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临床试验/NCT01136148
NCT01136148已完成不适用

Evaluation of a Medical and Mental Health Unit Compared With Standard Care for Older People Whose Emergency Admission to an Acute General Hospital is Complicated by Concurrent 'Confusion'.

University of Nottingham2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
2
主要终点
Number of days at home in the 3 months after randomisation

研究概览

简要总结

This research is an evaluation of the MMHU compared to standard care. Patients who are over 65 and 'confused' at admission will be randomly allocated to the MMHU or standard care. The MMHU does not have capacity for all confused older patients admitted to NUH, and random allocation is similar to what happens in practice currently. For this study, 480 of these patients will be recruited, together with a carer (240 from the MMHU, 240 from standard care wards). The investigators will collect baseline information about the patient participant's physical and mental health and disability.

The investigators will count the total days spent at home and measure patient participants' health status after 3 months, and use of resources over six months. Carer strain and quality of life will be measured at baseline and follow up.

详细描述

The objectives of this study are:

  1. To evaluate whether a specialist multidisciplinary MMHU for older people with 'confusion', admitted to a general hospital as an emergency, is associated with better outcomes than standard care.
  2. To study the quality of care on the MMHU compared with standard care
  3. To perform a health economic analysis, from the perspective of health and social care.

The principal hypotheses being tested are:

  • That care on the MMHU is associated with more days spent at home (in the 3 months after recruitment) than care on standard wards
  • That care on the MMHU is associated with better health status measured at 3 months, in terms of quality of life, behavioural disturbance, cognitive function, disability, participation, mortality and care home residence.
  • That care on the MMHU is associated with better psychological well being amongst carers and reduced carer strain compared with standard care.
  • That the quality of care and patient experience for patients on the MMHU is superior to that on standard care wards.
  • That care on the MMHU is cost-effective compared with that on standard care wards.

The setting for the study is a large NHS acute teaching hospital organisation with 2 campuses (Queens Medical Centre and City Hospital), comprising 1800 beds, serving a population of 700 000 for general hospital services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 120 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient participants will be over 65, admitted as an emergency to Nottingham University Hospital NHS Trust, with an established or possible physical health problem and concurrent 'confusion', clinically eligible for management on the Medical and Mental Health Unit.
  • Carer participants will be a family member or carer, in regular contact with the patient participant, to serve both as an informant, and, and to study carer health and outcomes.
  • Confusion will be loosely defined, including working diagnoses of:
  • Dementia with a suspicion of super-added delirium

排除标准

  • Those who require sectioning under the Mental Health Act
  • Those with intoxication to illicit drugs or alcohol, or the immediate care of patients with overdose
  • Those with a primary psychiatric problem in the absence of suspected significant physical or functional co-morbidity.
  • Those who are severely medically ill, requiring intensive monitoring or therapy (critical care), or sub-specialist medical intervention (e.g. severe acute GI bleeding, respiratory support).
  • Those with an overriding clinical need for management in another service e.g. stroke, orthogeriatric, renal, oncology.
  • Those with personality disorder, depression or anxiety as the primary psychiatric diagnosis.
  • Those who are registered with a non - Nottingham Primary Care Trust General Practitioner.
  • Those who do not speak English and have no family translator.

结局指标

主要结局

Number of days at home in the 3 months after randomisation

时间窗: 3 months

The primary outcome will be number of days spent at home in the three months following recruitment (or remaining in a care home for those previously resident at recruitment). This encompasses mortality, discharge, length of hospital stay, and ability to sustain discharge and avoid readmission. 'Days at home' will be calculated as 90 days minus the nuimber of days spent dead, in residential intermediate care units, in hospital, in respite care or in a new care home placement at a higher level of dependency.

次要结局

  • Carer satisfaction with hospital care(1-3 weeks post discharge from index admission)
  • Quality of life(3 months)
  • Behavioural disability(3 months)
  • Mortality(3 month)
  • Personal activities of daily living(3 months)
  • Cognition(3 months)
  • Carer strain and general health(3 months)
  • Health and social care costs(3 months)
  • Participant / generic disability(3 months)
  • Service Outcomes(3 months)
  • Quality of care and patient experience on the ward(During hospital stay.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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