Clinical trial NCT05928598: Goals for Epilepsy Clinic Visits Trial
Official title: Drug-Resistant Epilepsy (DRE) Goals for Epilepsy Clinical Visits MHealth Epilepsy Visit Planner Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Resistant Epilepsy
Keywords: Survey
Quality of life
Communication tool
Patient-provider communication
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-07-03
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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. Additionally, approximately 10 providers will be enrolled for an approximate total of 162 participants.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), difference in mean score between trial arms
timeFrame: Baseline
Secondary outcomes:
measure: Perceived Involvement in Care (PICS), difference in mean score between trial arms
timeFrame: Baseline
measure: Quality of Life in Epilepsy (QOLIE-10) inventory, difference in mean score between trial arms
timeFrame: 3 months after baseline visit
measure: Feasibility, assessed in intervention arm
timeFrame: Baseline - intervention arm only
measure: Acceptability of Intervention Measure, assessed in intervention arm
timeFrame: Baseline - intervention arm only
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Chloe Hill, MD
role: PRINCIPAL_INVESTIGATOR
References: