MedPath

Tools for Anxiety and Depression Screening in Epilepsy

Not Applicable
Active, not recruiting
Conditions
Epilepsy
Interventions
Behavioral: Screening Questionnaires
Registration Number
NCT05864612
Lead Sponsor
Wake Forest University Health Sciences
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1322
Inclusion Criteria
  • Visit scheduled 7 days in advance at an adult-focused epilepsy clinic at the study site
Exclusion Criteria
  • No exclusions

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EHR Portal with No MessageScreening QuestionnairesSubjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
Customized Email PromptScreening QuestionnairesSubjects 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.
Text MessageScreening QuestionnairesSubjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Generic Electronic Health Record (EHR) portal emailScreening QuestionnairesSubjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Primary Outcome Measures
NameTimeMethod
Screening completion - Yes or NoWeek 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
NameTimeMethod
Research team time-sending instrumentsBaseline Day 0

Time in minutes will be recorded

Research team time-instrument data entryWeek 1

Time in minutes will be recorded

Participant time from instrument delivery to completionWeek 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.

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist

🇺🇸

Winston-Salem, North Carolina, United States

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