Achieving quality and effectiveness in dementia using crisis teams
| ISRCTN | ISRCTN42855694 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42855694 |
| IRAS number | 289982 |
| Secondary identifying numbers | IRAS 289982, CPMS 48057 |
- Submission date
- 05/11/2020
- Registration date
- 04/03/2021
- Last edited
- 14/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study is called the ‘Achieving Quality and Effectiveness in Dementia Using Crisis Teams’ or AQUEDUCT study. Previous research undertaken as part of the AQUEDUCT programme found that Teams Managing Crisis in Dementia (TMCD) vary greatly in terms of team names, eligibility criteria, staffing, duration of contact with the person with dementia, and interventions available. The AQUEDUCT research programme aims to provide a best practice model against which TMCDs can evaluate their provision of crisis care for people with dementia; teams can then use the online Resource Kit to strengthen their provision of care. The aim of the AQUEDUCT study is to investigate the use of an online resource kit by clinical practitioners working in community TMCDs in the NHS in England.
Who can participate?
This study involves TMCDs managing mental health crises in dementia in community settings, and practitioners, people with dementia and carers associated with these TMCDs. People with dementia and carers can only take part in the study if they have received clinical input from a TMCD because of a mental health crisis.
What does the study involve?
TMCDs will be randomly allocated to one of two groups. Practitioners in the intervention group (15 TMCDs) will receive training in the use of an online password-protected resource kit and will use it with all instances of dementia crisis screened into their service over a 6-month period. The Resource Kit has two elements: a 'best practice tool' that TMCDs can use to evaluate their practice, and a collection of templates and documents (which can be downloaded by the team) to help practitioners improve their practice. TMCDs (15 TMCDs) in the control group will not have access to the resource kit and will conduct treatment as usual (TAU) for the same period. The study will look at how the Resource Kit is used in practice and the impact it has, particularly on related costs such as hospital admissions. The findings from this study will help the research team to evaluate how useful the Resource Kit has been and whether it helps to improve the practice of clinical staff in TMCDs.
What are the possible benefits and risks of participating?
There will be no immediate benefits to participants for taking part in this study; however, they may be introduced to some new ideas about best practice for crisis teams which manage dementia. The research team cannot promise that the study will help participants directly, but the information obtained from this study may help to improve the work of crisis teams in the future. If a person with dementia, carer or TMCD staff member chooses to take part, they will be contributing to a National Institute for Health Research (NIHR) study that could have an impact on how TMCDs across England will operate. The research team considers there to be minimal disadvantages to participating in this study.
Where is the study run from?
Institute of Mental Health at the University of Nottingham (UK)
When is the study starting and how long is it expected to run for?
January 2019 to November 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Martin Orrell, m.orrell@nottingham.ac.uk
Dr Linda Oraw, Linda.Oraw@nottingham.ac.uk
Contact information
Scientific
Institute of Mental Health
University Of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom
 ORCID ID |
0000-0002-1169-3530 |
|---|---|
| Phone | +44 (0)115 748 4309 (administrator) |
| m.orrell@nottingham.ac.uk |
Public
Institute of Mental Health
University Of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom
| ORCID ID |
0000-0001-5265-2885 |
|---|---|
| Phone | +44 (0)7791598280 |
| linda.oraw@nottingham.ac.uk |
Study information
| Study design | Pre-post group-comparison multicentre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Achieving quality and effectiveness in dementia using crisis teams (AQUEDUCT): a randomized controlled trial of a resource kit for teams managing crisis in dementia |
| Study acronym | AQUEDUCT Main Trial |
