Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
152 participants
INTERVENTIONAL
2023-09-27
2027-01-01
Brief Summary
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The project's hypotheses are:
* Patients that receive the Epilepsy Visit Planner will have improved patient-provider communication compared to the non-planner group.
* Patients that receive the Epilepsy Visit Planner will have improved quality of life scores.
* The Epilepsy Visit Planner will score highly on process measures of feasibility and acceptability, demonstrating suitability for future larger scale study.
Additionally, there is a related survey project that is not part of the clinical trial and will not be included in this registration information.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard care arm - patient participants
This group will be enrolled first.
Survey questionnaires
Participants will be enrolled before a scheduled clinic appointment. Following the clinic visit, the research staff will ask the patient to complete questionnaires electronically (or by phone if patient prefers) within three days after the baseline clinic visit and then at three months following this visit. Additionally, some data will be obtained from the participant's medical record.
Intervention arm (Epilepsy Visit Planner) - patient participants
This group will be enrolled after the standard care arm enrollment is completed.
Survey questionnaires
Participants will be enrolled before a scheduled clinic appointment. Following the clinic visit, the research staff will ask the patient to complete questionnaires electronically (or by phone if patient prefers) within three days after the baseline clinic visit and then at three months following this visit. Additionally, some data will be obtained from the participant's medical record.
Epilepsy Visit Planner
Participants will be identified before a scheduled clinic appointment. Prior to the clinic visit (at the site) the participants will meet with a research staff to obtain written informed consent and then present the Epilepsy Visit Planner to the patient. Participants will be encouraged to use the Planner and share the Planner's output with the provider during the clinic visit. In some cases, there could be an option for the participants to consent prior to the visit and have a virtual presentation of the Planner.
Following the clinic visit, the research staff will ask the participants to complete questionnaires electronically (or by phone if patient prefers) within three days after the baseline clinic visit and then at three months following this visit. Additionally, some data will be obtained from the participant's medical record.
Intervention arm (Epilepsy Visit Planner) - provider participants
Epilepsy providers will be recruited from the University of Michigan (approximately 10 providers).
Questionnaires for Providers
Providers will be asked to complete a survey after the clinic visit for the intervention group.
Interventions
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Survey questionnaires
Participants will be enrolled before a scheduled clinic appointment. Following the clinic visit, the research staff will ask the patient to complete questionnaires electronically (or by phone if patient prefers) within three days after the baseline clinic visit and then at three months following this visit. Additionally, some data will be obtained from the participant's medical record.
Epilepsy Visit Planner
Participants will be identified before a scheduled clinic appointment. Prior to the clinic visit (at the site) the participants will meet with a research staff to obtain written informed consent and then present the Epilepsy Visit Planner to the patient. Participants will be encouraged to use the Planner and share the Planner's output with the provider during the clinic visit. In some cases, there could be an option for the participants to consent prior to the visit and have a virtual presentation of the Planner.
Following the clinic visit, the research staff will ask the participants to complete questionnaires electronically (or by phone if patient prefers) within three days after the baseline clinic visit and then at three months following this visit. Additionally, some data will be obtained from the participant's medical record.
Questionnaires for Providers
Providers will be asked to complete a survey after the clinic visit for the intervention group.
Eligibility Criteria
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Inclusion Criteria
* Participants receiving care through the Epilepsy clinics at the University of Michigan
-University of Michigan epilepsy providers
Exclusion Criteria
* Non-English speaking
* Do not clearly have drug-resistant epilepsy
* Moderate-to-severe cognitive impairment that precludes study questionnaire completion
-Not University of Michigan epilepsy providers
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Michigan
OTHER
Responsible Party
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Chloe Hill
Assistant Professor of Neurology
Principal Investigators
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Chloe Hill, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00231921
Identifier Type: -
Identifier Source: org_study_id
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