Goals for Epilepsy Clinic Visits Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Survey questionnaires, Epilepsy Visit Planner, Questionnaires for Providers.
- Who it may be relevant to
- Registry conditions: Drug Resistant Epilepsy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Drug-Resistant Epilepsy (DRE) Goals for Epilepsy Clinical Visits mHealth Epilepsy Visit Planner Trial
Overview
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.
Interventions
- 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 presentati - Behavioral Questionnaires for Providers
Providers will be asked to complete a survey after the clinic visit for the intervention group.
Primary outcome measures
- Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), difference in mean score between trial arms [Time frame: Baseline]
Secondary outcome measures (4)
- Perceived Involvement in Care (PICS), difference in mean score between trial arms [Time frame: Baseline]
- Quality of Life in Epilepsy (QOLIE-10) inventory, difference in mean score between trial arms [Time frame: 3 months after baseline visit]
- Feasibility, assessed in intervention arm [Time frame: Baseline - intervention arm only]
- Acceptability of Intervention Measure, assessed in intervention arm [Time frame: Baseline - intervention arm only]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT05928598 · HUM00231921 · K23NS126495-02