Tools for Anxiety and Depression Screening in Epilepsy

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05864612

Collaborator

National Center for Advancing Translational Sciences (NCATS) (NIH)

880

Enrollment

Location

Arms

Anticipated Duration (Months)

73.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Behavioral: Screening Questionnaires	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

880 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The four instrument delivery methods to be used in this pragmatic trial represent distinct prompts & cues for screening instrument completion. Examining these multiple instrument delivery methods will generate outputs that will support flexibility in instrument delivery modalities across multiple sites in future multicenter studies in this area. These 4 distinct delivery methods are used to deliver identical standard care validated anxiety and depression screening instruments.The four instrument delivery methods to be used in this pragmatic trial represent distinct prompts & cues for screening instrument completion. Examining these multiple instrument delivery methods will generate outputs that will support flexibility in instrument delivery modalities across multiple sites in future multicenter studies in this area. These 4 distinct delivery methods are used to deliver identical standard care validated anxiety and depression screening instruments.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Developing Interoperable Tools for Anxiety and Depression Screening in Epilepsy

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Screening completion - Yes or No [Week 1]
Proportion of screening instruments completed 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.

Secondary Outcome Measures

Research team time-sending instruments [Baseline Day 0]
Time in minutes will be recorded
Research team time-instrument data entry [Week 1]
Time in minutes will be recorded
Participant time from instrument delivery to completion [Week 1]
Time in minutes will be recorded
Accuracy of Kit Application Programming Interface (API) [Week 1]
This will provide key information about whether a Kit API REDCap data collection may improve accuracy of EHR-based data collection compared to manual collection.

Other Outcome Measures

Clinic visit attendance:Visit completed [Week 1]
Number of visits completed out of number scheduled
Clinic visit attendance:Visit canceled [Week 1]
Number of visits completed out of number scheduled
Clinic visit attendance: no-show [Week 1]
Number of no-show visits out of number scheduled
Time For Data Entry [Week 1]
Time collected in minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

No exclusions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

Wake Forest University Health Sciences
National Center for Advancing Translational Sciences (NCATS)

Investigators

Principal Investigator: Heidi M. Munger Clary, MD, MPH, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wake Forest University Health Sciences

ClinicalTrials.gov Identifier:

NCT05864612

Other Study ID Numbers:

IRB00086172
R03TR004251

First Posted:

May 18, 2023

Last Update Posted:

May 18, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wake Forest University Health Sciences

anxiety

depression

screening tools

Additional relevant MeSH terms:

Epilepsy

Depression

Study Results

No Results Posted as of May 18, 2023