title: Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  International Standard Randomised Controlled Trial Number: ISRCTN96895428 version 1.1. Registered on 26 March 2013.
authors.affiliation: Department of Psychiatry, University of Cambridge, Douglas House, 18d Trumpington Road, Cambridge, CB2 8AH, UK. har28@cam.ac.uk.|Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK. har28@cam.ac.uk.|NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK. har28@cam.ac.uk.
authors.forename: Howard
authors.initials: H
authors.lastname: Ring
authors.affiliation: Department of Psychiatry, University of Cambridge, Douglas House, 18d Trumpington Road, Cambridge, CB2 8AH, UK.
authors.forename: Nakita
authors.initials: N
authors.lastname: Gilbert
authors.affiliation: Department of Psychiatry, University of Cambridge, Douglas House, 18d Trumpington Road, Cambridge, CB2 8AH, UK.
authors.forename: Roxanne
authors.initials: R
authors.lastname: Hook
authors.affiliation: Department of Psychiatry, University of Cambridge, Douglas House, 18d Trumpington Road, Cambridge, CB2 8AH, UK.
authors.forename: Adam
authors.initials: A
authors.lastname: Platt
authors.affiliation: Department of Psychiatry, University of Cambridge, Douglas House, 18d Trumpington Road, Cambridge, CB2 8AH, UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Smith
authors.affiliation: School of Health and Population Science, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Irvine
authors.affiliation: Yunus Centre for Social Business and Health, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, UK.
authors.forename: Cam
authors.initials: C
authors.lastname: Donaldson
authors.affiliation: Department of Psychiatry, University of Cambridge, Douglas House, 18d Trumpington Road, Cambridge, CB2 8AH, UK.|Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.|NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Jones
authors.affiliation: King's Clinical Trials Unit, PO64 Institute of Psychiatry, King's College London, De Crespigny Park, London, SE5 8AF, UK.
authors.forename: Joanna
authors.initials: J
authors.lastname: Kelly
authors.affiliation: MRC Biostatistics Unit Hub for Trials Methodology Research, Institute of Public Health, Robinson Way, Cambridge, CB2 0SR, UK.
authors.forename: Adrian
authors.initials: A
authors.lastname: Mander
authors.affiliation: King's Clinical Trials Unit, PO64 Institute of Psychiatry, King's College London, De Crespigny Park, London, SE5 8AF, UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: Murphy
authors.affiliation: Kings Health Economics, PO24, David Goldberg Centre, Institute of Psychiatry Psychology and Neuroscience, Kings College London, De Crespigny Park, London, SE5 8AF, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Pennington
authors.affiliation: Epilepsy Action, New Antsey House, Gate Way Drive, Yeadon, Leeds, LS19 7XY, UK.|NHS Leeds West Clinical Commissioning Group, Suites 2-4, Wira House, Wira Business Park, Leeds, LS16 6EB, UK.
authors.forename: Angela
authors.initials: A
authors.lastname: Pullen
authors.affiliation: Department of Psychiatry, University of Cambridge, Douglas House, 18d Trumpington Road, Cambridge, CB2 8AH, UK.|NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK.
authors.forename: Marcus
authors.initials: M
authors.lastname: Redley
authors.affiliation: NHS Wakefield Clinical Commissioning Group, White Rose House, West Parade, Wakefield, West Yorkshire, WF1 1LT, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Rowe
authors.affiliation: King's Clinical Trials Unit, PO64 Institute of Psychiatry, King's College London, De Crespigny Park, London, SE5 8AF, UK.
authors.forename: James
authors.initials: J
authors.lastname: Wason
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D003625:Data Collection; D004827:Epilepsy / Q000628:therapy*; D006801:Humans; D008607:Intellectual Disability / Q000628:therapy*; D009726:Nurses; D017063:Outcome Assessment, Health Care; D036301:Qualitative Research; D012107:Research Design; D018401:Sample Size
keywords: Clinical trial; Clinical trials unit; Cluster trial; Controlled trial; Cost-effectiveness; Epilepsy; Epilepsy nurse; Intellectual disability; Nurse-led intervention; Pragmatic; Quality of life; Randomised; Treatment; Treatment as usual