DementiaTEAMNCT01136148
Trial of a Medical and Mental Health Unit for Older People
A study testing A medical and mental health unit in people with Dementia and Confusion, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Dementia, Confusion, Cognitive Impairment
- What is being tested?
- A medical and mental health unit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottingham, NG7 2UH
About this study
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'.
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.
Read the detailed description
The objectives of this study are:
- 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.
- To study the quality of care on the MMHU compared with standard care
- 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.
- Conditions
- Dementia, Confusion, Cognitive Impairment, Delirium
- Being tested
- A medical and mental health unit
- Keywords
- Mental Health, Aged, Hospitals, general, Dementia, Delirium, Dementia and confusion
- Medical subject headings
- Dementia, Confusion, Cognitive Dysfunction, Delirium, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A medical and mental health unitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A Medical and Mental Health Unit | Experimental | A specialist unit for cognitively impaired older patients admitted as a medical emergency to the acute hospital. Receives: 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. Receives: Behavioral: A medical and mental health unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (11)
Quality of life
Dementia quality of life (Demqol, patient and proxy) and generic quality of life (Euroqol EQ5D).
Measured: 3 months
Behavioural disability
Neuropsychiatric inventory.
Measured: 3 months
Mortality
Measured: 3 month
Personal activities of daily living
Barthel ADL Index
Measured: 3 months
Participant / generic disability
short London Handicap Scale
Measured: 3 months
Cognition
MMSE, in particular to detect recovery of delirium
Measured: 3 months
Carer satisfaction with hospital care
Satisfaction with care received questionnaire
Measured: 1-3 weeks post discharge from index admission
Carer strain and general health
Carer strain index and carer general health questionnaire GHQ-12.
Measured: 3 months
Service Outcomes
Days in each type of ward. Hospital re-admissions, and total hospital length of stay. New institutionalisation (or moving to a higher level of dependency for those in a care home) Days in a care home (including respite care) GP visits, and use of other primary care contacts (district nurse, community matron, practice nurse) Hospital appointments Attendances at physical and mental health day hospitals Contact with community mental health teams (including community psychiatric nursing) Use of ambulance service Use of social service home care and day centres.
Measured: 3 months
Quality of care and patient experience on the ward
Quality of care and patient experience will be measured using Dementia Care Mapping on both the MMHU and standard care. Dementia Care Mapping provides a structured record of activity levels, mood and engagement of participants and the quality of staff interactions over a 4-6 hour period.
Measured: During hospital stay.
Health and social care costs
Service outcomes will be costed using specific costs where available or standard reference costs otherwise.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- John R Gladman, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136148
- Sponsor's protocol ID
- 10004
- Other IDs
- RP-PG-0407-10147
- Acronym
- TEAM
- Status last verified
- Dec 2015
- First submitted
- 2 Jun 2010
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26684872Goldberg 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.
PubMed 24613652Goldberg 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.
PubMed 23819964Harwood 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.
PubMed 21569471
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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'.
- ClinicalTrials.gov ID
- NCT01136148
- Acronym / sponsor ID
- TEAM / 10004
- Conditions
- Dementia, Confusion, Cognitive Impairment, Delirium
- Keywords
- Mental Health, Aged, Hospitals, general, Dementia, Delirium, Dementia and confusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Nottingham University Hospitals NHS Trust
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To study the quality of care on the MMHU compared with standard care
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Medical and Mental Health Unit | Experimental | Behavioral: A medical and mental health unitA specialist unit for cognitively impaired older patients admitted as a medical emergency to the acute hospital. |
| Standard care wards | Active comparator | Behavioral: A medical and mental health unitThe standard care provided by the acute hospital for cognitively impaired older patients admitted as a medical emergency. |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A medical and mental health unitA 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. | Behavioural | A Medical and Mental Health Unit, Standard care wards |
Primary outcome
Number of days at home in the 3 months after randomisation
Time frame: 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.
11 secondary outcomes
Quality of life
Time frame: 3 months
Behavioural disability
Time frame: 3 months
Mortality
Time frame: 3 month
Personal activities of daily living
Time frame: 3 months
Participant / generic disability
Time frame: 3 months
Cognition
Time frame: 3 months
Carer satisfaction with hospital care
Time frame: 1-3 weeks post discharge from index admission
Carer strain and general health
Time frame: 3 months
Service Outcomes
Time frame: 3 months
Quality of care and patient experience on the ward
Time frame: During hospital stay.
Health and social care costs
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Derived from this study: PubMed 26684872Tanajewski 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.
- Derived from this study: PubMed 24613652Goldberg 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.
- Derived from this study: PubMed 23819964Goldberg 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.
- Derived from this study: PubMed 21569471Harwood 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Gladman principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A medical and mental health unit in people with Dementia and Confusion, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days at home in the 3 months after randomisation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01136148, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.