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

NCT04248920 | Completed

• 1 other identifier: 9045
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Generalized

Keywords

Health Care Utilization; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Frequency of epilepsy-related emergency department (ED) visits over the next 12 months

  Baseline (0), and 12 months

• Effect of participation in C2C on felt stigma using "Stigma Scale of Epilepsy"

  Baseline (0) and 12 months

• Effect of participation in C2C on felt stigma using "Epilepsy Stigma Scale"

  Baseline (0) and 12 months

• Effect of participation in C2C on self-management skills

  Baseline (0) and 12 months

• Effect of participation in C2C on quality of life

  Baseline (0) and 12 months

Other Outcomes (7)

• Effect on quality of life using World Health Organization Quality of Life (WHOQOL)

  Baseline (0) and 12 months

• Effect on activities of daily living using Sheehan Disability Scale

  Baseline (0) and 12 months

• Effect on anxiety using Generalized Anxiety Disorder 7-item (GAD-7) scale

  Baseline (0) and 12 months

Study Arms (2)

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.

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.

Behavioral: Clinic to Community Education Program

Interventions

Clinic to Community Education Program BEHAVIORAL

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).

Intervention Group; Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Ontario Brain Institute: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (5)

• 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.

  PMID: 18339521 BACKGROUND

• 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.

  PMID: 23074428 BACKGROUND

• 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.

  PMID: 11792167 BACKGROUND

• 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.

  PMID: 31678950 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Epilepsy, Generalized; Patient Acceptance of Health Care; Emergencies

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathy N Speechley, PhD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is not feasible for participants and study personnel to be blinded. However, the letter of information (LOI) indicates that the study aims to evaluate outcomes after an ED visit, and, in addition, evaluate the impact of a community engagement program.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 30, 2020
• Study Start: September 12, 2022
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Data will be stored in BrainCODE indefinitely
• Access Criteria: Access to data by outside researchers or organizations will require a detailed plan for the use of the data, and approval from a research ethics board, as described in OBI's Data Sharing Policy http://www.braininstitute.ca/Brain-CODE-governance. These researchers or organizations will be required to enter into an agreement with OBI that clearly states the safeguards that will be in place to protect that data, and the purposes for which this data may be collected, used, stored and disclosed.

Locations

CA (1)