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

Обзор

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.

Вмешательства

• Поведенческое 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
• Другое Surveys
  Participants will receive surveys to assess barriers to accessing epilepsy care
• Другое Focus group
  Participants will participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

Первичные конечные точки

• Part 2a: Identify primary barriers to accessing and undergoing epilepsy surgery [Срок оценки: At study enrollment]
• Part 2b: Further identify barriers associated with lack of access and utilization of epilepsy surgery [Срок оценки: At study enrollment]
• Part 3: Determine acceptability of PEERS Program [Срок оценки: Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit]
• Part 3: Determine satisfaction of PEERS Program [Срок оценки: Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit]
• Part 3: Determine effectiveness of PEERS Program [Срок оценки: Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit]

Вторичные конечные точки (8)

• Part 2b: Reporting of social needs [Срок оценки: At study enrollment]
• Part 3: Reporting of social needs [Срок оценки: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit]
• Part 2b: To assess knowledge of epilepsy surgery [Срок оценки: At study enrollment]
• Part 3: To assess knowledge of epilepsy surgery [Срок оценки: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit]
• Part 2b: To assess knowledge of social determinants of health [Срок оценки: At study enrollment]
• Part 3: To assess knowledge of social determinants of health [Срок оценки: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit]
• Part 2b: Determine participants' positivity towards living with a chronic condition [Срок оценки: At study enrollment]
• Part 3: Determine participants' positivity towards living with a chronic condition [Срок оценки: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Cleveland Clinic — Cleveland

Идентификаторы

NCT: NCT07509190 · IRB 25-693 · AES2510AR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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