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| ID | Type | Description | Link |
|---|---|---|---|
| K23NS126495-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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:
Additionally, there is a related survey project that is not part of the clinical trial and will not be included in this registration information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care arm - patient participants | Other | This group will be enrolled first. |
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| Intervention arm (Epilepsy Visit Planner) - patient participants | Experimental | This group will be enrolled after the standard care arm enrollment is completed. |
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| Intervention arm (Epilepsy Visit Planner) - provider participants | Other | Epilepsy providers will be recruited from the University of Michigan (approximately 10 providers). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria - Patient Participants:
Exclusion Criteria - Patient Participants:
Inclusion Criteria - Provider Participants:
-University of Michigan epilepsy providers
Exclusion Criteria - Provider Participants:
-Not University of Michigan epilepsy providers
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Queen Bolden | Contact | 734-615-5495 | qmbolden@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chloe Hill, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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 for an approximate total of 152 participants. Additionally, approximately 10 providers will be enrolled.
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| 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. |
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| Questionnaires for Providers | Behavioral | Providers will be asked to complete a survey after the clinic visit for the intervention group. |
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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 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |