Goals for Epilepsy Clinic Visits Trial

NCT05928598 | Recruiting

• 2 other identifiers: HUM00231921K23NS126495-02
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Perceived Involvement in Care (PICS), difference in mean score between trial arms

  Baseline

• Quality of Life in Epilepsy (QOLIE-10) inventory, difference in mean score between trial arms

  3 months after baseline visit

• Feasibility, assessed in intervention arm

  Baseline - intervention arm only

• Acceptability of Intervention Measure, assessed in intervention arm

  Baseline - intervention arm only

Study Arms (3)

Standard care arm - patient participants

OTHER

This group will be enrolled first.

Behavioral: Survey questionnaires

Intervention arm (Epilepsy Visit Planner) - patient participants

EXPERIMENTAL

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

Behavioral: Survey questionnaires; Behavioral: Epilepsy Visit Planner

Intervention arm (Epilepsy Visit Planner) - provider participants

OTHER

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

Behavioral: Questionnaires for Providers

Interventions

Survey questionnaires BEHAVIORAL

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; Standard care arm - patient participants

Epilepsy Visit Planner BEHAVIORAL

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) - patient participants

Questionnaires for Providers BEHAVIORAL

Providers will be asked to complete a survey after the clinic visit for the intervention group.

Intervention arm (Epilepsy Visit Planner) - provider participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Chloe Hill, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Queen Bolden

CONTACT

734-615-5495; qmbolden@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: Enrollment for the trial will include 76 participants for the standard care arm and will include 76 participants for the intervention arm (who will receive the Epilepsy Visit Planner). The study team will enroll for the standard arm and then for the intervention arm for an approximate total of 152 participants. Additionally, approximately 10 providers will be enrolled.

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 3, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)