Parkinson's Disease: Risk Assessment of Persistent Delirium and Its Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- The duration of delirium will be measured in days.
研究概览
简要总结
Background: delirium describes the change in people's behaviour and thinking when they are unwell. People with delirium may appear confused, have difficulty with organisation and can be different to their usual personality. Older people with Parkinson's are particularly susceptible to persistent delirium, which can last over 14 days. They are more likely to need increased community support and they have a greater risk of death and dementia.
However, there is limited research for people with Parkinson's on how to effectively manage persistent delirium and how to identify those at risk of persistent delirium. Community support may not sufficiently support the care needs of people with Parkinson's, and this is expected to be more detrimental for people also affected by persistent delirium
Study Design: retrospective case note review with qualitative interviews.
Study participants: older people (≥65 years old) with Parkinson's disease, previously affected by either persistent delirium or another form of delirium (e.g. hyperactive, hypoactive, mixed). 207 participants with Parkinson's for quantitative data collection. The qualitative study will include up to 10 participants with Parkinson's from the quantitative part of this study. An additional maximum of 10 more carers for people with Parkinson's may also be interviewed.
Research Aims:
- To develop and estimate the assessment tool's sensitivity and specificity to predict persistent delirium in older people with Parkinson's in the outpatient setting. Persistent delirium in this study will be initially defined as a delirium lasting ≥14 days. An associated secondary objective will be to develop a scoring system that allocates an increasing number of points to risk factors that have a stronger association for predicting delirium.
- To evaluate the management strategies used for persistent delirium.
- To determine what are the community care needs for people recovering from persistent delirium.
详细描述
Background and Rationale Parkinson's disease is the second most common neurodegenerative condition. Delirium is an acute neuropsychiatric syndrome characterised by an altered level of consciousness, confusion and impaired attention. Usually, delirium is transient if the aetiological factors are corrected or if its effects are minimised by medical treatment. Delirium is potentially preventable in 30-40% of cases, but delirium can result in increased mortality and an increased risk of dementia.
Persistent delirium is when delirium continues to affect patients over weeks to months. However, the exact duration for delirium to be defined as being persistent remains controversial. Previous studies have reported the duration of persistent delirium to be between 7 days to >4 weeks. Persistent delirium in this study will be defined as delirium lasting ≥14 days, which is the average reported by the previous studies. Delirium in older people at the point of hospital discharge is associated with worse outcomes regarding function, cognition, mortality and are more likely to need nursing home placement.
People with Parkinson's could be five times more likely to develop delirium and often delirium in Parkinson's is under-recognised in secondary care.
The use of risk stratification of delirium in people with Parkinson's could highlight the most vulnerable patients so that preventive care can be implemented to minimise their risk of adverse outcomes and complications.
Currently, management strategies for delirium in Parkinson's disease are predominantly based on expert opinion and there is a need for research to determine what are the optimal management strategies for this patient group. Moreover, there are concerns that current community support services do not adequately address the psychosocial issues in older people with advanced Parkinson's disease, which may provide an even greater challenge for patients recovering from persistent delirium.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for People with Parkinson's:
- •Participants must be aged at least 65 years old in
- •Participants must have a diagnosis of idiopathic Parkinson's disease using Queen's Square Brain Bank criteria (32) diagnosed by a movement disorders expert.
- •Admitted patients must have stayed in hospital >24 hours for at least one hospital admission.
- •Participants must have had previous admissions/attendance to the hospital between 2015-
- •An appropriate consultee must be available and willing to be involved in this study for potential participants without the mental capacity to consent to the extraction of information from their medical records.
- •For the qualitative study, participants must have the mental capacity to consent and must have been affected by persistent delirium. The participant must be able to understand, write and speak English.
- •Inclusion Criteria for Carers in the Qualitative Study
- •Participants must be aged 18 or over.
- •Participants must have the mental capacity to consent.
- •Participants must have been a primary carer for someone living with Parkinson's, who has had a previous experience of persistent delirium, during 2015-
- •Participants must be able to understand, write and speak English.
排除标准
- •Exclusion Criteria for People with Parkinson's
- •Aged less than 65 years old in
- •Diagnosed with drug-induced parkinsonism, vascular parkinsonism, atypical Parkinsonian disorder (e.g. progressive supranuclear palsy, multiple systems atrophy, corticobasal syndrome) or dementia (e.g. dementia with Lewy bodies, vascular dementia, Alzheimer's disease).
- •Potential participants will be excluded from the interview if they cannot communicate verbally or cannot read/write in English.
- •The potential participant's medical records are incomplete and no alternate strategies are appropriate to account for the missing data, without introducing significant study bias or inaccuracy in statistical findings. Criteria for when the medical records will be excluded in the analysis will be:
- •There is uncertainty regarding the identity of the medical records.
- •Documentation for the admission of interest is missing to the extent that researchers are unable to extract the relevant data required for the aims of this study.
- •For the qualitative study, potential participants will be excluded if they do not have the mental capacity to consent.
- •Potential participants without a consultee and also do not have the mental capacity to consent to this study.
- •Potential deceased participants will be excluded if there is previous documentation that the person would not have wanted to participate in research studies.
- •Exclusion Criteria for Carers in the Qualitative Study
- •The potential participant is aged less than 18 years old.
- •The potential participant does not have the mental capacity to consent to this study.
- •The potential participant is not the primary carer for someone with Parkinson's and has been affected by persistent delirium, during 2015-
- •The potential participant does not understand, write and/or speak English.
- •The potential participant has a severe speech impairment to the extent that the audio recording of the interview is unintelligible.
结局指标
主要结局
The duration of delirium will be measured in days.
时间窗: Time frame: measured when the participant has previously encountered healthcare professionals during 2015-2019.
Once delirium is confirmed by the DSM-V criteria, then the number of days that participants are affected by delirium will be inferred from medical notes.
The incidence and prevalence of delirium in older people with Parkinson's, measured by the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorders 5th edition).
时间窗: Time frame: measured when the participant has previously encountered healthcare professionals during 2015-2019.
DSM-V (Diagnostic and Statistical Manual of Mental Disorders 5th edition) will be used to confirm the diagnosis of delirium.
次要结局
未报告次要终点