EMR Outcomes: Anxiety and Depression in Epilepsy

Study Overview
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Brief Summary
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The purpose of this research is to find out how people with epilepsy and possible symptoms of anxiety or depression are doing for 6 months after a regular epilepsy clinic visit. Participants in this study will complete questionnaires either by phone or via the patient portal.

Detailed Description
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This is a study among N=30 individuals with epilepsy and high or borderline anxiety or depression symptoms receiving usual care at the Wake Forest Comprehensive Epilepsy Center. Participants are randomized to one of two outcome assessment methods [Electronic Medical Record (EMR)-based-interventional method vs. telephone-based-standard method] for collecting quality of life, anxiety and depression outcomes at 3 and 6 months, under usual care management. The primary aim of the study is to assess feasibility of EMR-based outcome assessment by measuring 6-month retention.

Official Title
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Anxiety and Depression in Epilepsy: Assessing Outcomes Using the Electronic Medical Record (EMR)

Conditions
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Quality of Life, Anxiety, Depression, Epilepsy

Intervention / Treatment
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* Other: EMR-based-interventional method
* Other: Telephone-based-standard method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Completed electronic questionnaires independently in clinic Epilepsy diagnosis (clinician impression or EEG-based) Borderline or high anxiety or depression symptoms at baseline GAD-7 score > 7 (anxiety) NDDI-E score > 13 (depression) Exclusion Criteria: Passive suicidal ideation (NDDI-E item 4 score of 3 or 4) Age <18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMR Group<br>Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. | Other: EMR-based-interventional method<br>* Questionnaire delivery method. Participants will complete standard care anxiety and depression screening and quality of life assessment directly into the patient entered section of the EMR, administered on arrival in the clinic.<br>|
| Active Comparator: Phone Group<br>Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. | Other: Telephone-based-standard method<br>* Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Retained in the Study in the EMR Arm | Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Retained in the Study in the Phone Arm | Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments via phone | 6 months | 
| Quality of Life in Epilepsy-10 (QOLIE-10) | QOLIE-10 is A brief questionnaire (10-items) to screen for quality of life in epilepsy. Total Score 0-100. Higher scores denotes worse outcomes. | Baseline | 
| Quality of Life in Epilepsy-10 (QOLIE-10) | QOLIE-10 is A brief questionnaire (10-items) to screen for quality of life in epilepsy. Total Score 0-100. Higher scores denotes worse outcomes. | 3 Months | 
| Quality of Life in Epilepsy-10 (QOLIE-10) | QOLIE-10 is A brief questionnaire (10-items) to screen for quality of life in epilepsy. Total Score 0-100. Higher scores denotes worse outcomes. | 6 Months | 
| Generalized Anxiety Disorder 7-item (GAD-7) Scale | Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. | Baseline | 
| Generalized Anxiety Disorder 7-item (GAD-7) Scale | Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. | 3 Months | 
| Generalized Anxiety Disorder 7-item (GAD-7) Scale | Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. | 6 months | 
| Neurological Disorders Depression Inventory (NDDI-E) | The NDDI-E is a 6-item questionnaire validated to screen for depression in people with epilepsy. Total Score 4-24. Higher scores denotes worse outcomes. | Baseline | 
| Neurological Disorders Depression Inventory (NDDI-E) | The NDDI-E is a 6-item questionnaire validated to screen for depression in people with epilepsy. Total Score 4-24. Higher scores denotes worse outcomes. | 3 Months | 
| Neurological Disorders Depression Inventory (NDDI-E) | The NDDI-E is a 6-item questionnaire validated to screen for depression in people with epilepsy. Total Score 4-24. Higher scores denotes worse outcomes. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic medical record, EMR, Patient Outcomes