Bridging the Gap: Educating Patients on Social Determinants of Health to Improve Epilepsy Surgery Access and Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Other: Surveys; Other: Focus group; Behavioral: PEERS Program

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anny Reyes, PhD; Phone Number: 216-390-4266; Email: REYESA14@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Anny Reyes, PhD; Phone Number: 216-390-4266; Email: REYESA14@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Part 1:
• Epilepsy diagnosis
• Completion of epilepsy surgical evaluation at Cleveland Clinic
• Recommendation for resective/ablation surgery or implantation of neurostimulation device
• At least 18 years old
• Part 2a - Patient survey:
• At least 18 years old
• Epilepsy diagnosis
• Evaluated for epilepsy surgery
• English proficiency enough to complete survey
• Part 2a - Provider survey:
• Healthcare professional in the US who is involved in the clinical care or treatment of individuals with epilepsy
• Part 2b - Cleveland Clinic patient focus groups:
• Epilepsy diagnosis
• Previously completed epilepsy workup at Cleveland Clinic
• At least 18 years old
• Has Basic Interpersonal Fluency Skills in English (based on phone interview)
• Has no evidence of dementia or intellectual disability that would interfere with participation in the focus group
• Part 2b - Cleveland Clinic provider focus groups:
• Clinicians that are members of Cleveland Clinic Epilepsy Center and provide care to patients with epilepsy
• Part 2b - Community patient focus groups:
• Epilepsy diagnosis
• Previously completed epilepsy workup
• At least 18 years old
• Has Basic Interpersonal Fluency Skills in English (based on phone interview)
• Part 2b - Community provider focus groups:
• Clinician that provides care to patients with epilepsy outside of Cleveland Clinic
• Part 3:
• At least 18 years old
• Fluent in English
• Being evaluated for epilepsy surgery at the Cleveland Clinic Epilepsy Monitoring Unit

Exclusion Criteria:

• Part 1:
• Previous epilepsy surgery or implantation of neurostimulation device
• Part 2a - Patient survey:
• Unable to fluently read English
• Has evidence of dementia or intellectual disability that would interfere with patient's understanding of surveys
• Part 2a - Provider survey:
• Unable to fluently read English
• Part 2b - Cleveland Clinic patient focus groups:
• Is not fluent in English
• Has evidence of dementia or intellectual disability that would interfere with patient's understanding of or ability to participate in the focus group
• Has had prior epilepsy surgery
• Part 2b - Cleveland Clinic provider focus groups:
• Clinicians involved in the development of the study design
• Part 2b - Community patient focus groups:
• Is not fluent in English
• Has evidence of dementia or intellectual disability that would interfere with patient's understanding of or ability to participate in the focus group
• Has had prior epilepsy surgery
• Part 3:
• Is not fluent in English
• Evidence of dementia or intellectual disability that would interfere with patient's understanding of intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Part 2a: Patient Survey; Patients will receive online surveys to collect data to assess barriers to accessing epilepsy surgery	Other: Surveys; Participants will receive surveys to assess barriers to accessing epilepsy care
Other: Part 2a: Provider Survey; Epilepsy providers will receive online surveys to collect data to assess barriers patients experience in accessing epilepsy surgery	Other: Surveys; Participants will receive surveys to assess barriers to accessing epilepsy care
Other: Part 2b: Cleveland Clinic Patient Focus Group; 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	Other: Focus group; Participants will participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery
Other: Part 2b: Cleveland Clinic Provider Focus Group; 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	Other: Focus group; Participants will participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery
Other: Part 2b: Community Patient Focus Group; 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	Other: Focus group; Participants will participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery
Other: Part 2b: Community Provider Focus Group; 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	Other: Focus group; Participants will participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery
Experimental: Part 3: 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.	Behavioral: PEERS Program; This is a video-based intervention complemented by additional education materials, focusing on educating people with epilepsy on the impact of social determinants of health on epilepsy surgery and outcomes; Other Names: Patient Empowerment through Education on Equity Research and Social Determinants Program
No Intervention: Part 3: Control; Patients will have care as usual while they are in the Cleveland Clinic Epilepsy Monitoring Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 2a: Identify primary barriers to accessing and undergoing epilepsy surgery	People with epilepsy and providers will be asked to complete a roughly 20 minutes online survey (providers receive a different form of the survey than what patients receive)	At study enrollment
Part 2b: Further identify barriers associated with lack of access and utilization of epilepsy surgery	People with epilepsy and epilepsy providers (both from within Cleveland Clinic and from the outside community) will be asked to fill out surveys and participate in focus groups with semi-structured interviews	At study enrollment
Part 3: Determine acceptability of PEERS Program	Acceptability will be measured by baseline and post-intervention assessment completion, with success defined as greater than 80% of participants completing both assessments.	Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 3: Determine satisfaction of PEERS Program	Measured by the Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction)	Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 3: Determine effectiveness of PEERS Program	Measured by the Trust in Physician Scale (Min-Max 11-55; higher number is higher level of trust)	Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 2b: Reporting of social needs	The Accountable Health Communities Health-Related Social Needs Screening Tool will be used to assess participants' reporting of social needs. This is a screening tool so there are no high/low values or total score	At study enrollment
Part 3: Reporting of social needs	The Accountable Health Communities Health-Related Social Needs (HRSN) Screening Tool will be used to assess participants' reporting of social needs. This is a screening tool so there are not high/low values or total scores	At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 2b: To assess knowledge of epilepsy surgery	Measured by responses to the Epilepsy Surgery Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)	At study enrollment
Part 3: To assess knowledge of epilepsy surgery	Measured by responses to the Epilepsy Surgery Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)	At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 2b: To assess knowledge of social determinants of health	Measured by responses to the Social Determinants of Health Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)	At study enrollment
Part 3: To assess knowledge of social determinants of health	Measured by responses to the Social Determinants of Health Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)	At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 2b: Determine participants' positivity towards living with a chronic condition	Measured by the Living with Chronic Illness Scale (min/max 0-104; higher values reflects more positive attitude towards living with a chronic condition)	At study enrollment
Part 3: Determine participants' positivity towards living with a chronic condition	Measured by the Living with Chronic Illness Scale (min/max 0-104; higher values reflects more positive attitude towards living with a chronic condition)	At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit

Collaborators and Investigators

• Sponsor: Anny Reyes
• Collaborators: American Epilepsy Society
• Investigators: Principal Investigator: Anny Reyes, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires; Focus Groups
• Other Study ID Numbers: IRB 25-693; AES2510AR (Other Grant/Funding Number: American Epilepsy Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No