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| ID | Type | Description | Link |
|---|---|---|---|
| R03TR004251 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening Questionnaires | Behavioral | Standard care screening questionnaires on anxiety and depression |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Research Team Time-sending Instruments | Time in minutes will be recorded | Baseline Day 0 |
| Research Team Time-instrument Data Entry | Time in minutes will be recorded |
| Measure | Description | Time Frame |
|---|---|---|
| Clinic Visit Attendance:Visit Completed | Number of visits completed out of number scheduled | Week 1 |
| Clinic Visit Attendance:Visit Canceled | Number of visits completed out of number scheduled |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi M. Munger Clary, MD, MPH | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
After the study is completed and results published by primary study team, de-identified, archived data will be stored for potential use if requested by other qualified researchers including those outside of the study.
After the study is completed and results published, de-identified, archived data will be available upon request.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | Electronic Health Record (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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Customized Email Prompt |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Percentage who completed | Week 1 |
|
Week 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heidi Munger-Clary, MD, MPH, FACNS, FAES | Wake Forest University Health Sciences | 336-716-7110 | heidi.mungerclary@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2024 | Jul 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 22, 2024 | Jul 7, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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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.
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| Week 1 |
| Participant Time From Instrument Delivery to Completion | Time in minutes will be recorded | Week 1 |
| 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. | Week 1 |
| Week 1 |
| Clinic Visit Attendance: No-show | Number of no-show visits out of number scheduled | Week 1 |
| Time For Data Entry | Time collected in minutes | Week 1 |
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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
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
| OG002 | 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 |
| OG003 | 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 |
|
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| Secondary | Research Team Time-sending Instruments | Time in minutes will be recorded | Posted | Mean | Standard Deviation | minutes | Baseline Day 0 |
|
|
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| Secondary | Research Team Time-instrument Data Entry | Time in minutes will be recorded | no responses received in Text Message Arm due to technical error in text delivery occurring outside of REDCap text sending interface | Posted | Mean | Standard Deviation | minutes | Week 1 |
|
|
|
| Secondary | Participant Time From Instrument Delivery to Completion | Time in minutes will be recorded | 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 | Posted | Mean | Standard Deviation | minutes | Week 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. | 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. | Posted | Mean | Full Range | percent scores identical to EHR source | Week 1 |
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| Other Pre-specified | Clinic Visit Attendance:Visit Completed | Number of visits completed out of number scheduled | Not Posted | Week 1 | Participants |
| Other Pre-specified | Clinic Visit Attendance:Visit Canceled | Number of visits completed out of number scheduled | Not Posted | Week 1 | Participants |
| Other Pre-specified | Clinic Visit Attendance: No-show | Number of no-show visits out of number scheduled | Not Posted | Week 1 | Participants |
| Other Pre-specified | Time For Data Entry | Time collected in minutes | Not Posted | Week 1 | Participants |
| 0 |
| 221 |
| 0 |
| 221 |
| 0 |
| 221 |
| EG001 | 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 | 0 | 221 | 0 | 221 | 0 | 221 |
| EG002 | 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 | 0 | 219 | 0 | 219 | 0 | 219 |
| EG003 | 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 | 0 | 219 | 0 | 219 | 0 | 219 |
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |