Stanyard Emily, Neilens Helen, Allgar Victoria, Bailey Matthew, Musicha Crispin, Purandare Kiran, Perera Bhathika, Roy Ashok, Sawhney Indermeet, Watkins Lance, Jaydeokar Sujeet, Lennard Sarah, Mitchell Sarah, McGowan Paula, Laugharne Richard, Tromans Samuel J, Shankar Rohit
Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, United Kingdom.
Medical Statistics Group, University of Plymouth, Plymouth, United Kingdom.
Front Health Serv. 2025 May 9;5:1393805. doi: 10.3389/frhs.2025.1393805. eCollection 2025.
The stopping overmedication of people with a learning disability, autism, or both (STOMP) programme was launched in 2016 in response to concerns about the over-prescribing of medication in people with intellectual disability. The programmes focus has been on the withdrawal of antipsychotic treatment for the individual person than the service or dosage optimisation. It could be that cumulative service level antipsychotic treatment converted and presented as chlorpromazine units could allow for comparison of services on how antipsychotic treatment is being utilised and allow for comparing of practices between services in different regions. The aim of this feasibility study is to explore if cumulative service scores of antipsychotic treatment burden could define prescribing patterns across different specialist intellectual disability services in England and Wales, focused on those on ≥2 antipsychotic treatments. There is no evidence to use ≥2 antipsychotic treatments for any individual.
The study is a feasibility cross-sectional study investigating service antipsychotic treatment cumulative burden at seven annual time points, 2017-2023. De-identified data for adult patients with intellectual disability under the care of specialist intellectual disability services in receipt of ≥2 oral and/or long-acting IM (intramuscular) injectable (depot) antipsychotic treatments are included. Demographic and clinical data will be collated, in addition to information on the prescribed antipsychotic treatments. The data will be evaluated for data completeness and will be inputted into the Statistical Process Control tool. Outcomes will be measured using a combination of methods including descriptive analysis (including mean, standard deviation and percentage values), and a mixed effects regression model, to determine changes in chlorpromazine equivalent dose values over time.
Seven England and Wales National Health Service intellectual disability services are recruiting up to 490 people. There were recognised challenges in identifying the relevant eligible cohort across services and administering a common set of outcome measures.
This study is intended to inform decisions to design a wider registry that would involve antipsychotic treatment prescribing data for patients across multiple sites nationwide. Developing a de-identified database using routinely collected data, without the requirement for informed consent, comes with unique benefits and challenges.
NCT06238089 (www.clinicaltrials.gov).
学习障碍、自闭症或两者兼具的人群停止过度用药(STOMP)项目于2016年启动,以应对对智障人士过度开药的担忧。该项目的重点一直是为个人停用抗精神病药物治疗,而非服务或剂量优化。累积的服务层面抗精神病药物治疗以氯丙嗪单位换算并呈现,这可能有助于比较不同服务机构在抗精神病药物治疗使用方面的情况,并比较不同地区服务机构之间的做法。这项可行性研究的目的是探讨抗精神病治疗负担的累积服务分数是否能够界定英格兰和威尔士不同专业智障服务机构的处方模式,重点关注接受≥2种抗精神病治疗的人群。没有证据表明任何个体需要使用≥2种抗精神病治疗。
该研究是一项可行性横断面研究,在2017 - 2023年的七个年度时间点调查服务机构的抗精神病治疗累积负担。纳入在专业智障服务机构照料下接受≥2种口服和/或长效肌肉注射( depot)抗精神病治疗的成年智障患者的去识别化数据。除了关于所开抗精神病治疗的信息外,还将整理人口统计学和临床数据。将对数据进行完整性评估,并输入统计过程控制工具。将使用多种方法组合来衡量结果,包括描述性分析(包括均值、标准差和百分比值)以及混合效应回归模型,以确定随时间变化的氯丙嗪等效剂量值的变化。
英格兰和威尔士的七个国民健康服务智障服务机构正在招募多达490人。在确定各服务机构中相关的符合条件队列以及实施一套通用的结果测量方面存在公认的挑战。
本研究旨在为设计一个更广泛的登记系统提供决策依据,该登记系统将涉及全国多个地点患者的抗精神病治疗处方数据。利用常规收集的数据开发一个去识别化数据库,无需知情同意,带来了独特的益处和挑战。
NCT06238089(www.clinicaltrials.gov)