Clinical trial NCT05864612: Tools for Anxiety and Depression Screening in Epilepsy
Official title: Developing Interoperable Tools for Anxiety and Depression Screening in Epilepsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: anxiety
depression
screening tools
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-05-18
Enrollment: 1322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The four instrument delivery methods to be used in this pragmatic trial represent distinct prompts \&amp; 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized trial to compare patient-completion success of REDCap and Electronic Health Record (EHR)-based anxiety \&amp; 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No exclusions

Primary outcomes:
measure: Screening completion - Yes or No
timeFrame: Week 1
Secondary outcomes:
measure: Research team time-sending instruments
timeFrame: Baseline Day 0
measure: Research team time-instrument data entry
timeFrame: Week 1
measure: Participant time from instrument delivery to completion
timeFrame: Week 1
measure: Accuracy of Kit Application Programming Interface (API)
timeFrame: Week 1
Other outcomes:
measure: Clinic visit attendance:Visit completed
timeFrame: Week 1
measure: Clinic visit attendance:Visit canceled
timeFrame: Week 1
measure: Clinic visit attendance: no-show
timeFrame: Week 1
measure: Time For Data Entry
timeFrame: Week 1
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi M. Munger Clary, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: