Goals for Epilepsy Clinic Visits Trial

Drug-Resistant Epilepsy (DRE) Goals for Epilepsy Clinical Visits mHealth Epilepsy Visit Planner Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Drug Resistant Epilepsy
• Intervention / Treatment: Behavioral: Survey questionnaires; Behavioral: Epilepsy Visit Planner; Behavioral: Questionnaires for Providers

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Queen Bolden; Phone Number: 734-615-5495; Email: qmbolden@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Queen Bolden; Email: qmbolden@umich.edu
      • Principal Investigator: Chloe Hill, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard care arm - patient participants; This group will be enrolled first.	Behavioral: 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.
Experimental: Intervention arm (Epilepsy Visit Planner) - patient participants; This group will be enrolled after the standard care arm enrollment is completed.	Behavioral: 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.; Behavioral: 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.
Other: Intervention arm (Epilepsy Visit Planner) - provider participants; Epilepsy providers will be recruited from the University of Michigan (approximately 10 providers).	Behavioral: Questionnaires for Providers; Providers will be asked to complete a survey after the clinic visit for the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	Baseline - intervention arm only

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Chloe Hill, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Survey; Patient-provider communication; Communication tool
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: HUM00231921; K23NS126495-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No