[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632092":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":50,"studyPopulation":50,"armGroups":57,"interventions":94,"overallOfficials":110,"centralContacts":114,"locations":119,"responsibleParty":136,"collaborators":140,"id":143,"slug":50,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":50,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":149,"minAge":150,"maxAge":50,"enrollmentInfo":151,"targetDuration":50,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":50,"overallStatus":122,"whyStopped":50,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":50},[9,13,16,20,24],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":12},"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",{"measure":17,"description":18,"timeFrame":19},"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",{"measure":21,"description":22,"timeFrame":23},"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",{"measure":25,"description":26,"timeFrame":19},"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)",[28,31,35,38,40,43,45,48],{"measure":29,"description":30,"timeFrame":12},"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\u002Flow values or total score",{"measure":32,"description":33,"timeFrame":34},"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\u002Flow values or total scores","At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit",{"measure":36,"description":37,"timeFrame":12},"Part 2b: To assess knowledge of epilepsy surgery","Measured by responses to the Epilepsy Surgery Knowledge Questionnaire (min\u002Fmax 0-10; higher scores indicate higher knowledge)",{"measure":39,"description":37,"timeFrame":34},"Part 3: To assess knowledge of epilepsy surgery",{"measure":41,"description":42,"timeFrame":12},"Part 2b: To assess knowledge of social determinants of health","Measured by responses to the Social Determinants of Health Knowledge Questionnaire (min\u002Fmax 0-10; higher scores indicate higher knowledge)",{"measure":44,"description":42,"timeFrame":34},"Part 3: To assess knowledge of social determinants of health",{"measure":46,"description":47,"timeFrame":12},"Part 2b: Determine participants' positivity towards living with a chronic condition","Measured by the Living with Chronic Illness Scale (min\u002Fmax 0-104; higher values reflects more positive attitude towards living with a chronic condition)",{"measure":49,"description":47,"timeFrame":34},"Part 3: Determine participants' positivity towards living with a chronic condition",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"RANDOMIZED","SEQUENTIAL","SUPPORTIVE_CARE",{"masking":56,"maskingDescription":50,"whoMasked":50},"NONE",[58,63,67,72,76,80,84,90],{"label":59,"type":6,"description":60,"interventionNames":61},"Part 2a: Patient Survey","Patients will receive online surveys to collect data to assess barriers to accessing epilepsy surgery",[62],"Other: Surveys",{"label":64,"type":6,"description":65,"interventionNames":66},"Part 2a: Provider Survey","Epilepsy providers will receive online surveys to collect data to assess barriers patients experience in accessing epilepsy surgery",[62],{"label":68,"type":6,"description":69,"interventionNames":70},"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",[71],"Other: Focus group",{"label":73,"type":6,"description":74,"interventionNames":75},"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",[71],{"label":77,"type":6,"description":78,"interventionNames":79},"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",[71],{"label":81,"type":6,"description":82,"interventionNames":83},"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",[71],{"label":85,"type":86,"description":87,"interventionNames":88},"Part 3: Intervention","EXPERIMENTAL","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.",[89],"Behavioral: PEERS Program",{"label":91,"type":92,"description":93,"interventionNames":50},"Part 3: Control","NO_INTERVENTION","Patients will have care as usual while they are in the Cleveland Clinic Epilepsy Monitoring Unit",[95,102,106],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":100},"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",[85],[101],"Patient Empowerment through Education on Equity Research and Social Determinants