Epilepsy, GeneralizedC2CEDRCTNCT04248920
Clinic to Community© Program for Adults With Epilepsy Admitted to Emergency Departments
A study testing Clinic to Community Education Program in people with Epilepsy, Generalized, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Generalized
- What is being tested?
- Clinic to Community Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 12 Sep 2022to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous participation in the C2C program.
- Known diagnosis of psychogenic non-epileptic seizures (PNES).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinic to Community© Program for Adults With Epilepsy Admitted to Emergency Departments: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Epilepsy, Generalized
- Being tested
- Clinic to Community Education Program
- Keywords
- Health Care Utilization, Emergency Department
- Medical subject headings
- Epilepsy, Generalized, Patient Acceptance of Health Care, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic to Community Education ProgramBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Clinic to Community Education Program |
| Waitlist Control Group | Other | 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. Receives: Behavioral: Clinic to Community Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout study completion, approximately 2 years
Secondary outcomes (6)
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
Measured: 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).
Measured: 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".
Measured: 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.
Measured: 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"
Measured: 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
Measured: Baseline (0) and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start12 Sep 2022
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, GeneralizedStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Brain Institute
- Responsible party
- Sponsor
- Investigators
- Kathy N Speechley, PhD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248920
- Sponsor's protocol ID
- 9045
- Acronym
- C2CEDRCT
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2020
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 18339521Bowen 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.
PubMed 23074428Couldridge 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.
PubMed 11792167Noble 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.
PubMed 31678950Kapoor, 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 at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic to Community© Program for Adults With Epilepsy Admitted to Emergency Departments: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04248920
- Acronym / sponsor ID
- C2CEDRCT / 9045
- Conditions
- Epilepsy, Generalized
- Keywords
- Health Care Utilization, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Ontario Brain Institute
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Clinic to Community Education ProgramIntervention 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. |
| Waitlist Control Group | Other | Behavioral: Clinic to Community Education ProgramWaitlist 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Previous participation in the C2C program.
- Known diagnosis of psychogenic non-epileptic seizures (PNES).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinic to Community Education ProgramThe 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). | Behavioural | Intervention Group, Waitlist Control Group |
Primary outcome
Rate of engagement with the Clinic To Community© (C2C) program
Time frame: Throughout study completion, approximately 2 years
Evaluated by rate of ED referrals, rate of recruitment, rate of retention, and proportion who receive support education.
6 secondary outcomes
Frequency of epilepsy-related emergency department (ED) visits over the next 12 months
Time frame: Baseline (0), and 12 months
Effect of participation in C2C on felt stigma using "Stigma Scale of Epilepsy"
Time frame: Baseline (0) and 12 months
Effect of participation in C2C on felt stigma using "Epilepsy Stigma Scale"
Time frame: Baseline (0) and 12 months
Effect of participation in C2C on self-management skills
Time frame: Baseline (0) and 12 months
Effect of participation in C2C on quality of life
Time frame: Baseline (0) and 12 months
Effect of participation in C2C on epilepsy knowledge
Time frame: Baseline (0) and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 18339521Bautista 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.
- Background: PubMed 23074428Bowen 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.
- Background: PubMed 11792167Couldridge 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.
- Background: PubMed 31678950Noble 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.
- BackgroundKapoor, 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
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy N Speechley, PhD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic to Community Education Program in people with Epilepsy, Generalized, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of engagement with the Clinic To Community© (C2C) program (time frame: Throughout study completion, approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04248920, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.