Recruiting

Epilepsy Visit Planner

Sponsor:

University of Michigan

Code:

NCT05928598

Conditions

Drug Resistant Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survey questionnaires

Epilepsy Visit Planner

Questionnaires for Providers

Study Details

Brief summary:

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:

  • 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.

Conditions

Drug Resistant Epilepsy

Study ID

NCT05928598

Start date

Sep 27, 2023

Status verified date

Oct, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria - Patient Participants:

  • Adults with drug-resistant epilepsy
  • Participants receiving care through the Epilepsy clinics at the University of Michigan

Exclusion Criteria - Patient Participants:

  • <18 years old
  • Non-English speaking
  • Do not clearly have drug-resistant epilepsy
  • Moderate-to-severe cognitive impairment that precludes study questionnaire completion

Inclusion Criteria - Provider Participants:

-University of Michigan epilepsy providers

Exclusion Criteria - Provider Participants:

-Not University of Michigan epilepsy providers

Study Design

Enrollment

152 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Standard care arm - patient participants

This group will be enrolled first.

experimental: Intervention arm (Epilepsy Visit Planner) - patient participants

This group will be enrolled after the standard care arm enrollment is completed.

other: Intervention arm (Epilepsy Visit Planner) - provider participants

Epilepsy providers will be recruited from the University of Michigan (approximately 10 providers).

Interventions

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.

Primary outcome measure

  • Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), difference in mean score between trial arms [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Queen Bolden

734-615-5495qmbolden@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Queen Bolden

qmbolden@umich.edu

Principal Investigator:

Chloe Hill, MD

More Information

Sponsor

University of Michigan

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • Survey
  • Quality of life
  • Communication tool
  • Patient-provider communication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-10-20.