Using Ethics and User-Centered Design to Create Templates for EHR-Mediated Return of Genetic Test Results

Patient engagement is critical for implementation of the genomic component of precision medicine--with care taken to include the perspectives and needs of patients. Yet many patients may experience significant barriers to understanding genetic information and/or using the electronic patient portals that many health systems are using to meet the terms of meaningful use related to the return of laboratory and test results. Although the return of genetic results and patient portal use have each received considerable attention, there have been few studies concerning the return of genetic test results via patient portals--even as more test results are made available to patients electronically. The success of precision medicine relies not only on algorithms behind clinical decision support and Big Data analytics but also on the activated patient: the patient who receives health-related information and is motivated and supported to act upon it. Prospective attention to practical and ethical concerns will help to ensure that patient perspectives are taken into account as developing technology is prepared for clinical deployment. The goal of the project is to define patient and key stakeholder needs, including those of patients from underrepresented populations, concerning the acceptability of receiving genetic test results electronically via a patient portal. The study will take place in the University of Washington Medicine (UW Medicine) system, which provides care for a diverse patient population in western Washington State through its network of hospital- and neighborhood-based clinics and uses Epic software's Electronic Health Record patient portal module. Specifically, the proposed investigation will: (1) explore with patients who have received genetic test results and non-genetic test results electronically their experience receiving those results and their views on their electronic return and how genetic results return differs, or does not differ, from non-genetic results; (2) expand the understanding of return of results thresholds by exploring with patient portal users who have received genetic test results how electronic return affects return thresholds and the nuances and challenges of presenting information for positive and negative results; and (3) following User-Centered Design principles, conduct cognitive interviews with portal users and non-users about the acceptability and ease of use of electronic return of results prototypes created using data from (1) and (2) with template options supporting use within and without the UW Medicine system. The proposed R21 exploratory research will provide preliminary data on patient perspectives across diverse populations on the use of patient portals to return genetic results electronically, including important work around thresholds for determining results that are appropriate for electronic delivery and developing report templates whose content is readily comprehensible and supports patient empowerment and enhances their engagement in their own health. PUBLIC HEALTH RELEVANCE: () The proposed research would provide preliminary, much-needed, timely data on patient perspectives across diverse populations on the use of patient portals to return genetic test results, including thresholds for determining results that are appropriate for electronic delivery and the content and presentation elements that diverse patients may require in order to benefit from genetic information delivered electronically. Research on patient values, needs, and preferences must be represented early--while issues are being explored and potential solutions identified--to ensure that the deployment of genomic medicine supports patient empowerment, enhances engagement, and does not contribute to healthcare delivery inequities.