PEERS Program for Epilepsy

Overseen By Anny Reyes, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Anny Reyes

Disqualifiers: Prior epilepsy surgery, Dementia, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to identify the needs and barriers to accessing and undergoing epilepsy surgery for patients with epilepsy and then to pilot an educational program regarding the social determinants of health and how they can influence surgical rates and epilepsy outcomes.

For the first part, patients (age 18+) and providers will be asked to complete surveys and participate in focus groups to identify gaps and barriers that limit access to and use of epilepsy surgery.

For piloting the education program, patients (age 18+) at the Cleveland Clinic Epilepsy Monitoring Unit will be randomized to intervention or control. Those in the intervention group, in addition to their usual care, will also receive educational materials on social determinants of health and their influence on surgical rates and epilepsy outcomes. Those in the control group will receive their usual care. Both groups will be asked to fill out surveys and questionnaires at the beginning of their stay, at the end of their stay, and if they elect to have surgery, 12 months after surgery.

Who Is on the Research Team?

Anny Reyes, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with epilepsy.

I do not have dementia or intellectual disabilities that affect my participation.

Previously completed epilepsy workup

Exclusion Criteria

I do not have dementia or intellectual disabilities that affect my understanding.

I do not have dementia or intellectual disabilities that affect my understanding.

I have had epilepsy surgery or a neurostimulation device implanted.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Survey and Focus Groups

Patients and providers complete surveys and participate in focus groups to identify barriers to epilepsy surgery

At study enrollment

1 visit (in-person or virtual)

Intervention

Patients in the intervention group receive educational materials on social determinants of health while in the Cleveland Clinic Epilepsy Monitoring Unit

During hospital stay

In-patient stay

Follow-up

Participants are monitored for satisfaction and effectiveness of the educational program

12 months after surgery if elected

Surveys at baseline, prior to discharge, and 12 months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• PEERS Program

How Is the Trial Designed?

Group I: Part 3: Intervention Experimental Treatment 1 Intervention

Patients will view an educational video on social determinants of health and how these social determinants impact medical care while they are in the Cleveland Clinic Epilepsy Monitoring Unit in addition to their normal care.

Group II: Part 2b: Community Provider Focus Group Experimental Treatment 1 Intervention

Non-Cleveland Clinic epilepsy providers will fill out questionnaires and participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

Group III: Part 2b: Community Patient Focus Group Experimental Treatment 1 Intervention

Non-Cleveland Clinic patients with epilepsy will fill out questionnaires and participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

Group IV: Part 2b: Cleveland Clinic Provider Focus Group Experimental Treatment 1 Intervention

Cleveland Clinic epilepsy providers will fill out questionnaires and participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

Group V: Part 2b: Cleveland Clinic Patient Focus Group Experimental Treatment 1 Intervention

Cleveland Clinic patients with epilepsy will fill out questionnaires and participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

Group VI: Part 2a: Provider Survey Experimental Treatment 1 Intervention

Epilepsy providers will receive online surveys to collect data to assess barriers patients experience in accessing epilepsy surgery

Group VII: Part 2a: Patient Survey Experimental Treatment 1 Intervention

Patients will receive online surveys to collect data to assess barriers to accessing epilepsy surgery

Group VIII: Part 3: Control Active Control 1 Intervention

Patients will have care as usual while they are in the Cleveland Clinic Epilepsy Monitoring Unit

Who Is Running the Clinical Trial?

Anny Reyes

Lead Sponsor

American Epilepsy Society

Collaborator

Trials

8

Recruited

250+