Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial

Howard Ring, Nakita Gilbert, Roxanne Hook, Adam Platt, Christopher Smith, Fiona Irvine, Cam Donaldson, Elizabeth Jones, Joanna Kelly, Adrian Mander, Caroline Murphy, Mark Pennington, Angela Pullen, Marcus Ridley, Simon Rowe, James Wason

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Abstract

Background
In adults with intellectual disability (ID) and epilepsy there are suggestions that improvements in management may follow introduction of epilepsy nurse-led care. However, this has not been tested in a definitive clinical trial and results cannot be generalised from general population studies as epilepsy tends to be more severe and to involve additional clinical comorbidities in adults with ID. This trial investigates whether nurses with expertise in epilepsy and ID, working proactively to a clinically defined role, can improve clinical and quality of life outcomes in the management of epilepsy within this population, compared to treatment as usual. The trial also aims to establish whether any perceived benefits represent good value for money.

Methods/design
The EpAID clinical trial is a two-arm cluster randomised controlled trial of nurse-led epilepsy management versus treatment as usual. This trial aims to obtain follow-up data from 320 participants with ID and drug-resistant epilepsy. Participants are randomly assigned either to a ‘treatment as usual’ control or a ‘defined epilepsy nurse role’ active arm, according to the cluster site at which they are treated. The active intervention utilises the recently developed Learning Disability Epilepsy Specialist Nurse Competency Framework for adults with ID. Participants undergo 4 weeks of baseline data collection, followed by a minimum of 20 weeks intervention (novel treatment or treatment as usual), followed by 4 weeks of follow-up data collection. The primary outcome is seizure severity, including associated injuries and the level of distress manifest by the patient in the preceding 4 weeks. Secondary outcomes include cost-utility analysis, carer strain, seizure frequency and side effects. Descriptive measures include demographic and clinical descriptors of participants and clinical services in which they receive their epilepsy management. Qualitative study of clinical interactions and semi-structured interviews with clinicians and participants’ carers are also undertaken.

Discussion
The EpAID clinical trial is the first cluster randomised controlled trial to test possible benefits of a nurse-led intervention in adults with epilepsy and ID. This research will have important implications for ID and epilepsy services. The challenges of undertaking such a trial in this population, and the approaches to meeting these are discussed.

Trial registration
International Standard Randomised Controlled Trial Number: ISRCTN96895428 version 1.1. Registered on 26 March 2013.
Original languageEnglish
JournalTrials
Volume17
DOIs
Publication statusPublished - 24 Jun 2016

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Intellectual Disability
Epilepsy
Randomized Controlled Trials
Nurses
Clinical Trials
Caregivers
Seizures
Population
Therapeutics
Nurse's Role
Learning Disorders
Cost-Benefit Analysis
Comorbidity
Quality of Life
Demography
Interviews

