Clinical trial NCT01136148: Trial of a Medical and Mental Health Unit for Older People
Official title: 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'.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Confusion
Cognitive Impairment
Delirium
Keywords: Mental Health
Aged
Hospitals, general
Dementia
Delirium
Dementia and confusion
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Nottingham University Hospitals NHS Trust
First posted: 2010-06-03
Enrollment: 600
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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:
* Delirium
* Dementia
* Dementia with a suspicion of super-added delirium

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of days at home in the 3 months after randomisation
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life
timeFrame: 3 months
measure: Behavioural disability
timeFrame: 3 months
measure: Mortality
timeFrame: 3 month
measure: Personal activities of daily living
timeFrame: 3 months
measure: Participant / generic disability
timeFrame: 3 months
measure: Cognition
timeFrame: 3 months
measure: Carer satisfaction with hospital care
timeFrame: 1-3 weeks post discharge from index admission
measure: Carer strain and general health
timeFrame: 3 months
measure: Service Outcomes
timeFrame: 3 months
measure: Quality of care and patient experience on the ward
timeFrame: During hospital stay.
measure: Health and social care costs
timeFrame: 3 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: University of Nottingham
name: John R Gladman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tanajewski L, Franklin M, Gkountouras G, Berdunov V, Harwood RH, Goldberg SE, Bradshaw LE, Gladman JR, Elliott RA. Economic Evaluation of a General Hospital Unit for Older People with Delirium and Dementia (TEAM Randomised Controlled Trial). PLoS One. 2015 Dec 18;10(12):e0140662. doi: 10.1371/journal.pone.0140662. eCollection 2015.
citation: Goldberg SE, Whittamore KH, Pollock K, Harwood RH, Gladman JR. Caring for cognitively impaired older patients in the general hospital: a qualitative analysis of similarities and differences between a specialist Medical and Mental Health Unit and standard care wards. Int J Nurs Stud. 2014 Oct;51(10):1332-43. doi: 10.1016/j.ijnurstu.2014.02.002. Epub 2014 Feb 15.
citation: Goldberg SE, Bradshaw LE, Kearney FC, Russell C, Whittamore KH, Foster PE, Mamza J, Gladman JR, Jones RG, Lewis SA, Porock D, Harwood RH; Medical Crises in Older People Study Group. Care in specialist medical and mental health unit compared with standard care for older people with cognitive impairment admitted to general hospital: randomised controlled trial (NIHR TEAM trial). BMJ. 2013 Jul 2;347:f4132. doi: 10.1136/bmj.f4132.
citation: Harwood RH, Goldberg SE, Whittamore KH, Russell C, Gladman JR, Jones RG, Porock D, Lewis SA, Bradshaw LE, Elliot RA; Medical Crises in Older People Study Group (MCOP). 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': a controlled clinical trial. Acronym: TEAM: Trial of an Elderly Acute care Medical and mental health unit. Trials. 2011 May 13;12:123. doi: 10.1186/1745-6215-12-123.