Department of Psychiatry, University of Cambridge, Cambridge, UK.
Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.
Health Technol Assess. 2018 Feb;22(10):1-104. doi: 10.3310/hta22100.
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.
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.
Cluster-randomised two-arm trial.
Community-based secondary care delivered by members of community ID teams.
Participants were adults aged 18-65 years with an ID and epilepsy under the care of a community ID team and had had at least one seizure in the 6 months before the trial.
The experimental intervention was the Learning Disability Epilepsy Specialist Nurse Competency Framework. This provides guidelines describing a structure and goals to support the delivery of epilepsy care and management by ID-trained nurses.
The primary outcome was the seizure severity scale from the Epilepsy and Learning Disabilities Quality of Life questionnaire. Measures of mood, behaviour, AED side effects and carer strain were also collected. A cost-utility analysis was undertaken along with a qualitative examination of carers' views of participants' epilepsy management.
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; = 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.
The intervention could not be delivered blinded. Treatment as usual varied widely between the research sites.
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.
Current Controlled Trials ISRCTN96895428.
This trial was funded by the NIHR Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 10. See the NIHR Journals Library website for further project information.
与普通癫痫人群相比，智力障碍（学习）患者癫痫发作频率更高，抗癫痫药物（AED）的使用种类更多，副作用发生率更高，治疗费用更高，死亡率更高，且更易出现行为问题。引入护士主导的护理模式可能会改善智力障碍伴癫痫患者的预后；然而，这尚未在确定性临床试验中得到验证。
确定以专门开发的、旨在优化智力障碍患者癫痫管理的 ID 护士能力框架为指导，能否在改善临床和生活质量结局方面，相较于常规治疗，为癫痫管理带来成本效益。
以社区为基础的二级医疗保健，由社区 ID 团队的成员提供。
参与者为年龄在 18 至 65 岁之间、有社区 ID 团队护理的智力障碍成人患者，且在试验前 6 个月内至少有一次癫痫发作。
实验组的干预措施是学习障碍癫痫专科护士能力框架。该框架提供了指导说明，描述了结构和目标，以支持经过 ID 培训的护士提供癫痫护理和管理。
主要结局测量指标是来自癫痫和学习障碍生活质量问卷的癫痫严重程度量表。还收集了情绪、行为、AED 副作用和照顾者负担的测量指标。进行了成本-效用分析，并对照顾者对参与者癫痫管理的看法进行了定性检查。
从 17 个研究小组中总共招募了 312 名个体参加研究。采用意向治疗分析，控制基线个体和小组水平的变量，两组间的癫痫严重程度评分无显著差异。总共纳入了 238 名完整的病例进行未插补的主要分析。对次要结局的分析显示，两组之间没有显著差异。一项计划的亚组分析发现，治疗组与智力障碍程度之间存在显著的交互作用。在轻度至中度智力障碍患者中，能力框架可能与对癫痫严重程度的担忧略有减少有关（标准误 2.005，95%置信区间-0.554 至 7.307； = 0.092）。然而，亚组均未单独显示出显著的干预效果。家庭成员对护士管理的看法取决于护士的专业地位，而与试验分组无关。经济分析表明，能力框架干预可能具有成本效益，主要是因为与常规治疗相比，支持参与者的成本降低。
干预措施无法进行盲法评估。常规治疗在各研究地点之间差异很大。
总的来说，对于智力障碍伴癫痫的成年人，与常规治疗相比，该框架没有带来临床获益。经济分析表明，对于增强癫痫和智力障碍患者支持的成本效益，该框架可能具有一定作用。未来的研究可以探索能力框架对于轻度至中度智力障碍患者的具体价值，以及框架中持续专业发展要素可能带来的长期获益。
当前对照试验 ISRCTN96895428。
本试验由英国国家卫生与临床优化研究所卫生技术评估计划资助，全文将在；第 22 卷，第 10 期发表。请访问英国国家卫生与临床优化研究所期刊图书馆网站以获取更多项目信息。
