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Goals for Epilepsy Clinic Visits Trial

ConditionDrug Resistant Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adults with drug-resistant epilepsy

Participants receiving care through the Epilepsy clinics at the University of Michigan

Disqualifiers

<18 years old

Non-English speaking

Do not clearly have drug-resistant epilepsy

Moderate-to-severe cognitive impairment that precludes study questionnaire completion

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

152 Participants
are divided into 3 treatment groups
Group A: Standard care arm - patient participantsOther 1 intervention
Group B: Intervention arm (Epilepsy Visit Planner) - patient participantsExperimental treatment 2 interventions
Group C: Intervention arm (Epilepsy Visit Planner) - provider participantsOther 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline
2

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).

Time frame
3 months after baseline visit
3

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.

Time frame
Baseline - intervention arm only
4

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.

Time frame
Baseline - intervention arm only

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
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