Clinic to Community© Program for Adults With Epilepsy Admitted to Emergency Departments

Study Overview
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Brief Summary
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Analysis of emergency department (ED) visits with a billing code for 'epilepsy' or 'seizure' found up to 37% are eligible for deferral. This study is a randomized controlled trial (RCT) of the Clinic To Community© program (C2C) as an intervention for adults with epilepsy visiting emergency departments at a mid size hospital in Ontario, Canada. Participants in the intervention arm receive patient education to improve knowledge of epilepsy and access to community-based services. Participants in the control group are wait-listed and receive patient education 12 months later. The study objective is to successfully implement, recruit and retain participants for this intervention and evaluate whether C2C will reduce the frequency of ED visits, reduce felt stigma and improve quality of life, epilepsy knowledge, and self-management skills.

Detailed Description
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Emergency care for epilepsy can be appropriate and even life-saving, but up to 37% of emergency department (ED) visits by persons with epilepsy (PWE) are potentially deferrable, resulting from persons with known epilepsy and uncomplicated seizures. Past studies have shown that low self-management confidence among PWE leads to frequent emergency visits to the hospital. Other factors associated with increased use of EDs are increased seizure frequency, reduced medication, sub-optimal self-management, increased anxiety, increased depression, increased felt-stigma, and lower social and medical epilepsy knowledge. In one catchment area in Ontario, Canada, the Southwest Local Health Integration Network (LHIN), there are an estimated 7508 prevalent cases of epilepsy associated with the use of approximately $55 million/year of provincial healthcare services. In addition, there are an estimated 433 incident cases costing an additional $4.6 million/year. Hospital care (including ED visits) accounts for 35.5% of the total cost equating to $21 million/year. Eliminating the 37% of deferrable ED visits equates to saving almost $8 million/year. The Clinic to Community© (C2C) epilepsy education program has been developed using best practices for patient education. The content has been divided into an introductory 60 minute face-to-face session supported by strategy sheets that can be accessed online at www.clinictocommunity.ca The Clinic To Community© program recognizes that epilepsy is unique among chronic conditions in that PWE lose their ability to make choices during a seizure and depend on the decisions of others including family, friends and colleagues to keep them safe. Many patients seek care in the ED to reduce their anxiety and for reassurance and that upon discharge from the ED, the inability to receive a prompt specialist appointment leads to the continued use of ED for these same patients. This is a parallel, pilot randomized controlled trial (RCT) comparing the Clinic To Community© program plus treatment-as-usual (TAU) with TAU only (i.e. wait-list control). This study will not interfere with patients' clinical care. Eligible patients visiting a participating ED will be given information about the study and if they agree, will be referred. The C2C program will be delivered in-person, one-on-one for 60 minutes by appointment on a rolling basis to minimize wait-times and allow timely access to the intervention. All participants will complete questionnaires before randomization and 12 months after randomization.

Official Title
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Clinic to Community© Program for Adults With Epilepsy Admitted to Emergency Departments: A Randomized Controlled Trial

Conditions
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Epilepsy, Generalized

Intervention / Treatment
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* Behavioral: Clinic to Community Education Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (aged ≥18 years) visiting a participating ED for a seizure or an epilepsy-related concern. Adults on anti-seizure medication prior to coming to the ED or prescribed anti-seizure medication at the ED. Providing informed consent and having sufficient English language skills to complete questionnaires and participate in the intervention. Exclusion Criteria: Previous participation in the C2C program. Known diagnosis of psychogenic non-epileptic seizures (PNES).

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a parallel, pilot randomized controlled trial (RCT) comparing the Clinic To Community© program plus treatment-as-usual (TAU) with TAU only (i.e. wait-list control).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Intervention Group. Participants randomized to the intervention group will complete the C2C program. They will receive an in-person one-on-one 60-minute education session and will be introduced to, and encouraged to participate in, the programs and support services that are provided by Epilepsy Southwestern Ontario (ESWO). As part of the C2C program, participants will be contacted 6 months later for a supplementary consultation over the telephone and to answer any questions. Epilepsy is unique among chronic, episodic disorders in that PWE lose their ability to make choices during a seizure and depend to a greater degree on the decisions of others including family, friends and colleagues. For this reason, we encourage the PWE to invite their support network to attend the patient education sessions. | Behavioral: Clinic to Community Education Program<br>* The C2C program aims to improve participants' knowledge of epilepsy and access to services and to provide support. Participants randomized to the intervention group will complete the C2C program. They will receive an in-person one-on-one 60-minute education session and will be introduced to, and encouraged to participate in, the programs and support services that are provided by Epilepsy Southwestern Ontario (ESWO).<br>|
| Other: Waitlist Control Group<br>Waitlist Control Group. The control group continues TAU and will be followed up 12 months after randomization. The control group will receive C2C after the 12-month follow-up. | Behavioral: Clinic to Community Education Program<br>* The C2C program aims to improve participants' knowledge of epilepsy and access to services and to provide support. Participants randomized to the intervention group will complete the C2C program. They will receive an in-person one-on-one 60-minute education session and will be introduced to, and encouraged to participate in, the programs and support services that are provided by Epilepsy Southwestern Ontario (ESWO).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of engagement with the Clinic To Community© (C2C) program | Evaluated by rate of ED referrals, rate of recruitment, rate of retention, and proportion who receive support education. | Throughout study completion, approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of epilepsy-related emergency department (ED) visits over the next 12 months | Change from baseline in frequency of ED visits and health care utilization, adapted from the Canadian Community Health Survey | Baseline (0), and 12 months | 
| Effect of participation in C2C on felt stigma using Stigma Scale of Epilepsy | Change from baseline in using the Stigma Scale of Epilepsy, 3-item scale asking: Because of epilepsy, (1) other people are uncomfortable with me; (2) treat me as inferior; (3) prefer to avoid me. Each of those questions is scored on a four-point scale: 0 not at all; 1 yes, maybe; 2 yes, probably; 3 yes, definitely. Total scores range from 0 to 9 and categorized as not stigmatized (score of 0), mild-moderate (1-6) and highly stigmatized (7-9). | Baseline (0) and 12 months | 
| Effect of participation in C2C on felt stigma using Epilepsy Stigma Scale | Change from baseline measured by Epilepsy Stigma Scale, a 10-item measure evaluating stigma. Items are measured on a 7-point Likert Scale, from strongly agree to strongly disagree. | Baseline (0) and 12 months | 
| Effect of participation in C2C on self-management skills | Change from baseline measured by the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65) This measure is a 65-item scale assessing the frequency of use of epilepsy self-management practises. Contains seven domains: 1) healthcare communication, 2) treatment management, 3) coping, 4) social support, 5) seizure tracking, 6) wellness, and 7) seizure response. | Baseline (0) and 12 months | 
| Effect of participation in C2C on quality of life | Change from baseline measured by Quality of Life in Epilepsy Inventory (QOLIE 10), a 10-item scaled evaluating quality of life in adults with epilepsy. Responses range from all of the time to none of the time | Baseline (0) and 12 months | 
| Effect of participation in C2C on epilepsy knowledge | Change from baseline on the Thinking About Epilepsy Questionnaire knowledge subscale. Knowledge is assessed by answering true/false/I don't know | Baseline (0) and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Care Utilization, Emergency Department