Goals for Epilepsy Clinic Visits Trial

University of Michigan

Status: Enrolling

Conditions: Drug Resistant Epilepsy

Treatments: Behavioral: Survey questionnaires; Behavioral: Questionnaires for Providers; Behavioral: Epilepsy Visit Planner

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05928598

K23NS126495-02 (U.S. NIH Grant/Contract)

HUM00231921

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

152 participants in 3 patient groups

Standard care arm - patient participants

Other group

Description:

This group will be enrolled first.

Treatment:

Behavioral: Survey questionnaires

Intervention arm (Epilepsy Visit Planner) - patient participants

Experimental group

Description:

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

Treatment:

Behavioral: Epilepsy Visit Planner

Behavioral: Survey questionnaires

Intervention arm (Epilepsy Visit Planner) - provider participants

Other group

Description:

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

Treatment:

Behavioral: Questionnaires for Providers