Teaching adults with epilepsy how social factors affect surgery access and outcomes

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

This project will test whether giving adults with epilepsy extra education about social factors that affect care increases access to epilepsy surgery and improves outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 310 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT07509190 on ClinicalTrials.gov

What this trial studies

The project first uses surveys and focus groups with adults who have epilepsy and with clinicians to identify social and practical barriers to epilepsy surgery. It then pilots an educational program at the Cleveland Clinic Epilepsy Monitoring Unit where adult patients are randomized to receive usual care or usual care plus targeted materials about social determinants of health and their influence on surgical rates and outcomes. Participants complete questionnaires at the beginning and end of their stay to measure knowledge, attitudes, and decision-making related to surgery. Study findings will be used to refine the educational materials and strategies to improve equitable access to epilepsy surgery.

Who should consider this trial

Good fit: Adults (18+) with epilepsy who have completed or are undergoing surgical evaluation at Cleveland Clinic and English-literate patients admitted to the Epilepsy Monitoring Unit are ideal candidates.

Not a fit: Patients who are not pursuing surgery, who lack sufficient English to use the materials, or who are not treated at Cleveland Clinic are unlikely to benefit directly from this pilot.

Why it matters

Potential benefit: If successful, the program could help more eligible patients overcome social barriers and complete epilepsy surgery, potentially improving seizure outcomes.

How similar studies have performed: Educational interventions addressing social determinants have shown benefits in other medical areas, but applying this approach specifically to increase epilepsy surgery access is largely novel.

Eligibility criteria

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Anny Reyes, PhD — The Cleveland Clinic
• Study coordinator: Anny Reyes, PhD

Conditions Epilepsy