Tools for Anxiety and Depression Screening in Epilepsy

Developing Interoperable Tools for Anxiety and Depression Screening in Epilepsy

A randomized trial to compare patient-completion success of REDCap and Electronic Health Record (EHR)-based anxiety & depression instrument delivery methods. Study hypothesis is that the screening completion proportion will vary across the 4 modalities tested.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Screening Questionnaires

Detailed Description

In this randomized study of four modalities, we will compare Twilio text message delivery via REDCap versus (vs.) REDCap email survey links vs. EHR portal questionnaires with reminder message vs. current standard delivery EHR portal questionnaires without reminder. Screening instruments will be delivered by randomized method 7 days prior to scheduled clinic visit and outcomes occur by the time of the scheduled clinic visit. The study setting is the Wake Forest Comprehensive Epilepsy Center, with 2 clinic sites where adult patients are served (Atrium Health Wake Forest Baptist main campus, Atrium Health High Point Medical Center). EHR portal questionnaires without reminder is the current standard care screener delivery method. An exploratory supplement randomizing individuals to text message versus email survey link was later added.

• Study Type: Interventional
• Enrollment (Actual): 880
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Visit scheduled 7 days in advance at an adult-focused epilepsy clinic at the study site

Exclusion Criteria:

• No exclusions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Text Message; Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.	Behavioral: Screening Questionnaires; Standard care screening questionnaires on anxiety and depression
Active Comparator: Customized Email Prompt; Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by an email with a REDCap email survey link.	Behavioral: Screening Questionnaires; Standard care screening questionnaires on anxiety and depression
Active Comparator: Generic Electronic Health Record (EHR) portal email; Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.	Behavioral: Screening Questionnaires; Standard care screening questionnaires on anxiety and depression
Active Comparator: EHR Portal with No Message; Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.	Behavioral: Screening Questionnaires; Standard care screening questionnaires on anxiety and depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Completing Screening Instruments	Percentage of subjects completing screening instruments by each of the 4 methods prior to clinic visit will be used to compare the effect of the different methods on patient self-completion, and to estimate completion rates by different methods for use in future screening implementation trials.	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Research Team Time-sending Instruments	Time in minutes will be recorded	Baseline Day 0
Research Team Time-instrument Data Entry	Time in minutes will be recorded	Week 1
Participant Time From Instrument Delivery to Completion	Time in minutes will be recorded	Week 1
Percent Accuracy of Kit Application Programming Interface (API)	Among participants who completed anxiety and depression screening instruments by one of the two EHR methods, this measure evaluates the % of instrument scores collected via Kit API that were identical to the original EHR source completion.	Week 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time For Data Entry	Time collected in minutes	Week 1
Clinic Visit Attendance:Visit Completed	Number of visits completed out of number scheduled	Week 1
Clinic Visit Attendance:Visit Canceled	Number of visits completed out of number scheduled	Week 1
Clinic Visit Attendance: No-show	Number of no-show visits out of number scheduled	Week 1

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Heidi M. Munger Clary, MD, MPH, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Actual): September 3, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: depression; anxiety; screening tools
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Epilepsy
• Other Study ID Numbers: IRB00086172; R03TR004251 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study is completed and results published by primary study team, de-identified, archived data will be stored for potential use if requested by other qualified researchers including those outside of the study.
• IPD Sharing Time Frame: After the study is completed and results published, de-identified, archived data will be available upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No