Goals for Epilepsy Clinic Visits Trial
- Conditions
- Drug Resistant Epilepsy
- Interventions
- Behavioral: Questionnaires for ProvidersBehavioral: Survey questionnairesBehavioral: Epilepsy Visit Planner
- Registration Number
- NCT05928598
- Lead Sponsor
- University of Michigan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention arm (Epilepsy Visit Planner) - provider participants Questionnaires for Providers Epilepsy providers will be recruited from the University of Michigan (approximately 10 providers). Intervention arm (Epilepsy Visit Planner) - patient participants Survey questionnaires This group will be enrolled after the standard care arm enrollment is completed. Standard care arm - patient participants Survey questionnaires This group will be enrolled first. Intervention arm (Epilepsy Visit Planner) - patient participants Epilepsy Visit Planner This group will be enrolled after the standard care arm enrollment is completed.
- Primary Outcome Measures
Name Time Method Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), difference in mean score between trial arms Baseline 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).
- Secondary Outcome Measures
Name Time Method Acceptability of Intervention Measure, assessed in intervention arm Baseline - intervention arm only 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.
Quality of Life in Epilepsy (QOLIE-10) inventory, difference in mean score between trial arms 3 months after baseline visit 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).
Perceived Involvement in Care (PICS), difference in mean score between trial arms Baseline 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.
Feasibility, assessed in intervention arm Baseline - intervention arm only 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.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States