Abstract
OBJECTIVE: To close gaps between research and clinical practice, tools are needed for efficient pragmatic trial recruitment and patient-reported outcome collection. The objective was to assess feasibility and process measures for patient-reported outcome collection in a randomized trial comparing electronic health record (EHR) patient portal questionnaires to telephone interview among adults with epilepsy and anxiety or depression symptoms. MATERIALS AND METHODS: 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. 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). RESULTS: Participants (N = 30) were 60% women, 77% White/non-Hispanic, with mean age 42.5 years. Among 15 individuals randomized to EHR portal, 10 (67%, CI 41.7%-84.8%) met the 6-month retention endpoint, versus 100% (CI 79.6%-100%) in the telephone group (P = 0.04). EHR outcome collection at 6 months required 11.8 min less research staff time per participant than telephone (5.9, CI 3.3-7.7 vs 17.7, CI 14.1-20.2). Subsequent telephone contact after unsuccessful EHR attempts enabled near complete data collection and still saved staff time. DISCUSSION: In this randomized study, EHR portal outcome assessment did not meet the retention feasibility target, but EHR method saved research staff time compared to telephone. CONCLUSION: While EHR portal outcome assessment was not feasible, hybrid EHR/telephone method was feasible and saved staff time.