Bridging the Gap: Educating Patients on Social Determinants of Health to Improve Epilepsy Surgery Access and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Part 2a: Identify primary barriers to accessing and undergoing epilepsy surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •At least 18 years old
- •Fluent in English
- •Being evaluated for epilepsy surgery at the Cleveland Clinic Epilepsy Monitoring Unit
排除标准
- •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
- •Is not fluent in English
- •Evidence of dementia or intellectual disability that would interfere with patient's understanding of intervention
研究组 & 干预措施
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
干预措施: Focus group (Other)
Part 2a: Patient Survey
Patients will receive online surveys to collect data to assess barriers to accessing epilepsy surgery
干预措施: Surveys (Other)
Part 2a: Provider Survey
Epilepsy providers will receive online surveys to collect data to assess barriers patients experience in accessing epilepsy surgery
干预措施: Surveys (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
干预措施: Focus group (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
干预措施: Focus group (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
干预措施: Focus group (Other)
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.
干预措施: PEERS Program (Behavioral)
Part 3: Control
Patients will have care as usual while they are in the Cleveland Clinic Epilepsy Monitoring Unit
结局指标
主要结局
Part 2a: Identify primary barriers to accessing and undergoing epilepsy surgery
时间窗: 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)
Part 2b: Further identify barriers associated with lack of access and utilization of epilepsy surgery
时间窗: 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
Part 3: Determine acceptability of PEERS Program
时间窗: 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.
Part 3: Determine satisfaction of PEERS Program
时间窗: 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)
Part 3: Determine effectiveness of PEERS Program
时间窗: 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)
次要结局
- Part 2b: Reporting of social needs(At study enrollment)
- Part 3: Reporting of social needs(At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit)
- Part 2b: To assess knowledge of epilepsy surgery(At study enrollment)
- Part 3: To assess knowledge of epilepsy surgery(At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit)
- Part 2b: To assess knowledge of social determinants of health(At study enrollment)
- Part 3: To assess knowledge of social determinants of health(At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit)
- Part 2b: Determine participants' positivity towards living with a chronic condition(At study enrollment)
- Part 3: Determine participants' positivity towards living with a chronic condition(At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit)
研究者
Anny Reyes
Associate Staff
The Cleveland Clinic