- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04248920
Clinic to Community© Program for Adults With Epilepsy Admitted to Emergency Departments (C2CEDRCT)
Clinic to Community© Program for Adults With Epilepsy Admitted to Emergency Departments: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mary Secco
- Phone Number: (519) 433-4073
- Email: msecco@uwo.ca
Study Contact Backup
- Name: Kathy Speechley, PhD
- Phone Number: 52182 519-685-8500
- Email: kspeechl@uwo.ca
Study Locations
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Ontario
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
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.
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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).
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Other: Waitlist Control Group
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.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of engagement with the Clinic To Community© (C2C) program
Time Frame: Throughout study completion, approximately 2 years
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Evaluated by rate of ED referrals, rate of recruitment, rate of retention, and proportion who receive support education.
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Throughout study completion, approximately 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of epilepsy-related emergency department (ED) visits over the next 12 months
Time Frame: Baseline (0), and 12 months
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Change from baseline in frequency of ED visits and health care utilization, adapted from the Canadian Community Health Survey
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Baseline (0), and 12 months
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Effect of participation in C2C on felt stigma using "Stigma Scale of Epilepsy"
Time Frame: Baseline (0) and 12 months
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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
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Effect of participation in C2C on felt stigma using "Epilepsy Stigma Scale"
Time Frame: Baseline (0) and 12 months
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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".
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Baseline (0) and 12 months
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Effect of participation in C2C on self-management skills
Time Frame: Baseline (0) and 12 months
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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.
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Baseline (0) and 12 months
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Effect of participation in C2C on quality of life
Time Frame: Baseline (0) and 12 months
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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"
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Baseline (0) and 12 months
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Effect of participation in C2C on epilepsy knowledge
Time Frame: Baseline (0) and 12 months
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Change from baseline on the "Thinking About Epilepsy Questionnaire" knowledge subscale.
Knowledge is assessed by answering true/false/I don't know
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Baseline (0) and 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect on quality of life using World Health Organization Quality of Life (WHOQOL)
Time Frame: Baseline (0) and 12 months
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Change from baseline measured by World Health Organization Quality of Life (WHOQOL) - Abbreviated (BREF), 30-item measure of quality of life, generic-HRQOL instrument.
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Baseline (0) and 12 months
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Effect on activities of daily living using Sheehan Disability Scale
Time Frame: Baseline (0) and 12 months
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Change from baseline measured by the Sheehan Disability Scale is 5-items for patient-rated measure of disability and impairment.
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Baseline (0) and 12 months
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Effect on anxiety using Generalized Anxiety Disorder 7-item (GAD-7) scale
Time Frame: Baseline (0) and 12 months
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Change from baseline using the Generalized Anxiety Disorder 7-item (GAD-7) scale, 7-item scale evaluating generalized anxiety.
Generates an overall anxiety score, with scores above 10 indicative of moderate-severe anxiety.
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Baseline (0) and 12 months
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Effect on depressive symptoms based on Quick Inventory of Depressive Symptomatology
Time Frame: Baseline (0) and 12 months
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Change from baseline using the Quick Inventory of Depressive Symptomatology, 14-item scale evaluating depressive symptoms.
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Baseline (0) and 12 months
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Effect on sleep quality using Pittsburgh Sleep Quality Index (25-items)
Time Frame: Baseline (0) and 12 months
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Change from baseline measured by the Pittsburgh Sleep Quality Index, 25-item scale evaluating sleep quality.
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Baseline (0) and 12 months
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Effect on suicide ideation using Columbia-Suicide Severity Rating Scale (C-SSRS) Screener
Time Frame: Baseline (0) and 12 months
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Change from baseline measured by the C-SSRS Screener, a 6-item scale evaluating suicidal ideation.
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Baseline (0) and 12 months
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Effect on Psychiatric comorbidities using Brief Symptom Inventory
Time Frame: Baseline (0) and 12 months
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Change from baseline measured by 53-items covering nine symptom dimensions: Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation and Psychoticism; and three global indices of distress: Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total.
The global indices measure current or past level of symptomatology, intensity of symptoms, and number of reported symptoms, respectively
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Baseline (0) and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathy N Speechley, PhD, London Health Sciences Centre
Publications and helpful links
General Publications
- Bautista RE, Glen ET, Wludyka PS, Shetty NK. Factors associated with utilization of healthcare resources among epilepsy patients. Epilepsy Res. 2008 May;79(2-3):120-9. doi: 10.1016/j.eplepsyres.2008.01.003. Epub 2008 Mar 12.
- Bowen JM, Snead OC, Chandra K, Blackhouse G, Goeree R. Epilepsy care in ontario: an economic analysis of increasing access to epilepsy surgery. Ont Health Technol Assess Ser. 2012;12(18):1-41. Epub 2012 Jul 1.
- Couldridge L, Kendall S, March A. A systematic overview--a decade of research'. The information and counselling needs of people with epilepsy. Seizure. 2001 Dec;10(8):605-14. doi: 10.1053/seiz.2001.0652.
- Noble AJ, Mathieson A, Ridsdale L, Holmes EA, Morgan M, McKinlay A, Dickson JM, Jackson M, Hughes DA, Goodacre S, Marson AG. Developing patient-centred, feasible alternative care for adult emergency department users with epilepsy: protocol for the mixed-methods observational 'Collaborate' project. BMJ Open. 2019 Nov 2;9(11):e031696. doi: 10.1136/bmjopen-2019-031696.
- Kapoor, Deepa, Joubert, Gary, Thind, Amardeep, Secco, Mary, Speechley, Kathy Nixon. Number of Potentially Deferrable Patients Presenting to Emergency Departments in London with Seizures. Epilepsia 2007; Vol 48, Supplement 6
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This study is partnered with the Ontario Brain Institute (OBI). Study data and other personal health information collected as a part of this research study will be shared with the Ontario Brain Institute. OBI is a not-for profit research institute that funds people to work together to find cures and better treatments for brain disorders. It includes not just doctors and researchers but patients, members of the medical community, government and other health-related organizations. This database of research data is known as 'Brain-CODE'.
Brain-CODE is an open-access database. This means that researchers and organizations outside of this study can request access to study data that is in the Brain-CODE database. OBI may take data, combine it with data from many other people, and make it available to enhance the public's awareness of research. They will use tools to remove identifying information from these combined data sets, making the risk of identifiers minimal.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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