This README.md file was generated on 2022-10-23 by Heidi Munger Clary GENERAL INFORMATION 1. Title of Dataset: 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 2. Author Information A. Principal Investigator Contact Information Name: Munger Clary, Heidi Institution: Wake Forest University School of Medicine (Wake Forest Baptist Medical Center) Address: 1 Medical Center Blvd. Winston-Salem, NC 27157 Email: hmungerc@wakehealth.edu B. Associate or Co-investigator Contact Information Name: Snively, Beverly M Institution: Wake Forest University School of Medicine (Wake Forest Baptist Medical Center) Address: Department of Biostatistics and Data Science, 1 Medical Center Blvd. Winston-Salem, NC 27157 Email: bmellen@wakehealth.edu 3. Date of data collection (single date, range, approximate date): 2019-12-12 to 2021-10-28 4. Geographic location of data collection: Winston-Salem, North Carolina 5. Information about funding sources that supported the collection of the data: NIH: NCATS grants KL2 TR001421, UL1 TR001420 SHARING/ACCESS INFORMATION 1. Licenses/restrictions placed on the data: none DATA & FILE OVERVIEW 1. File List: flowdiag 10-23-22.csv aggregate dataset of recruitment information included in flow manuscript flow diagram main 10-5-2022.csv main dataset for enrolled participants at baseline and at 3- and 6-month follow ups screen 10-5-2022.csv dataset including those who completed electronic health record screening consent questionnaire based on potential eligibility 2. Relationship between files, if important: flowdiag is aggregate data encompassing all individuals and visits considered in the potential study eligibility, hmc_dryad_20220922.csv is limited individualized data from electronic health record among those who completed screening consent question; hmc_dryad_20220825.csv is the main dataset among enrolled participants 3. Additional related data collected that was not included in the current data package: 3- and 6-month quality of life, anxiety & depression measures; electronic health record-based and participant report healthcare utilization; clinical care plan for anxiety & depression at baseline 4. Are there multiple versions of the dataset? no METHODOLOGICAL INFORMATION 1. Description of methods used for collection/generation of data: https://clinicaltrials.gov/ProvidedDocs/25/NCT03879525/Prot_SAP_001.pdf 2. Methods for processing the data: 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. DATA-SPECIFIC INFORMATION FOR: flowdiag 10-23-22.csv 1. Number of variables: 29 2. Number of cases/rows: 18 3. Variable List: Group_id, identifier for unique groups in this dataset N_individuals, number of individual patients N_visits, number of separate clinic visits eligible, eligible for randomized study? (n=no y=yes) enrolled, enrolled in randomized study? (n=no y=yes) EHR, randomized to EHR arm? (n=no y=yes) randomized, participant randomized in the study? (n=no y=yes) followed-up, followed-up in the randomized study? (n=no y=yes) analyzed, data analyzed in the randomized study? (n=no y=yes) phone, randomized to the phone arm? (n=no y=yes) declined, declined to participate in the study after phone contact? (n=no y=yes) contacted, fully contacted by phone to offer study information and determine enrollment interest? (n=no y=yes) unable_contact, unable to reach by phone for consent? (n=no y=yes) brief_contact, brief initial phone contact but unable to re-contact for consent? (n=no y=yes) contact_attempt, attempted to contact by phone for consent? (n=no y=yes) nocontact_studyfull, no attempt to contact by phone because study already met enrollment? (n=no y=yes) no_epilepsy, ineligible due to lack of epilepsy diagnosis? (n=no y=yes) EHR_alert, EHR alert triggered due to potential eligibility? (n=no y=yes) notrigger_alert, no EHR alert due to lack of triggering action but potentially eligible? (n=no y=yes) suicidal, ineligible due to positive passive suicidality screen? (n=no y=yes) study_interest, agreed to study team phone contact on EHR screening consent? (n=no y=yes) nointerest_question, did not receive screening consent in EHR though did have symptoms? (n=no y=yes) interest_blank, no response to study contact question on screening consent? (n=no y=yes) low_symptoms, ineligible due to low screening scores? (n=no y=yes) high_symptoms, symptom score(s) in eligible range? (n=no y=yes) highsymptomvisit_then_lowsymptomvisit, two visits during study with first high symptoms then low symptoms? (n=no y=yes) nocontact_prior attempt, no contact because of prior attempt to contact from an earlier visit? (n=no y=yes) age<18, excluded due to age <18? (n=no y=yes) notes_exceptions, notes regarding exceptions to the group rows 4. Missing data codes: missing values were coded as NA 5. Specialized formats or other abbreviations used: EHR=electronic health record DATA-SPECIFIC INFORMATION FOR: main 10-5-2022.csv 1. Number of variables: 18 2. Number of cases/rows: 30 cases, 90 rows 3. Variable List: id, participant identifier redcap_event_name, indicator for timing of data collection: baseline/screening or a follow up visit, ('screening' '3 month outcomes' '6 month outcomes') arm, randomized study arm, ('1 electronic health record' '2 telephone') age_baseline_3grp, age category at baseline, ('1 20-34 years' '2 35-49 years' '3 50-64 years') gender, participan gender, ('Male' 'Female') non_hispanic_white_only, race/ethnicity non-hispanic white? ('0 no' '1 yes') education_3grp, education level, ('1 High school/GED or less' '2 Some college' '3 Bachelors degree or greater') epilepsy_type, type of epilepsy, ('Focal' 'Generalized' 'Unknown') seiz_free, seizure free? ('No' 'Yes') count_aedmed_amg27, number of current antiseizure medications at baseline gad7_score, GAD-7 scale score nddie_score, NDDI-E scale score outcome_data, outcome data ultimately collected via randomized or hybrid method of collection? ('No' 'Yes') retention, outcome data collected via randomized method? ('No' 'Yes') collecttime, staff time required to collect data entercollecttime, staff time required to collect and enter data in database num_reminders_num, number of reminders sent for data collection collection_vs_duedate_days, number of days after due-date that outcome data was collected 4. Missing data codes: missing values were coded as NA 5. Specialized formats or other abbreviations used: GAD-7=Generalized anxiety disorder-7; NDDI-E=Neurological Disorders Depression Inventory-Epilepsy DATA-SPECIFIC INFORMATION FOR: screen 10-5-2022.csv 1. Number of variables: 6 2. Number of cases/rows: 106 3. Variable List: QUEST_ANSWER, response to screening consent ('No' 'Yes') Randomized, considered for enrollment based on study team notification in EHR of interest and potential eligibility and ether randomized or not ('0=potentially eligible and interesed by EHR algorithm but did not enroll' '1=enrolled and randomized') ENCOUNTER_AGE, age at time of clinic visit encounter when assessed for eligibility emr_gad7, GAD-7 scale score emr_nddie, NDDI-E scale score emr_nddie4_coded, response to passive suicidal ideation question of the NDDI-E ('1=never' '2=rarely' '3=sometimes' '4=always or often') 4. Missing data codes: missing values were coded as NA 5. Specialized formats or other abbreviations used: GAD-7=Generalized anxiety disorder-7; NDDI-E=Neurological Disorders Depression Inventory-Epilepsy