Epilepsy
Conditions
Keywords
anxiety, depression, screening tools
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.
Interventions
BEHAVIORALScreening Questionnaires
Standard care screening questionnaires on anxiety and depression
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Completing Screening Instruments | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Percent Accuracy of Kit Application Programming Interface (API) | Week 1 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Clinic Visit Attendance:Visit Completed | Week 1 | Number of visits completed out of number scheduled |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Text Message Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression | 221 |
| 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.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression | 221 |
| Generic Electronic Health Record (EHR) Portal Email Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression | 219 |
| 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.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression | 219 |
| Total | 880 |
Baseline characteristics
| Characteristic | Total | EHR Portal With No Message | Generic Electronic Health Record (EHR) Portal Email | Customized Email Prompt | Text Message |
|---|---|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 17.2 | 41.2 years STANDARD_DEVIATION 17.1 | 45.3 years STANDARD_DEVIATION 18.1 | 42.3 years STANDARD_DEVIATION 16.6 | 42.2 years STANDARD_DEVIATION 16.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants | 16 Participants | 11 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 824 Participants | 200 Participants | 205 Participants | 206 Participants | 213 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 172 Participants | 38 Participants | 47 Participants | 49 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 54 Participants | 20 Participants | 12 Participants | 14 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 643 Participants | 158 Participants | 157 Participants | 155 Participants | 173 Participants |
| Sex/Gender, Customized female | 488 Participants | 118 Participants | 126 Participants | 116 Participants | 128 Participants |
| Sex/Gender, Customized male | 389 Participants | 100 Participants | 93 Participants | 103 Participants | 93 Participants |
| Sex/Gender, Customized unknown | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 221 | 0 / 221 | 0 / 219 | 0 / 219 |
| other Total, other adverse events | 0 / 221 | 0 / 221 | 0 / 219 | 0 / 219 |
| serious Total, serious adverse events | 0 / 221 | 0 / 221 | 0 / 219 | 0 / 219 |
Outcome results
Primary
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.
Time frame: Week 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Text Message | Percentage of Subjects Completing Screening Instruments | 0 Percentage who completed |
| Customized Email Prompt | Percentage of Subjects Completing Screening Instruments | 14 Percentage who completed |
| Generic Electronic Health Record (EHR) Portal Email | Percentage of Subjects Completing Screening Instruments | 19 Percentage who completed |
| EHR Portal With No Message | Percentage of Subjects Completing Screening Instruments | 12 Percentage who completed |
Secondary
Participant Time From Instrument Delivery to Completion
Time in minutes will be recorded
Time frame: Week 1
Population: no responses received due to technical error in text delivery occurring outside of REDCap text sending interface - number of participants with instrument responses received - number of participants with instrument responses received - number of participants with instrument responses received
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Customized Email Prompt | Participant Time From Instrument Delivery to Completion | 4.6 minutes | Standard Deviation 2.4 |
| Generic Electronic Health Record (EHR) Portal Email | Participant Time From Instrument Delivery to Completion | 3.1 minutes | Standard Deviation 2.6 |
| EHR Portal With No Message | Participant Time From Instrument Delivery to Completion | 2.2 minutes | Standard Deviation 2.1 |
Secondary
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.
Time frame: Week 1
Population: The analysis population for this outcome measure (accuracy of Kit API) is only participants randomized to one of the two EHR portal arms who also completed the pre-visit questionnaires and thus had questionnaires completed in the electronic health record available for testing Kit API data collection accuracy, as this tool is designed to collect data directly from the health record into REDCap.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Generic Electronic Health Record (EHR) Portal Email | Percent Accuracy of Kit Application Programming Interface (API) | 100 percent scores identical to EHR source |
| EHR Portal With No Message | Percent Accuracy of Kit Application Programming Interface (API) | 100 percent scores identical to EHR source |
Secondary
Research Team Time-instrument Data Entry
Time in minutes will be recorded
Time frame: Week 1
Population: no responses received in Text Message Arm due to technical error in text delivery occurring outside of REDCap text sending interface
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Customized Email Prompt | Research Team Time-instrument Data Entry | 2.5 minutes | Standard Deviation 2 |
| Generic Electronic Health Record (EHR) Portal Email | Research Team Time-instrument Data Entry | 1.8 minutes | Standard Deviation 2 |
| EHR Portal With No Message | Research Team Time-instrument Data Entry | 1.7 minutes | Standard Deviation 2.4 |
Secondary
Research Team Time-sending Instruments
Time in minutes will be recorded
Time frame: Baseline Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Text Message | Research Team Time-sending Instruments | 3.0 minutes | Standard Deviation 1.6 |
| Customized Email Prompt | Research Team Time-sending Instruments | 4.5 minutes | Standard Deviation 1.8 |
| Generic Electronic Health Record (EHR) Portal Email | Research Team Time-sending Instruments | 1.7 minutes | Standard Deviation 1.2 |
| EHR Portal With No Message | Research Team Time-sending Instruments | 0.6 minutes | Standard Deviation 0.6 |
Other Pre-specified
Clinic Visit Attendance: No-show
Number of no-show visits out of number scheduled
Time frame: Week 1
Other Pre-specified
Clinic Visit Attendance:Visit Canceled
Number of visits completed out of number scheduled
Time frame: Week 1
Other Pre-specified
Clinic Visit Attendance:Visit Completed
Number of visits completed out of number scheduled
Time frame: Week 1
Other Pre-specified
Time For Data Entry
Time collected in minutes
Time frame: Week 1