DOI: 10.5061/dryad.qz612jmk3
title: 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

description: Objective: To close gaps between research and clinical practice, tools are
 needed for efficient pragmatic trial recruitment and patient-reported
 outcome(PROM) 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. Results: Participants 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 minutes 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: Data from this randomized pilot study of pragmatic outcome
 collection methods for patients with anxiety or depression symptoms in
 epilepsy includes baseline participant characteristics, recruitment flow
 resulting from a novel EHR-based, care-embedded recruitment process, and
 data on retention along with various process measures at 6-months.
description: 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.