Plain English Summary
Background and study aims
Epilepsy is a condition that affects the brain and causes seizures. Epilepsy surgery is recommended for people with epilepsy (PWE) whose seizures cannot be managed by antiepileptic drugs (AEDs). The aim of this study is to examine how different groups of PWE drawn from the same group of repeat emergency department (ED) attenders fare when the NICE Guideline care pathways for people with epilepsy is applied to them. PWE will be in one of four groups:
1. Those who follow the surgical pathway, including vagus nerve stimulation (VNS) treatment
2. Those who have a change of medication to 3rd generation antiepileptic medication
3. Those who have no change initially but are followed up in specialist care
4. Those who do not engage with specialist services offered
The researchers propose to look at people’s quality of life in each group, including a quarterly review of medical records looking at changes to seizure frequency and type, ED attendance, tolerance, compliance and use of rescue medications.
Who can participate?
Patients aged over 18 who have attended the Royal Cornwall Hospital (Treliske) ED at least twice between 2018-2018 and have not been seen since 01/01/2019 by an epilepsy specialist
What does the study involve?
Participants complete a set of questionnaires including a quality of life questionnaire and the Connect Epilepsy tool. This will be completed at the start of the study and quarterly for 1 year after. Each participant's medical records will be accessed for ED attendance, use of rescue medications, paramedic attendance, and side effects. Each group will be offered treatments as per routine clinical practice and choice:
Group 1: PWE eligible for surgery: This group will be referred to a tertiary centre (Bristol) for suitable assessment and surgery. PWE may receive 3rd generation AEDs while their decision for surgery awaits confirmation.
Group 2: PWE either is ineligible for surgery or choose not to be referred for one. PWE undergo a second assessment for most beneficial AED. They might receive 3rd Generation AEDs.
Group 3: PWE refuses surgery and/or change in medication. This group's treatment plan does not change but continue to see epilepsy specialists.
Group 4: PWE who do receive treatment change and are unwilling to engage with specialist services. However, patient admissions to ED will be recorded.
Each group's medical records will be reviewed on a quarterly basis for the above-described data for 1 year and exit interviews are conducted.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement in their quality of life.
Where is the study run from?
Royal Cornwall Hospital (Treliske) and Cornwall Partnership NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2019 to September 2022
Who is funding the study?
Liva Nova Inc. (USA)
Who is the main contact?
Sarah Lennard
sarah.lennard@nhs.net
Trial website
Contact information
Type
Public
Primary contact
Mrs Sarah Lennard
ORCID ID
http://orcid.org/0000-0001-9033-6752
Contact details
The Kernow Building
Wilson Way
Pool
Pool
TR15 3QE
United Kingdom
+44 (0)1209 204020
sarah.lennard@nhs.net
Type
Scientific
Additional contact
Dr Rohit Shankar
ORCID ID
http://orcid.org/0000-0002-1183-6933
Contact details
Carew House
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
+44 (0)1208 834455
rohit.shankar@nhs.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Version 2.0, IRAS 272686
Study information
Scientific title
Pharmacoresistant epilepsy treatment options & quality of life V1
Acronym
Study hypothesis
The aim of the study is to examine how different groups of PWE drawn from the same cohort of being repeat ED attenders fare when the NICE Guideline care pathways for people with epilepsy is applied to them. PWE will be in one of four groups:
1. Those who follow the surgical pathway, including VNS
2. Those that have a change of medication to 3rd generation antiepileptic medication
3. Those that have no change initially but are followed up in specialist care
4. Those that do not engage with specialist services offered
The researchers propose to look at people’s quality of life in each group, including a quarterly review of medical records looking at changes to seizure frequency and type, ED attendance, tolerance, compliance and use of rescue medications.
Ethics approval
Approved 11/06/2020, London - Camberwell St Giles Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)2071048103; camberwellstgiles.rec@hra.nhs.uk), REC ref: 20/LO/0700
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Pharmacoresistant epilepsy in adults
Intervention
Stage 1: Treatment Plan
An epilepsy specialist will review an identified cohort of PWE (serial no-attenders to ED). Reviewed PWE will be divided into four groups depending on the assessor's recommendations and PWE engagement and treatment choice.
Stage 2: Pre-Treatment Questionnaire
All consenting PWE will complete a set of questionnaires before beginning their treatment and at their reviews. Information on side effects, medication effectiveness, compliance, Emergencies (ED, paramedic attendance, rescue medication), risk assessments (Sudden Unexpected Death in Epilepsy (SUDEP) & Seizure Safety Checklist) and quality of Life (QOL) scales (QOLIE-31 and Connect Epilepsy tool)
Step 3: Treatments
Each group will be offered treatments as per routine clinical practice and choice:
Group 1: PWE eligible for surgery: This group will be referred to a tertiary centre (Bristol) for suitable assessment and surgery. PWE may receive 3rd generation AEDs while their decision for surgery awaits confirmation.
Group 2: PWE either is ineligible for surgery or choose not to be referred for one. PWE undergo a second assessment for most beneficial AED. They might receive 3rd Generation AEDs.
Group 3: PWE refuses surgery and/or change in medication. This group's treatment plan does not change but continue to see epilepsy specialists.
Group 4: PWE who do receive treatment change and are unwilling to engage with specialist services. However, patient admissions to ED will be recorded.
Step 4: Follow Up
Each group's medical records will be reviewed on a quarterly basis for the above-described data collection for 1 year, QOL questionnaires will also be completed quarterly for 1 year together with exit interviews for QOL scales conducted for those in groups 1-3.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Quality of life measured using QOLIE-31 at baseline then quarterly for 1 year
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/01/2019
Overall trial end date
01/09/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Diagnosis of epilepsy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
Unable to give consent
Recruitment start date
01/09/2020
Recruitment end date
01/09/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cornwall Partnership NHS Foundation Trust
Carew House
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
Sponsor information
Organisation
Cornwall Partnership NHS Foundation Trust
Sponsor details
The Kernow Building
Wilson Way
Pool
Redruth
TR15 3QE
United Kingdom
+44 (0)1209 204020
cpn-tr.cftresearch@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Liva Nova USA Inc.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Planned publication of the protocol
2. Initial publication following audit due for publication by the end of 2020
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/12/2020
Participant level data
Other
Basic results (scientific)
Publication list