Goals for Epilepsy Clinic Visits Trial

Study Overview
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Brief Summary
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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.

Official Title
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Drug-Resistant Epilepsy (DRE) Goals for Epilepsy Clinical Visits mHealth Epilepsy Visit Planner Trial

Conditions
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Drug Resistant Epilepsy

Intervention / Treatment
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* Behavioral: Survey questionnaires
* Behavioral: Epilepsy Visit Planner
* Behavioral: Questionnaires for Providers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard care arm - patient participants<br>This group will be enrolled first. | Behavioral: Survey questionnaires<br>* 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.<br>|
| Experimental: Intervention arm (Epilepsy Visit Planner) - patient participants<br>This group will be enrolled after the standard care arm enrollment is completed. | Behavioral: Survey questionnaires<br>* 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.<br>Behavioral: Epilepsy Visit Planner<br>* 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.<br>|
| Other: Intervention arm (Epilepsy Visit Planner) - provider participants<br>Epilepsy providers will be recruited from the University of Michigan (approximately 10 providers). | Behavioral: Questionnaires for Providers<br>* Providers will be asked to complete a survey after the clinic visit for the intervention group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Involvement in Care (PICS), difference in mean score between trial arms | 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. | Baseline | 
| Quality of Life in Epilepsy (QOLIE-10) inventory, 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 (lower score indicates better health outcome). | 3 months after baseline visit | 
| Feasibility, assessed in intervention arm | 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. | Baseline - intervention arm only | 
| Acceptability of Intervention Measure, assessed in intervention arm | 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. | Baseline - intervention arm only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Survey, Quality of life, Communication tool, Patient-provider communication