Project Summary In the 50 years since the genetic counseling profession began, a systematic study of genetic counseling (GC) processes and outcomes in real-life sessions across specialties has never been conducted. In order to optimize GC quality and improve efficiency of care, the field must first be able to accurately and comprehensively measure GC processes and determine which processes are most critical to achieve positive patient experiences and outcomes. The overarching objective of this study is to characterize GC processes using a novel and pragmatic measure and to link variations in processes and session time to patient-reported outcomes using a rigorous approach to define quality, efficient GC in practice. The central hypothesis is that GC processes impact patient outcomes in complex ways and that by evaluating and linking processes with outcomes we can identify ways to optimize GC quality and efficiency. To test the central hypothesis and attain the overall objective, a reliable, pragmatic checklist will be used to measure GC processes in audio recorded sessions and to characterize the extent and types of variability in GC processes across genetic counselors and specialties using actual patient sessions of varying lengths. Surveys will measure patient experience, empowerment, activation, decisional and informational needs and information overload. Coincidence analysis will be conducted to identify patterns of GC processes that consistently make a difference for high scores on each patient-reported measure. Comparison of the extent to which characteristics of GC sessions (including time) influence variability in the processes used and variability in patient outcomes will be accomplished through random effects multilevel models. We will then test the effectiveness of a GC efficiency intervention that tailors counseling to a patients’ informational preferences and values assessments and removes select processes found not to contribute to differences in patient outcomes using a stepped-wedge randomized controlled study. The study will integrate perspectives from four community advisory boards and a genetic counselor advisory board to provide vital input throughout the study process. This participatory approach was chosen to leverage diverse perspectives to create research that is feasible, acceptable, and usable beyond the research environment. The results of this study will be useful in considering which GC processes are essential for optimizing various patient outcomes in minimal time for a diversity of patients. This study is expected to improve measurement of GC processes, more clearly delineate differences in genetic counseling processes and patient reported outcomes, and increase genetic counseling efficiency by reducing in person visit times while maintaining or improving quality patient outcomes.