EMR Outcomes: Anxiety and Depression in Epilepsy

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT03879525
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life; Anxiety; Depression; Epilepsy	Other: EMR-based-interventional method; Other: Telephone-based-standard method	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome group assignment will not be blinded to the primary investigator or primary study coordinator, as it will be necessary for these individuals to know outcome assessment allocation in order for outcome collection to occur. When possible, outcome group assignment will not be shared with the epilepsy provider managing the participant, in an effort to reduce any potential bias in retention that could be introduced by the provider in clinical interactions with the participant.
• Primary Purpose: Supportive Care
• Official Title: Anxiety and Depression in Epilepsy: Assessing Outcomes Using the Electronic Medical Record (EMR)
• Actual Study Start Date: Dec 16, 2019
• Actual Primary Completion Date: Nov 10, 2020
• Actual Study Completion Date: Sep 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EMR Group Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.	Other: EMR-based-interventional method; 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.
Active Comparator: Phone Group Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.	Other: Telephone-based-standard method; Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Retained in the Study in the EMR Arm [6 months]

   Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR

Secondary Outcome Measures

1. Percentage of Participants Retained in the Study in the Phone Arm [6 months]

   Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments via phone

2. Quality of Life in Epilepsy-10 (QOLIE-10) [Baseline]

   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. Quality of Life in Epilepsy-10 (QOLIE-10) [3 Months]

   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.

4. Quality of Life in Epilepsy-10 (QOLIE-10) [6 Months]

   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.

5. Generalized Anxiety Disorder 7-item (GAD-7) Scale [Baseline]

   Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.

6. Generalized Anxiety Disorder 7-item (GAD-7) Scale [3 Months]

   Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.

7. Generalized Anxiety Disorder 7-item (GAD-7) Scale [6 months]

   Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.

8. Neurological Disorders Depression Inventory (NDDI-E) [Baseline]

   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.

9. Neurological Disorders Depression Inventory (NDDI-E) [3 Months]

   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.

10. Neurological Disorders Depression Inventory (NDDI-E) [6 Months]

    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.

Other Outcome Measures

1. Semi-Structured Interviews [13 Months]

   Optional semi-structured interviews to assess patient-level barriers and facilitators to successfully implementing a collaborative care model of mental health care. Data will be analyzed via an inductive thematic analysis approach.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Heidi M. Munger Clary, MD, MPH, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 3, 2020
• Informed Consent Form - Feb 19, 2020

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03879525
• Other Study ID Numbers: IRB00056740
• First Posted: Mar 18, 2019
• Last Update Posted: Jan 18, 2022
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: Electronic medical record; EMR; Patient Outcomes
• Additional relevant MeSH terms: Epilepsy; Depression; Depressive Disorder; Anxiety Disorders

Study Results

Participant Flow

Arm/Group Title	EMR Group	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the Electronic Medical Record (EMR) using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	EMR Group	Phone Group	Total
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.5 (13.4)	42.5 (12.7)	42.5 (12.8)
Sex: Female, Male (Count of Participants)
Female	7 46.7%	11 73.3%	18 60%
Male	8 53.3%	4 26.7%	12 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	15 100%	15 100%	30 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 6.7%	0 0%	1 3.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 20%	2 13.3%	5 16.7%
White	11 73.3%	12 80%	23 76.7%
More than one race	0 0%	1 6.7%	1 3.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This outcome pertains only to EMR group; phone group is analyzed in separate outcome.

Arm/Group Title	EMR Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.
Measure Participants	15
Number [percentage of participants]	67 446.7%

2. Secondary Outcome

Title	Percentage of Participants Retained in the Study in the Phone Arm
Description	Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments via phone
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

This outcome pertains only to the phone group; EMR group was analyzed in a different outcome.

Arm/Group Title	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Measure Participants	15
Number [percentage of participants]	100 666.7%

3. Secondary Outcome

Title	Quality of Life in Epilepsy-10 (QOLIE-10)
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EMR Group	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	53.3 (16.6)	60.5 (18.6)

4. Secondary Outcome

Title	Quality of Life in Epilepsy-10 (QOLIE-10)
Description	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.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

5 individuals in EMR arm did not return the 3 month outcome assessment

Arm/Group Title	EMR Group	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Measure Participants	10	15
Mean (Standard Deviation) [score on a scale]	61.0 (18.6)	57.3 (15.7)

5. Secondary Outcome

Title	Quality of Life in Epilepsy-10 (QOLIE-10)
Description	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.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EMR Group	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	57.6 (20.3)	62.6 (16.7)

6. Secondary Outcome

Title	Generalized Anxiety Disorder 7-item (GAD-7) Scale
Description	Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EMR Group	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	10.5 (5.3)	10.5 (3.8)

7. Secondary Outcome

Title	Generalized Anxiety Disorder 7-item (GAD-7) Scale
Description	Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

5 individuals in EMR arm did not return the 3 month outcome assessment

Arm/Group Title	EMR Group	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Measure Participants	10	15
Mean (Standard Deviation) [score on a scale]	6.0 (3.0)	10.2 (4.2)

8. Secondary Outcome

Title	Generalized Anxiety Disorder 7-item (GAD-7) Scale
Description	Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EMR Group	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	7.7 (5.4)	8.5 (5.0)

9. Secondary Outcome

Title	Neurological Disorders Depression Inventory (NDDI-E)
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EMR Group	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	15.4 (2.8)	15.3 (3.4)

10. Secondary Outcome

Title	Neurological Disorders Depression Inventory (NDDI-E)
Description	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.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

5 individuals in EMR arm did not return the 3 month outcome assessment

Arm/Group Title	EMR Group	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Measure Participants	10	15
Mean (Standard Deviation) [score on a scale]	15.4 (3.1)	15.0 (2.6)

11. Secondary Outcome

Title	Neurological Disorders Depression Inventory (NDDI-E)
Description	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.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EMR Group	Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.	Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	14.7 (3.9)	13.8 (3.4)

12. Other Pre-specified Outcome

Title	Semi-Structured Interviews
Description	Optional semi-structured interviews to assess patient-level barriers and facilitators to successfully implementing a collaborative care model of mental health care. Data will be analyzed via an inductive thematic analysis approach.
Time Frame	13 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Baseline through 6 month follow up
Arm/Group Title	EMR Group		Phone Group
Arm/Group Description	Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. EMR-based-interventional method: 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.		Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
All Cause Mortality
	EMR Group		Phone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	EMR Group		Phone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/15 (13.3%)		0/15 (0%)
Nervous system disorders
status epilepticus	2/15 (13.3%)	2	0/15 (0%)	0
Other (Not Including Serious) Adverse Events
	EMR Group		Phone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.