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This is a randomized effectiveness/implementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.
The intervention is a 24-week, evidence-based collaborative care model initiated around the time of a neurology visit. The collaborative care team roles include the care manager/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| collaborative care | Experimental | The collaborative care team roles include the care manager/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider. |
|
| usual neurology care | Active Comparator | Ongoing usual neurology care, without the addition of the collaborative care program - current standard care and is thus an ethically appropriate control condition for effectiveness and implementation trials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collaborative care | Behavioral | a 24-week neurology based collaborative care program consisting of: 1. a series of every 2 weeks care management calls by the care manager to evaluate anxiety, depression, seizures and side effects and deliver brief therapy interventions to the participant, and 2. collaborative care conferences including a psychiatrist to generate expert recommendations for anxiety and depression management and communication of recommendations between the care manger, psychiatrist and neurologist. |
| Measure | Description | Time Frame |
|---|---|---|
| change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups | adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants adhering to Intervention | adherence of intervention participants to the majority of care management - proportion of intervention group participants meeting minimum adherence metric of 50% call participation at 12 weeks | Week 12 |
| Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Generalized Anxiety Disorders- 7(GAD-7) Score between groups | Questionnaire measuring anxiety symptoms-score ranges from 0 to 21, with higher score indicating increased anxiety symptoms - proportion achieving 50% symptom reduction or remission by 6 months | Month 6 |
| Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) between groups |
Inclusion Criteria:
Exclusion Criteria:
For the third Aim (sustainability supplement: intervention only care delivery exploratory study supplement) - the Participants meeting the following criteria may participate
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren P Richmond | Contact | 336.716.9632 | Lauren.Richmond@Advocatehealth.org | |
| Heidi M Munger Clary, MD, MPH | Contact | 336-716-7110 | hmungerc@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heidi M Munger Clary, MPH | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | 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 results published by primary study team
Access to study data may be provided by the PI if requested by qualified investigators for individual participant data meta-analyses or potentially for other methodologically sound proposals.
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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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This is a randomized, single-blind hybrid effectiveness-implementation study of a neurology clinic-based 24-week collaborative care intervention versus usual neurology care among a total of 60 adults having epilepsy with anxiety and/or depression symptoms, during 6 months follow-up. Participants will be randomized in a 1:1 ratio to collaborative care intervention versus usual neurology care.
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The randomization table will be prepared by the study statistician, uploaded by the developer, and concealed from the PI and coordinators in the REDCap data management system until after consent, enrollment and baseline data collection is complete, to minimize bias - once participants are randomized it is just outcome assessor who is truly blinded
|
| usual neurology care | Behavioral | ongoing usual neurology care, without the addition of the collaborative care program |
|
adults with epilepsy and anxiety or depression symptoms - Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life |
| Month 6 |
| Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care | adults with epilepsy and anxiety or depression symptoms -- Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms | Month 6 |
| Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups | adults with epilepsy and anxiety or depression symptoms - The score was obtained by computing the sum of the scores obtained by items associated with it, from 0, "not at all", to 3, "nearly every day". The possible total score ranges from 0 to 54, with higher scores indicating worse anxiety symptoms | Month 6 |
Depression symptom questionnaire specifically for those with epilepsy-score ranges from 6 to 24, with a score >15 indicating presence of a likely major depressive episode. |
| Months 3 and 6 |
| Change in Patient Health Questionnaire-9 (PHQ-9) Score between groups | Score ranges from 0 to 27, with higher score indicating increased depression symptoms - proportion achieving 50% symptom reduction or remission by 6 months | Month 6 |
| Emergency Department (ED)/Hospitalization Visits | Number of hospitalizations or visits to ED. | Month 6 |
| Change in Liverpool Seizure Severity Scale (LSSS) between groups | Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity. | Month 6 |
| Seizure Frequency | Number of seizures experienced by participants - this will be change in seizure frequency and time since last seizure categories from baseline to 6 month follow-up: categorical rating scale developed by Epilepsy Learning Healthcare System & standardized in the American Academy of Neurology (AAN) seizure frequency quality measure | Month 6 |
| Number of Seizure medication adjustments | number of seizure medication adjustments to address side effects or lack of seizure control over 6 months | Month 6 |
| Feasibility of Intervention Measure (FIM) Subject Perspective | Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater feasibility | Baseline and Month 15 |
| Feasibility of Intervention Measure (FIM) Neurologist Perspective | Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater feasibility | Baseline and Month 15 |
| Acceptability of Intervention Measure (AIM) Subject Perspective | Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater acceptability | Baseline and Month 15 |
| Acceptability of Intervention Measure (AIM) Neurologist Perspective | Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater acceptability | Baseline and Month 15 |
| Intervention Appropriateness Measure (IAM) Subject Perspective | Questionnaire to help determine appropriateness of Collaborative Care from participants' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness | Baseline and Month 15 |
| Intervention Appropriateness Measure (IAM) Neurologist Perspective | Questionnaire to help determine appropriateness of Collaborative Care from Neurologists' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness | Baseline and Month 15 |
| Individual Participant Collaborative Care Call Attendance Percentage | Individual Participant Collaborative Care Call Attendance Percentage | Weeks 12 and 24 |
| change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups | adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state | Month 3 |
| change in brEASI (Brief anxiety in epilepsy survey instrument) | Scores of ≥7 on the Brief anxiety in epilepsy survey instrument (brEASI) indicate probable anxiety disorder. Scores range from 0 to 24, with higher scores indicting increased anxiety symptoms. | Months 3 and 6 |
| Beck Depression Inventory (BDI) change | proportion achieving 50% symptom reduction or remission by 6 months | Month 6 |
| anxiety in epilepsy survey instrument (EASI) change | proportion achieving 50% symptom reduction or remission by 6 months | Month 6 |
| Sustainability - insurance payment (quantity) for collaborative care billing codes | only measured in Aim 3 - sustainability supplement - intervention only clinical care delivery with insurance billing | Month 6 |
| Sustainability - did insurance pay (yes/no) for collaborative care billing | only measured in Aim 3 - sustainability supplement - intervention only clinical care delivery with insurance billing | Month 6 |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |