Training nurses in a competency framework to support adults with epilepsy and intellectual disability: the EpAID cluster RCT.
Type of research:
Experimental investigation followed by a clinical trial
People with an intellectual (learning) disability (ID) and epilepsy have an increased seizure frequency, higher frequencies of multiple antiepileptic drug (AED) use and side effects, higher treatment costs, higher mortality rates and more behavioural problems than the rest of the population with epilepsy. The introduction of nurse-led care may lead to improvements in outcome for those with an ID and epilepsy; however, this has not been tested in a definitive clinical trial.
The aim of this research was to determine whether or not ID nurses, using a competency framework developed to optimise nurse management of epilepsy in people with an ID, can cost-effectively improve clinical and quality-of-life outcomes in the management of epilepsy compared with treatment as usual.
The study was a cluster randomised controlled trial (RCT) with two arms: a TAU control arm and an experimental arm involving the use of the ID epilepsy nurse competency framework. The trial complied with the Consolidated Standards of Reporting Trials (CONSORT) guidelines for cluster randomised trials. The study also contained a nested qualitative component. A cluster randomised design was selected because the intervention, a change in how nurses worked within the community team setting, needed to be implemented at the level of the clinical team as a whole. This was because, first, pilot work had previously indicated that within a community team the nurses would share duties from time to time and therefore all would need to follow the same treatment approach and, second, as the active intervention also involved training of the nurses administering it, those nurses could no longer be considered to be able to continue to deliver TAU reliably. The trial was therefore developed such that a community team constituted a single cluster.
The research involved collaboration within Cambridge from the University of Cambridge Depart of Engineering, the MRC Cognition and Brain Sciences Unit and the Addenbrookes Hospital Depart of Clinical Engineering. The research also involved collaboration with clinical staff in Hertfordshire and an academic at the University of East Anglia. The research involved the development of collaboration with an industry partner; Rescon Ltd – a research, development and consulting company with a focus on solving complex biomedical systems problems relating to human performance.
Epilepsy Action – the largest UK epilepsy charity – which acts to represent the interests of people with epilepsy and their families and carers collaborated, and Patient and Public (PPI) involvement was obtained from the NIHR Research Design Service for the East of England, University of Essex.
Key findings and outputs:
In total, 312 individuals were recruited into the study from 17 research clusters. Using an intention-to-treat analysis controlling for baseline individual-level and cluster-level variables there was no significant difference in seizure severity score between the two arms. Altogether, 238 complete cases were included in the non-imputed primary analysis. Analyses of the secondary outcomes revealed no significant differences between arms. A planned subgroup analysis identified a significant interaction between treatment arm and level of ID. There was a suggestion in those with mild to moderate ID that the competency framework may be associated with a small reduction in concerns over seizure severity (standard error 2.005, 95% confidence interval –0.554 to 7.307; p = 0.092). However, neither subgroup showed a significant intervention effect individually. Family members’ perceptions of nurses’ management depended on the professional status of the nurses, regardless of trial arm. Economic analysis suggested that the competency framework intervention was likely to be cost-effective, primarily because of a reduction in the costs of supporting participants compared with treatment as usual.
Overall, for adults with an ID and epilepsy, the framework conferred no clinical benefit compared with usual treatment. The economic analysis suggested that there may be a role for the framework in enhancing the cost-effectiveness of support for people with epilepsy and an ID. Future research could explore the specific value of the competency framework for those with a mild to moderate ID and the potential for greater long-term benefits arising from the continuing professional development element of the framework.
- Ring H, Howlett J, Pennington M, Smith C, Redley M, Murphy C, et al. Training nurses in a competency framework to support adults with epilepsy and intellectual disability: the EpAID cluster RCT. Health Technol Assess 2018;22(10). https://doi.org/10.3310/hta22100
For further information on this project, contact Dr Howard Ring, Cambridge Intellectual and Developmental Disabilities Research Group, University of Cambridge; firstname.lastname@example.org