Title: Improving outcomes in adults with epilepsy and intellectual disability: Acluster randomised controlled trial of nurse-led epilepsy management (EpAID)
Funder: Department of Health (England)

Abstract: 1. Design: A cluster randomized trial with two arms; a ‘treatment as usual’ control and a ‘defined epilepsy nurse (EN) role’ active arm complying with CONSORT guidelines for cluster randomized trials. In twelve research sites a random selection of 34 eligible individuals will be recruited (applying the Mental Capacity Act 2005 where required). Sites will be randomly allocated to either arm. Assessments will be at baseline and after 6 months treatment by researchers blind to treatment arm nature of the interventions and study hypothesis. Service user group input will inform study design.2. Health technology: A nurse (EN) with skills in management of epilepsy in adults with ID working according to Royal College of Nursing Competencies for ENs. ENs randomized to the active arm will be trained in the experimental intervention. All ENs will have their clinical practice during the trial monitored using established methods which will also define any local variations in control treatment. The active treatment comprises: A. Relationship with patient and carers / paid support workers- Assessing the patient on a regular basis at a frequency determined by clinical need.- Providing epilepsy education to patient and carers / paid support workers.- Being point of first contact for service user / carer – initiated calls and available for phone contacts during the regular working week.- Providing management where indicated in line with the EN Competencies document. B. Relationship with other clinicians- Facilitating and informing communication with other health services as required.3. Research Setting: Community ID teams in the United Kingdom.4. Target population: Adults (aged > 17 years) with ID and epilepsy under the care of a community ID team with an average of at least one seizure per month over the three months prior to entry into the study.5. Sample size: Sample sizes have been calculated on the basis of a provisional estimation of intra-class correlation coefficient (ICC) derived from a preliminary characterisation of 91 adults with ID and epilepsy followed for 6 months using instruments that will comprise the primary outcome measures in this study. The true ICC was considered likely to lie in the range 0-0.1. For two primary outcomes using a two-sided significance level of 0.025 (i.e. accounting for multiple testing) with 30 patients per cluster six clusters per arm and an estimated ICC of 0.05 the study will have a power of approximately 90% to detect a difference between the study arms of 4.2 in the ELDQOL seizure severity scale. We consider this to be a clinically meaningful difference. We will recruit 34 patients per cluster allowing for an attrition rate of 11%. 6. Outcomes.6a. Measurement of outcomes: Each participant and a carer / paid support worker will be visited 4 times by a researcher; Visit 1 to prepare for base-line data collection. Visit 2 (one month later) to collect base-line data. Visit 3 (six months after visit 2) to prepare for outcome data collection. Visit 4 (one month later) to collect outcome data. Visits will collect descriptive clinical and demographic data.6b. Primary Outcome: Sseizure severity assessed using the seizure severity scale from the Epilepsy in Learning Disabilities Quality of Life (ELDQOL-SSS) instrument.6c. The trial will employ the following assessments: The ELDQOL to assess seizure severity and quality of life. The EQ-5D to in conjunction with other data collected calculate QALYs to permit comparison with the primary outcome measure (ELDQOL) in terms of sensitivity to change. We will also use the EQ-5D to assess carers concerns for the patient and the Caregiver Strain Index to assess effects of the intervention on carers. Health and social care activities and costs will be collected using the Client Service Resource Inventory. 6d. Qualitative assessments - Semi-structured interviews will be conducted with samples of: i) Clinicians - addressing therapeutic relations with respect to paid and family carers and patients’ medical and wider best interests. ii) Family-carers - addressing relations with clinicians; identifying and advocating for the patient’s wishes in clinical consultations and the needs of the patient in the context of the family’s needs; and iii) paid carers - addressing relations with clinicians and family carers (where involved) and how they operationalise ‘duty of care’ when faced with the uncertainties of epilepsy treatment. A sample of 10 of each group in each arm will be interviewed.6e. Economic outcomes - These will include a cost-utility analysis and carer preferences identified by willingness to pay methods. As part of this economic evaluation clinical demands on other health agencies – including GP community ID team Accident and Emergency and neurology services will be determined with data recorded using the Client Service Receipt Inventory over the final two months of participation in the trial. Mean willingness-to-pay values for each service will provide a measure of the strength of preference across the two service options collected after six months in the trial.7. Statistical analysis will use linear mixed-effect models to account for clustering. 8. Project timetable: Total study duration = 32 months.Months 1-8: Preparation and recruitment of researchers and clusters (a research associate recruited at start of month 1 three research assistants recruited to start at month 9). Service User focus groups.Month 9:Train research assistants.Month 10:Start collecting base-line observations. Month 12:Intervention commences.End of month 19:3 clusters completed.End of month 21:6 clusters completed.End of month 23:9 clusters completed.End of month 25:10 clusters completed.Months 24-25:Qualitative assessments.Month 26: Complete qualitative assessments and delayed follow-ups.Months 26-32:Data analysis and dissemination.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: NEUROLOGICAL