Trial of a Medical and Mental Health Unit for Older People

NCT01136148 | Completed

• 2 other identifiers: 10004RP-PG-0407-10147
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Confusion; Cognitive Impairment; Delirium

Keywords

Mental Health; Aged; Hospitals, general; Dementia; Delirium; Dementia and confusion

Outcome Measures

Primary Outcomes (1)

• Number of days at home in the 3 months after randomisation

  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.

  3 months

Secondary Outcomes (11)

• Quality of life

  3 months

• Behavioural disability

  3 months

• Mortality

  3 month

• Personal activities of daily living

  3 months

• Participant / generic disability

  3 months

Study Arms (2)

A Medical and Mental Health Unit

EXPERIMENTAL

A specialist unit for cognitively impaired older patients admitted as a medical emergency to the acute hospital.

Behavioral: A medical and mental health unit

Standard care wards

ACTIVE COMPARATOR

The standard care provided by the acute hospital for cognitively impaired older patients admitted as a medical emergency.

Behavioral: A medical and mental health unit

Interventions

A medical and mental health unit BEHAVIORAL

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.

A Medical and Mental Health Unit; Standard care wards

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• National Institute for Health Research, United Kingdom: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 26684872 DERIVED

• 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.

  PMID: 24613652 DERIVED

• 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.

  PMID: 23819964 DERIVED

• 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.

  PMID: 21569471 DERIVED

MeSH Terms

Conditions

Dementia; Confusion; Cognitive Dysfunction; Delirium; Psychological Well-Being

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Personal Satisfaction; Behavior

Study Officials

• John R Gladman

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

GB (1)