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Clinical Trials/NCT05864612
NCT05864612CompletedNot Applicable

Developing Interoperable Tools for Anxiety and Depression Screening in Epilepsy

Wake Forest University Health Sciences1 site in 1 country880 target enrollmentStarted: September 20, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
880
Locations
1
Primary Endpoint
Percentage of Subjects Completing Screening Instruments

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •No exclusions

Arms & Interventions

Text Message

Active Comparator

Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.

Intervention: Screening Questionnaires (Behavioral)

Customized Email Prompt

Active Comparator

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.

Intervention: Screening Questionnaires (Behavioral)

Generic Electronic Health Record (EHR) portal email

Active Comparator

Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.

Intervention: Screening Questionnaires (Behavioral)

EHR Portal with No Message

Active Comparator

Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.

Intervention: Screening Questionnaires (Behavioral)

Outcomes

Primary Outcomes

Percentage of Subjects Completing Screening Instruments

Time Frame: Week 1

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.

Secondary Outcomes

  • Research Team Time-sending Instruments(Baseline Day 0)
  • Research Team Time-instrument Data Entry(Week 1)
  • Participant Time From Instrument Delivery to Completion(Week 1)
  • Percent Accuracy of Kit Application Programming Interface (API)(Week 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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