Cleveland Clinic
Cleveland, Ohio, 44195, United States
Location status: Recruiting
NCT Number: NCT07509190
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Participants will receive surveys to assess barriers to accessing epilepsy care
Participants will participate in focus groups to further identify barriers associated with lack of access and utilization of 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)
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
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.
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)
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)
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
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
Time frame: At study enrollment
Measured by responses to the Epilepsy Surgery Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)
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)
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)
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)
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)
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)
Contact information is provided by the study sponsor or research team.
Anny Reyes
Other
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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