PROJECT SUMMARY/ABSTRACT Ambulatory adverse drug events (ADEs) occur in 25% of new prescriptions and cause an estimated 4.5 million office visits and 100,000 hospitalizations per year, with patients from vulnerable populations experiencing higher rates of ADEs. Patients and caregivers are responsible for medication self-management and observe ADEs in the home and community, but are not engaged in detecting or reporting ADEs to ambulatory care teams. The objective of this proposal is to fill this gap by developing a stakeholder-designed tool for patient- initiated ADE reporting. Aim 1 utilizes natural language processing (NLP) to identify patient, caregiver and healthcare team contributory causes identified in ADE reports from a multistate Patient Safety Organization. Aim 2 employs user-centered design to develop and conduct feasibility testing of a prototype text messaging- based patient-initiated ADE reporting system, working with patients, caregivers and primary care personnel from the public health safety net, targeting factors identified in Aim 1. This tool will be adapted from an inpatient text-messaging tool and adapted specifically for low-health literacy primary care patients. Candidate Anjana Sharma, MD, MAS, is Assistant Professor of Family & Community Medicine at the University of California, San Francisco (UCSF). She has expertise in mixed methods and observational research studying patient engagement in quality and safety for vulnerable populations. In this proposal, Dr. Sharma seeks to build skills in natural language processing, user-centered design for low-health-literacy populations, and intervention development to enable her to design a patient-initiated ADE reporting tool. Dr. Sharma has assembled a skilled mentorship team, led by ambulatory patient quality and safety expert Dr. Urmimala Sarkar, including NLP expert Dr. Atul Butte, user-centered design expert Dr. Courtney Lyles, and primary care leader Dr. Kevin Grumbach. The career development plan benefits from the extensive resources available at UCSF and substantial material and methodologic support from the Department of Family & Community Medicine. This proposal is significant because it expands the limited knowledge base about harms from high-risk medications occurring in ambulatory care, and develops a novel means to measure ambulatory ADEs through patient- initiated reports. The work is aligned with Agency for Healthcare Research and Quality's priority areas of medication safety, ambulatory safety, and patient engagement. Aim 2 focuses on AHRQ priority populations of urban, low-income and ethnic minority populations. The skills and findings from this proposal will translate into an R-level proposal for a randomized trial of the patient-initiated ADE reporting tool in a safety-net primary care network. The proposed career development will advance Dr. Sharma toward her goals of research independence, expertise in developing interventions that engage patients and family c...