Keywords

  • epilepsy
  • intellectual disability
  • clinical trial

Cite this

Ring, Howard ; Gilbert, Nakita ; Hook, Roxanne ; Platt, Adam ; Smith, Christopher ; Irvine, Fiona ; Donaldson, Cam ; Jones, Elizabeth ; Kelly, Joanna ; Mander, Adrian ; Murphy, Caroline ; Pennington, Mark ; Pullen, Angela ; Ridley, Marcus ; Rowe, Simon ; Wason, James. / Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial. In: Trials. 2016 ; Vol. 17.
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abstract = "BackgroundIn adults with intellectual disability (ID) and epilepsy there are suggestions that improvements in management may follow introduction of epilepsy nurse-led care. However, this has not been tested in a definitive clinical trial and results cannot be generalised from general population studies as epilepsy tends to be more severe and to involve additional clinical comorbidities in adults with ID. This trial investigates whether nurses with expertise in epilepsy and ID, working proactively to a clinically defined role, can improve clinical and quality of life outcomes in the management of epilepsy within this population, compared to treatment as usual. The trial also aims to establish whether any perceived benefits represent good value for money.Methods/designThe EpAID clinical trial is a two-arm cluster randomised controlled trial of nurse-led epilepsy management versus treatment as usual. This trial aims to obtain follow-up data from 320 participants with ID and drug-resistant epilepsy. Participants are randomly assigned either to a ‘treatment as usual’ control or a ‘defined epilepsy nurse role’ active arm, according to the cluster site at which they are treated. The active intervention utilises the recently developed Learning Disability Epilepsy Specialist Nurse Competency Framework for adults with ID. Participants undergo 4 weeks of baseline data collection, followed by a minimum of 20 weeks intervention (novel treatment or treatment as usual), followed by 4 weeks of follow-up data collection. The primary outcome is seizure severity, including associated injuries and the level of distress manifest by the patient in the preceding 4 weeks. Secondary outcomes include cost-utility analysis, carer strain, seizure frequency and side effects. Descriptive measures include demographic and clinical descriptors of participants and clinical services in which they receive their epilepsy management. Qualitative study of clinical interactions and semi-structured interviews with clinicians and participants’ carers are also undertaken.DiscussionThe EpAID clinical trial is the first cluster randomised controlled trial to test possible benefits of a nurse-led intervention in adults with epilepsy and ID. This research will have important implications for ID and epilepsy services. The challenges of undertaking such a trial in this population, and the approaches to meeting these are discussed.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN96895428 version 1.1. Registered on 26 March 2013.",
keywords = "epilepsy, intellectual disability, clinical trial",
author = "Howard Ring and Nakita Gilbert and Roxanne Hook and Adam Platt and Christopher Smith and Fiona Irvine and Cam Donaldson and Elizabeth Jones and Joanna Kelly and Adrian Mander and Caroline Murphy and Mark Pennington and Angela Pullen and Marcus Ridley and Simon Rowe and James Wason",
note = "url (http://rdcu.be/tFLD ) added on request from C.D. 27-6-17 ET Acceptance from webpage Acknowledgements The research was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England at Cambridgeshire and Peterborough NHS Foundation Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.",
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Ring, H, Gilbert, N, Hook, R, Platt, A, Smith, C, Irvine, F, Donaldson, C, Jones, E, Kelly, J, Mander, A, Murphy, C, Pennington, M, Pullen, A, Ridley, M, Rowe, S & Wason, J 2016, 'Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial', Trials, vol. 17. https://doi.org/10.1186/s13063-016-1429-7

Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial. / Ring, Howard; Gilbert, Nakita; Hook, Roxanne; Platt, Adam; Smith, Christopher ; Irvine, Fiona ; Donaldson, Cam; Jones, Elizabeth; Kelly, Joanna ; Mander, Adrian; Murphy, Caroline; Pennington, Mark; Pullen, Angela ; Ridley, Marcus; Rowe, Simon ; Wason, James.

In: Trials, Vol. 17, 24.06.2016.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial

AU - Ring, Howard

AU - Gilbert, Nakita

AU - Hook, Roxanne

AU - Platt, Adam

AU - Smith, Christopher

AU - Irvine, Fiona

AU - Donaldson, Cam

AU - Jones, Elizabeth

AU - Kelly, Joanna

AU - Mander, Adrian

AU - Murphy, Caroline

AU - Pennington, Mark

AU - Pullen, Angela

AU - Ridley, Marcus

AU - Rowe, Simon

AU - Wason, James

N1 - url (http://rdcu.be/tFLD ) added on request from C.D. 27-6-17 ET Acceptance from webpage Acknowledgements The research was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England at Cambridgeshire and Peterborough NHS Foundation Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

