Patient-reported outcomes via electronic health record portal vs. telephone: process and retention data in a pilot trial of anxiety or depression symptoms in epilepsy

The dataset was collected via a combination of the following: 1. manual extraction of EHR-based data followed by entry into REDCap and then analysis and further processing in SAS 9.4; 2. Data pull of Epic EHR-based data from Clarity database using standard programming techniques, followed by processing in SAS 9.4 and merging with data from REDCap; 3. Collection of data directly from participants via telephone with entry into REDCap and further processing in SAS 9.4; 4. Collection of process measures from study team tracking records followed by entry into REDCap and further processing in SAS 9.4. One file in the dataset contains aggregate data generated following merging of Clarity data pull-origin dataset with a REDCap dataset and further manual processing. Recruitment for the randomized trial began at an epilepsy clinic visit, with EHR-embedded validated anxiety and depression instruments, followed by automated EHR-based research screening consent and eligibility assessment. Fully eligible individuals later completed telephone consent, enrollment and randomization. Thirty total participants were randomized 1:1 to EHR portal versus telephone outcome assessment, and patient-reported and process outcomes were collected at 3- and 6-months, with primary outcome 6-month retention in EHR arm(feasibility target: ≥11 participants retained). Variables in this dataset include recruitment flow diagram data, baseline participant sociodemographic and clinical characteristics, retention (successful PROM collection at 6 months), and process measures. The process measures included research staff time to collect outcomes, research staff time to collect outcomes and enter data, time from initial outcome collection reminder to outcome collection, and number of reminders sent to participants for outcome collection. PROMs were collected via the randomized method only at 3 months. At 6 months, if the criteria for retention was not met by the randomized method (failure to return outcomes by 1 week after 5 post-due date reminders for outcome collection), up to 3 additional attempts were made to collect outcomes by the alternative method, and process measures were also collected during this hybrid outcome collection method approach.