Program",{"type":6,"name":103,"description":104,"armGroupLabels":105,"otherNames":50},"Surveys","Participants will receive surveys to assess barriers to accessing epilepsy care",[59,64],{"type":6,"name":107,"description":108,"armGroupLabels":109,"otherNames":50},"Focus group","Participants will participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery",[68,73,77,81],[111],{"name":112,"affiliation":5,"role":113},"Anny Reyes, PhD","PRINCIPAL_INVESTIGATOR",[115],{"name":112,"role":116,"phone":117,"phoneExt":50,"email":118},"CONTACT","216-390-4266","REYESA14@ccf.org",[120],{"facility":121,"status":122,"city":123,"state":124,"zip":125,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":133,"contacts":134},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":129,"coordinates":130},"Point",[131,132],-81.69541,41.4995,{"lat":132,"lon":131},[135],{"name":112,"role":116,"phone":117,"phoneExt":50,"email":118},{"type":137,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"SPONSOR_INVESTIGATOR","Anny Reyes","Associate Staff",[141],{"name":142,"class":6},"American Epilepsy Society","100632092",false,"NCT07509190","Bridging the Gap: Educating Patients on Social Determinants of Health to Improve Epilepsy Surgery Access and Outcomes","Inclusion Criteria:\n\n* Part 1:\n* Epilepsy diagnosis\n* Completion of epilepsy surgical evaluation at Cleveland Clinic\n* Recommendation for resective\u002Fablation surgery or implantation of neurostimulation device\n* At least 18 years old\n* Part 2a - Patient survey:\n* At least 18 years old\n* Epilepsy diagnosis\n* Evaluated for epilepsy surgery\n* English proficiency enough to complete survey\n* Part 2a - Provider survey:\n* Healthcare professional in the US who is involved in the clinical care or treatment of individuals with epilepsy\n* Part 2b - Cleveland Clinic patient focus groups:\n* Epilepsy diagnosis\n* Previously completed epilepsy workup at Cleveland Clinic\n* At least 18 years old\n* Has Basic Interpersonal Fluency Skills in English (based on phone interview)\n* Has no evidence of dementia or intellectual disability that would interfere with participation in the focus group\n* Part 2b - Cleveland Clinic provider focus groups:\n* Clinicians that are members of Cleveland Clinic Epilepsy Center and provide care to patients with epilepsy\n* Part 2b - Community patient focus groups:\n* Epilepsy diagnosis\n* Previously completed epilepsy workup\n* At least 18 years old\n* Has Basic Interpersonal Fluency Skills in English (based on phone interview)\n* Part 2b - Community provider focus groups:\n* Clinician that provides care to patients with epilepsy outside of Cleveland Clinic\n* Part 3:\n* At least 18 years old\n* Fluent in English\n* Being evaluated for epilepsy surgery at the Cleveland Clinic Epilepsy Monitoring Unit\n\nExclusion Criteria:\n\n* Part 1:\n* Previous epilepsy surgery or implantation of neurostimulation device\n* Part 2a - Patient survey:\n* Unable to fluently read English\n* Has evidence of dementia or intellectual disability that would interfere with patient's understanding of surveys\n* Part 2a - Provider survey:\n* Unable to fluently read English\n* Part 2b - Cleveland Clinic patient focus groups:\n* Is not fluent in English\n* Has evidence of dementia or intellectual disability that would interfere with patient's understanding of or ability to participate in the focus group\n* Has had prior epilepsy surgery\n* Part 2b - Cleveland Clinic provider focus groups:\n* Clinicians involved in the development of the study design\n* Part 2b - Community patient focus groups:\n* Is not fluent in English\n* Has evidence of dementia or intellectual disability that would interfere with patient's understanding of or ability to participate in the focus group\n* Has had prior epilepsy surgery\n* Part 3:\n* Is not fluent in English\n* Evidence of dementia or intellectual disability that would interfere with patient's understanding of intervention",true,"ALL","18 Years",{"count":152,"type":153},310,"ESTIMATED","INTERVENTIONAL",[156],"NA","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.\n\nFor 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.\n\nFor 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.",[159],"Epilepsy","2026-03-27",{"date":162,"type":163},"2026-04-03","ACTUAL",{"date":165,"type":163},"2026-03-18",{"date":167,"type":153},"2029-12",{"name":138,"class":6},1]