| Study objectives | The 'Achieving Quality and Effectiveness in Dementia' (AQUEDUCT) research programme aims to improve care for people with dementia experiencing a mental health crisis. This randomized controlled trial (RCT) will investigate use of an online Resource Kit by clinical Teams Managing Crisis in Dementia (TMCDs) on hospital admissions and costs, as well as the experience for people with dementia and carers receiving input. |
| Ethics approval(s) | Approved 09/03/2021, HRA and Health and Care Research Wales (HCRW) Approval (Psychiatry and Applied Psychology, Faculty of Medicine & Health Sciences University of Nottingham Institute of Mental Health University of Nottingham Innovation Park Triumph Road, Nottingham, NG7 2TU, United Kingdom; +44 (0)7791598280; linda.oraw@nottingham.ac.uk), ref: REC 21/WM/0004 |
| Health condition(s) or problem(s) studied | People with dementia experiencing a mental health crisis and carers receiving clinical input from a dementia crisis team (Team Managing Crisis in Dementia - TMCD) |
| Intervention | This pre-post group-comparison multi-centre RCT will be carried out with 30 dementia crisis teams (TMCDs) across England. Once consent has been obtained from each Team Managing Crisis in Dementia (TMCD), the TMCD will be entered onto a web-based randomisation system and be randomly assigned to one of two arms, either RK (using the Resource Kit) or TAU (treatment as usual) with equal opportunity. The allocation will be determined by a computer-generated pseudo-random code using random permuted blocks of varying size, stratified by the population size (number of people with dementia) in each TMCD catchment area. The block size will not be disclosed. Patients, carers, outcome assessors and statisticians will be blinded to TMCD arm allocation until the data analysis is completed. Practitioners in the intervention arm (15 TMCDs) will receive training in the use of an online password-protected Resource Kit and will use it with all instances of dementia crisis screened into their service over a 6-month period. The Resource Kit has two elements: a 'Best Practice Tool' that TMCDs can use to evaluate their practice, and a collection of templates and documents (which can be downloaded by the team) to help practitioners improve their practice. TMCDs (15 TMCDs) in the control arm will not have access to the Resource Kit and will conduct Treatment as Usual (TAU) for the same period. |
| Intervention type | Other |
| Primary outcome measure | Number of mental health hospital admissions measured using hospital admissions records for people with dementia in the geographical catchment area covered by the TMCD (as defined by postcode) at baseline and 6 months |
| Secondary outcome measures | 1. Number of acute/general hospital admissions measured using hospital admissions records for people with dementia in the geographical catchment area covered by the TMCD (as defined by postcode) at baseline and 6 months 2. Client satisfaction measured for people with dementia and carers using the Client Satisfaction Questionnaire (CSQ-8) once post discharge from the TMCD 3. Quality of life measured for people with dementia and carers using the Quality of Life Questionnaire (EQ-5D-5L) once post discharge from the TMCD 4. General health measured for people with dementia and carers using the General Health Questionnaire (GHQ-12) once post discharge from the TMCD 5. Work acceptance and action measured for TMCD practitioners using the Work Acceptance & Action Questionnaire (WAAQ) at baseline and 6 months 6. Work engagement measured for TMCD practitioners using the Work Engagement Scale (Utrecht – UWES) at baseline and 6 months 7. General health measured for TMCD practitioners using the General Health Questionnaire (GHQ-12) at baseline and 6 months 8. Staff sickness levels measured for TMCD practitioners using TMCD staff sickness records at baseline and 6 months |
| Overall study start date | 01/01/2019 |
| Completion date | 30/11/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 384 |
| Key inclusion criteria | Teams (TMCDs) managing mental health crises in dementia in community settings, and practitioners, people with dementia and carers associated with these TMCDs. No age range criteria are set for any participants. |
