Clinical trial NCT04248920: Clinic to Community© Program for Adults With Epilepsy Admitted to Emergency Departments
Official title: Clinic to Community© Program for Adults With Epilepsy Admitted to Emergency Departments: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy, Generalized
Keywords: Health Care Utilization
Emergency Department
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ontario Brain Institute
First posted: 2020-01-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Adults (aged ≥18 years) visiting a participating ED for a seizure or an epilepsy-related concern.
2. Adults on anti-seizure medication prior to coming to the ED or prescribed anti-seizure medication at the ED.
3. Providing informed consent and having sufficient English language skills to complete questionnaires and participate in the intervention.

Exclusion Criteria:

1. Previous participation in the C2C program.
2. Known diagnosis of psychogenic non-epileptic seizures (PNES).

Primary outcomes:
measure: Rate of engagement with the Clinic To Community© (C2C) program
timeFrame: Throughout study completion, approximately 2 years
Secondary outcomes:
measure: Frequency of epilepsy-related emergency department (ED) visits over the next 12 months
timeFrame: Baseline (0), and 12 months
measure: Effect of participation in C2C on felt stigma using "Stigma Scale of Epilepsy"
timeFrame: Baseline (0) and 12 months
measure: Effect of participation in C2C on felt stigma using "Epilepsy Stigma Scale"
timeFrame: Baseline (0) and 12 months
measure: Effect of participation in C2C on self-management skills
timeFrame: Baseline (0) and 12 months
measure: Effect of participation in C2C on quality of life
timeFrame: Baseline (0) and 12 months
measure: Effect of participation in C2C on epilepsy knowledge
timeFrame: Baseline (0) and 12 months
Other outcomes:
measure: Effect on quality of life using World Health Organization Quality of Life (WHOQOL)
timeFrame: Baseline (0) and 12 months
measure: Effect on activities of daily living using Sheehan Disability Scale
timeFrame: Baseline (0) and 12 months
measure: Effect on anxiety using Generalized Anxiety Disorder 7-item (GAD-7) scale
timeFrame: Baseline (0) and 12 months
measure: Effect on depressive symptoms based on Quick Inventory of Depressive Symptomatology
timeFrame: Baseline (0) and 12 months
measure: Effect on sleep quality using Pittsburgh Sleep Quality Index (25-items)
timeFrame: Baseline (0) and 12 months
measure: Effect on suicide ideation using Columbia-Suicide Severity Rating Scale (C-SSRS) Screener
timeFrame: Baseline (0) and 12 months
measure: Effect on Psychiatric comorbidities using Brief Symptom Inventory
timeFrame: Baseline (0) and 12 months
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Kathy N Speechley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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