Confidentiality {27}
Confidentiality will be protected by collecting only information needed to assess study outcomes, minimizing to the fullest extent possible the collection of any information that could directly identify patients, and maintaining all study information in a secure manner. To help ensure subject privacy and confidentiality, only a unique study identifier will appear in study datasets. An honest broker will mediate the electronic health record data queries to limit the exposure of patient identifying information. Planned analyses require full dates of visits (to determine the success of implementation over time), age, and 5-digit zip codes and GEOID (to determine rural or urban residency and ADI). Therefore, the honest broker will create a limited data set for analysis. The day that each clinic launches mPATH™ will be called day 0, with each subsequent or previous date recorded as an integer relative to day 0. This will add additional protections for patients by obscuring dates in the dataset. Any collected patient-identifying information corresponding to the unique study identifier will be maintained in a linkage file, stored separately from the data. The linkage file will be kept secure, with access limited to designated study personnel. Subject identifying information will be destroyed 3 years after the closure of the study, consistent with data validation and study design, producing an anonymous analytical data set. Data access will be limited to study staff. Data and records will be kept locked and secured, with any computer data password protected. No reference to any individual participant will appear in reports, presentations, or publications that may arise from the study.