Goals for Epilepsy Clinic Visits Trial

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05928598
Status
Recruiting
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Conditions

  • Drug Resistant Epilepsy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Sep 27, 2023
Status verified
Oct 2025
Primary completion
Sep 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
152 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Queen Bolden
[email protected]
Chloe Hill, MD (PRINCIPAL_INVESTIGATOR)

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University of Michigan· Ann Arbor, MI

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