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NCT Number: NCT07509190

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Anny Reyes, PhD

CONTACT

[email protected]

216-390-4266

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEERS Program

Behavioral

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

Surveys

Other

Participants will receive surveys to assess barriers to accessing epilepsy care

Focus Group

Other

Participants will participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

Primary outcomes

  1. Part 2a: Identify primary barriers to accessing and undergoing epilepsy surgery

    Time frame: At study enrollment

    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)

  2. Part 2b: Further identify barriers associated with lack of access and utilization of epilepsy surgery

    Time frame: At study enrollment

    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

  3. Part 3: Determine acceptability of PEERS Program

    Time frame: Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit

    Acceptability will be measured by baseline and post-intervention assessment completion, with success defined as greater than 80% of participants completing both assessments.

  4. Part 3: Determine satisfaction of PEERS Program

    Time frame: Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit

    Measured by the Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction)

  5. Part 3: Determine effectiveness of PEERS Program

    Time frame: Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit

    Measured by the Trust in Physician Scale (Min-Max 11-55; higher number is higher level of trust)

Secondary outcomes

  1. Part 2b: Reporting of social needs

    Time frame: At study enrollment

    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

  2. Part 3: Reporting of social needs

    Time frame: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit

    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

  3. Part 2b: To assess knowledge of epilepsy surgery

    Time frame: At study enrollment

    Measured by responses to the Epilepsy Surgery Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)

  4. Part 3: To assess knowledge of epilepsy surgery

    Time frame: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit

    Measured by responses to the Epilepsy Surgery Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)

  5. Part 2b: To assess knowledge of social determinants of health

    Time frame: At study enrollment

    Measured by responses to the Social Determinants of Health Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)

  6. Part 3: To assess knowledge of social determinants of health

    Time frame: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit

    Measured by responses to the Social Determinants of Health Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)

  7. Part 2b: Determine participants' positivity towards living with a chronic condition

    Time frame: At study enrollment

    Measured by the Living with Chronic Illness Scale (min/max 0-104; higher values reflects more positive attitude towards living with a chronic condition)

  8. Part 3: Determine participants' positivity towards living with a chronic condition

    Time frame: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit

    Measured by the Living with Chronic Illness Scale (min/max 0-104; higher values reflects more positive attitude towards living with a chronic condition)

Study contacts

Contact information is provided by the study sponsor or research team.

Anny Reyes, PhD

CONTACT

[email protected]

216-390-4266

Sponsors and collaborators

Lead sponsor

Anny Reyes

Other

Collaborators

  • American Epilepsy Society

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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