Trial of a Medical and Mental Health Unit for Older People
Condition: Dementia; Confusion; Cognitive Impairment; Delirium
MeSH terms: Dementia; Delirium; Confusion
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Sample size is determined by available resources. 240 patients randomised to the MMHU unit
      over 24 months, and an equal number of controls, should be sufficient to measure, with 80%
      power, a 3 to 6-day reduction in length of stay, and 15% increase in the proportion of
      participants discharged home (e.g. 50% to 65%). Power will be greater for scaled outcomes,
      and the 'days at home' outcome.

      The main study will run for up to 24 months from July 2010. Follow up will be 3 months after
      randomisation.

      Prior to trial commencement we will run 1 or 2 short pilot studies, during which we will test
      the recruitment and ward allocation processes.

      The study is designed to be robust, despite being constrained by the operational needs of the
      clinical service, and both service and research capacity.

      The NHS Trust clinical service has agreed that, for the duration of the study, allocation to
      the MMHU will be by randomisation. This is not part of the research, but represents clinical
      service support for it. Potential participants will be identified by the Acute Medical Unit,
      on simple criteria (''confused', over 65'). The MMHU will confirm clinical eligibility and
      complete a screening log. If there is a bed available on MMHU the patient will be randomised
      using an internet based randomisation system (with stratification on care home residence),
      and the patient assigned to MMHU or a standard care ward. Non-randomised patients can be
      referred, and, if appropriate, randomised, later in their hospital stay.

      Research eligible patients and carers will be invited to participate in research, once on
      their allocated ward. Consent and participation will be for data collection, observation of
      care, and follow up only. Excluded patients will continue on their allocated ward outside the
      trial.
    

Intervention name(s): A medical and mental health unit
Intervention type(s): Behavioral
Intervention description(s): A specialist medical and mental health unit with both physician and psychiatric medical and nursing staff, and mental health experienced therapists. Emphasis will be on early and accurate diagnosis, multidisciplinary management, rigorous communication and goal setting, discharge planning and interface with community services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Mental Health; Aged; Hospitals, general; Dementia; Delirium; Dementia and confusion