An interventional study of Survey questionnaires and Epilepsy Visit Planner in Drug Resistant Epilepsy, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by University of Michigan · Not applicable, Interventional, and Health services research
The purpose of this project is to conduct a trial to assess whether patients that receive a tablet-based waiting room priority communication tool (the "Epilepsy Visit Planner") have improved outcomes compared to patients that do not receive the tool.
The project's hypotheses are:
Additionally, there is a related survey project that is not part of the clinical trial and will not be included in this registration information.
261 studies on the registry are indexed under Drug Resistant Epilepsy; 99 are open to participants now.
This study's planned enrollment of 152 is above the median of 30 across 208 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - Patient Participants:
Exclusion Criteria - Patient Participants:
Inclusion Criteria - Provider Participants:
-University of Michigan epilepsy providers
Exclusion Criteria - Provider Participants:
-Not University of Michigan epilepsy providers
This group will be enrolled first.
Behavioral: Survey questionnaires
This group will be enrolled after the standard care arm enrollment is completed.
Behavioral: Survey questionnaires · Behavioral: Epilepsy Visit Planner
Epilepsy providers will be recruited from the University of Michigan (approximately 10 providers).
Behavioral: Questionnaires for Providers
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.
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.
Providers will be asked to complete a survey after the clinic visit for the intervention group.
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), difference in mean score between trial arms
This is a 10-item measure with Likert scale (range 1-5 for each response) with a score range of 10-50 (higher score indicating higher perceived efficacy in communicating with providers).
Time frame: Baseline
Perceived Involvement in Care (PICS), difference in mean score between trial arms
This is a 13-item measure with binary agree/disagree responses (0 points for disagree and 1 point for agree) and higher scores reflecting a greater degree of perceived patient activity and involvement.
Time frame: Baseline
Quality of Life in Epilepsy (QOLIE-10) inventory, difference in mean score between trial arms
This is a 10-item measure with Likert scale (range 1-5 for each response) with a score range of 10-50 (lower score indicates better health outcome).
Time frame: 3 months after baseline visit
Feasibility, assessed in intervention arm
Three questions will be asked regarding if the Planner was completed, if the Planner was shared during the visit, and how the Planner impacted visit length. Both patient participants and provider participants will complete these questions.
Time frame: Baseline - intervention arm only
Acceptability of Intervention Measure, assessed in intervention arm
There are 4 questions that will be completed by the patient participants and provider participants that evaluate the acceptability of the intervention. The question responses have a Likert scale from 1(completely disagree) to 5 (completely agree). There is a range from 5-25 with a higher score indicating a higher acceptability of the intervention tool.
Time frame: Baseline - intervention arm only
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Michigan