| Key exclusion criteria | Teams (TMCDs) will be excluded for the following reasons: 1. Team is not defined by service/NHS Trust as having a role in dementia mental health crisis management 2. Team does not meet the following definition for mental health crisis: providing urgent mental health assessment and intervention for people with dementia in the community 3. A major service reorganisation is planned over the study period, or is anticipated in the near future 4. NHS Trust and team are not able to demonstrate capacity and capability to complete required research activities 5. Team is co-located with another team taking part in this study; sharing the same site is acceptable but sharing the same office is not 6. Team shares immediate management structures with another team taking part in this study; sharing a management structure above the level of team leader is acceptable but sharing a team leader is not 7. Core clinical staff for team do not operate separately from another team taking part in this study; this includes a requirement that core clinical staff must not engage in clinical cross cover with another team taking part in this study 8. Team shares core administrative staff with another team taking part in this study 9. If a team leader who has been exposed to the intervention becomes lead for a team in the control arm of the RCT, that latter team will then be excluded |
| Date of first enrolment | 01/01/2021 |
| Date of final enrolment | 01/09/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Porchester Road
Nottingham
NG3 6AA
United Kingdom
Dryden Road
Exeter
EX2 5AF
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Mark Howells
Head of Research and Evidence
Duncan MacMillan House
Porchester Road
Mapperley
Nottingham
NG3 6AA
England
United Kingdom
| Phone | +44 (0)1159691300 |
|---|---|
| Mark.Howells@nottshc.nhs.uk | |
| Website | http://www.nottinghamshirehealthcare.nhs.uk/ |
"ROR" |
https://ror.org/04ehjk122 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Both the study protocol and statistical analysis plan are available. The researchers intend to publish the study protocol in a peer-reviewed journal before the study end date (November 2022). They intend to publish study outcomes 1 year after the study end date (i.e by November 2023). The AQUEDUCT research team will identify a variety of channels for dissemination to patient and public involvement (PPI) representatives, research sites, and other key stakeholders. Findings will be relevant to healthcare professionals working with older people in settings where people with dementia and carers are likely to request support leading up to or during a mental health crisis. This work may prove useful for service commissioners, other health and social care professionals, and researchers both nationally and internationally. Results from this study will be written up for suitable peer-reviewed journals and presented at relevant conferences and events. The Resource Kit will not be made available for widespread dissemination until the trial has ended, in order to avoid contamination of sites seeking to participate; however, once the trial is completed, a programme of implementation and long-term dissemination of the online Resource Kit will begin. Participants can request a copy of results from the Chief Investigator; this information will only be provided after the final study report has been completed. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 08/11/2020 | 04/03/2021 | No | No | |
| Statistical Analysis Plan | version v20 | 04/03/2021 | No | No | |
| Protocol article | 18/01/2022 | 20/01/2022 | Yes | No | |
| Protocol file | version 10 | 01/10/2022 | 23/11/2022 | No | No |
| Results article | 11/07/2025 | 14/07/2025 | Yes | No |
Additional files
- ISRCTN42855694_PROTOCOL_V8_Nov2020.pdf
- Uploaded 04/03/2021
- ISRCTN42855694_SAP_Nov20.pdf
- Uploaded 04/03/2021
- 39011 AQUEDUCT MainTrial Protocol v10 01Oct2022.pdf
Editorial Notes
14/07/2025: Publication reference added.
07/11/2024: Ethics approval details added.
07/09/2023: The study scientific contact confirmed that all study dates were accurate at that time.
06/02/2023: The recruitment end date was changed from 01/02/2023 to 01/09/2023.
23/11/2022: The following changes were made to the trial record:
1. The protocol v10 was uploaded as an additional file.
2. The public contact was changed.
3. The overall end date was changed from 14/08/2023 to 30/11/2023.
4. The target number of participants was changed from 687 to 384.
5. The plain English summary was updated to reflect these changes.
08/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2022 to 01/02/2023.
2. The overall trial end date was changed from 30/11/2022 to 14/08/2023.
3. The intention to publish date was changed from 30/11/2023 to 30/11/2024.
20/01/2022: Publication reference added.
04/03/2021: Uploaded protocol version 8, November 2020 (not peer reviewed). Uploaded statistical analysis plan.
12/11/2020: Trial's existence confirmed by University of Exeter.