PY - 2016/6/24

Y1 - 2016/6/24

N2 - BackgroundIn adults with intellectual disability (ID) and epilepsy there are suggestions that improvements in management may follow introduction of epilepsy nurse-led care. However, this has not been tested in a definitive clinical trial and results cannot be generalised from general population studies as epilepsy tends to be more severe and to involve additional clinical comorbidities in adults with ID. This trial investigates whether nurses with expertise in epilepsy and ID, working proactively to a clinically defined role, can improve clinical and quality of life outcomes in the management of epilepsy within this population, compared to treatment as usual. The trial also aims to establish whether any perceived benefits represent good value for money.Methods/designThe EpAID clinical trial is a two-arm cluster randomised controlled trial of nurse-led epilepsy management versus treatment as usual. This trial aims to obtain follow-up data from 320 participants with ID and drug-resistant epilepsy. Participants are randomly assigned either to a ‘treatment as usual’ control or a ‘defined epilepsy nurse role’ active arm, according to the cluster site at which they are treated. The active intervention utilises the recently developed Learning Disability Epilepsy Specialist Nurse Competency Framework for adults with ID. Participants undergo 4 weeks of baseline data collection, followed by a minimum of 20 weeks intervention (novel treatment or treatment as usual), followed by 4 weeks of follow-up data collection. The primary outcome is seizure severity, including associated injuries and the level of distress manifest by the patient in the preceding 4 weeks. Secondary outcomes include cost-utility analysis, carer strain, seizure frequency and side effects. Descriptive measures include demographic and clinical descriptors of participants and clinical services in which they receive their epilepsy management. Qualitative study of clinical interactions and semi-structured interviews with clinicians and participants’ carers are also undertaken.DiscussionThe EpAID clinical trial is the first cluster randomised controlled trial to test possible benefits of a nurse-led intervention in adults with epilepsy and ID. This research will have important implications for ID and epilepsy services. The challenges of undertaking such a trial in this population, and the approaches to meeting these are discussed.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN96895428 version 1.1. Registered on 26 March 2013.

AB - BackgroundIn adults with intellectual disability (ID) and epilepsy there are suggestions that improvements in management may follow introduction of epilepsy nurse-led care. However, this has not been tested in a definitive clinical trial and results cannot be generalised from general population studies as epilepsy tends to be more severe and to involve additional clinical comorbidities in adults with ID. This trial investigates whether nurses with expertise in epilepsy and ID, working proactively to a clinically defined role, can improve clinical and quality of life outcomes in the management of epilepsy within this population, compared to treatment as usual. The trial also aims to establish whether any perceived benefits represent good value for money.Methods/designThe EpAID clinical trial is a two-arm cluster randomised controlled trial of nurse-led epilepsy management versus treatment as usual. This trial aims to obtain follow-up data from 320 participants with ID and drug-resistant epilepsy. Participants are randomly assigned either to a ‘treatment as usual’ control or a ‘defined epilepsy nurse role’ active arm, according to the cluster site at which they are treated. The active intervention utilises the recently developed Learning Disability Epilepsy Specialist Nurse Competency Framework for adults with ID. Participants undergo 4 weeks of baseline data collection, followed by a minimum of 20 weeks intervention (novel treatment or treatment as usual), followed by 4 weeks of follow-up data collection. The primary outcome is seizure severity, including associated injuries and the level of distress manifest by the patient in the preceding 4 weeks. Secondary outcomes include cost-utility analysis, carer strain, seizure frequency and side effects. Descriptive measures include demographic and clinical descriptors of participants and clinical services in which they receive their epilepsy management. Qualitative study of clinical interactions and semi-structured interviews with clinicians and participants’ carers are also undertaken.DiscussionThe EpAID clinical trial is the first cluster randomised controlled trial to test possible benefits of a nurse-led intervention in adults with epilepsy and ID. This research will have important implications for ID and epilepsy services. The challenges of undertaking such a trial in this population, and the approaches to meeting these are discussed.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN96895428 version 1.1. Registered on 26 March 2013.

KW - epilepsy

KW - intellectual disability

KW - clinical trial

U2 - 10.1186/s13063-016-1429-7

DO - 10.1186/s13063-016-1429-7

M3 - Article

VL - 17

ER -