consent and how to return research information to participants. This stakeholder-focused approach makes it possible for patients and researchers to work together to make digital health PCOR safer and more beneficial. Study results will give IRB reviewers more insight into participant protections, and more confident oversight of digital health PCOR studies.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.