A feasibility study of an implementation strategy to improve the detection, assessment, management and prevention of delirium in hospices
| ISRCTN | ISRCTN55416525 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55416525 |
| IRAS number | 299277 |
| Secondary identifying numbers | IRAS 299277 |
- Submission date
- 22/06/2021
- Registration date
- 30/06/2021
- Last edited
- 30/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
It is common for people to suffer from acute confusion (delirium) towards the end of their life. People with delirium may see or hear things that aren’t there and say or do things that are out of character. This is distressing for them, their family, carers and friends. It’s important to improve how we assess, prevent, and manage delirium in hospices.
Guidelines for improving delirium care have been issued by, amongst others, the National Institute for Health & Care Excellence. These guidelines clearly state the role of doctors, nurses, and other staff in assessing (using validated questions), preventing (by enabling daily activities of living and symptom management), and managing delirium (by minimising distress). However, in a national UK survey, 38% of palliative care physicians never used delirium guidelines and only 10% of hospices used a delirium screening tool.
The aim of this study is to underpin a future study that tests whether the use of an implementation strategy (the intervention) designed to improve guideline-adherent delirium care in palliative care settings is associated with improved patient outcomes (reduced number of days with delirium).
Who can participate?
Members of the public and hospice volunteers, staff, and management.
What does this study involve?
This study addresses the guideline implementation challenge of how to bring together practical support (e.g. screening tools and clinical pathways) and communication between family, friends, volunteers, and health professionals to support hospice teams to deliver guideline-adherent delirium care in everyday practice. At three Yorkshire hospices, the researchers will:
1. Run workshops with members of the public and hospice volunteers, staff, and management to adapt an existing implementation plan for hospices
2. Test the potential for a future national study to see if better implemented guideline-adherent care benefits patients (reduces delirium) by studying the feasibility of using clinical record entries to diagnose delirium, study participation, and the extent to which the implementation plan was used
3. Assess the acceptability and flexibility of the implementation plan in hospice volunteers, staff, and management using surveys and interviews about their experiences of implementing delirium guidelines
What are the possible benefits and risks of participating?
This research will address the Department of Health and Social Care's recommendation of ensuring equal access to high-quality palliative care through symptom assessment, management, and prevention, and the NHS Long Term Plan priority area of providing 'out of hospital' care within Integrated Care Systems. The researchers do not anticipate any risk in this study to staff, patients, or carers.
Where is the study run from?
University of Hull (UK)
When is the study starting and how long is it expected to run for?
February 2021 to February 2023
Who is funding the study?
Yorkshire Cancer Research (UK)
Who is the main contact?
Dr Mark Pearson
Mark.pearson@hyms.ac.uk
Contact information
Scientific
Wolfson Palliative Care Research Centre
Hull York Medical School
Allam Medical Building
University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom
| Phone | +44 (0)1482 463442 |
|---|---|
| miriam.johnson@hyms.ac.uk |
Scientific
Wolfson Palliative Care Research Centre
Hull York Medical School
Allam Medical Building
University of Hull
Cottingham Road
Hull
Hu6 7RX
United Kingdom
| Phone | +44 (0)1482 463335 |
|---|---|
| mark.pearson@hyms.ac.uk |
Public
Wolfson Palliative Care Research Centre
Hull York Medical School
Allam Medical Building
University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom
| Phone | +44 (0)7711387831 |
|---|---|
| gillian.jackson@hyms.ac.uk |
Study information
| Study design | Multi-centre co-design and feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Feasibility study and process evaluation |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | ISRCTN55416525_PIS_V1.0.pdf |
| Scientific title | The DAMPen-D study - improving the Detection, Assessment, Management, and Prevention of Delirium in hospices: co-design and feasibility study of a flexible and scalable implementation strategy to deliver guideline-adherent delirium care |
| Study acronym | DAMPen-D |
| Study hypothesis | To underpin a future national quasi-experimental study that tests whether the use of an implementation strategy (the intervention) designed to improve guideline-adherent delirium care in palliative care settings is associated with improved patient outcomes (reduced number of days with delirium), this study will demonstrate if it is possible to: 1. Co-adapt an implementation strategy (Creating Learning Environments for Compassionate Care (CLECC)) for use in hospices (Work Package 1) 2. Systematically and reliably collect data (including delirium diagnosis) from clinical records in a way that minimises burden for patients, families, and staff (Work Package 2) 3. Collect measures of staff engagement with the implementation strategy, delivery of guideline-adherent delirium care, and the costs of staff involvement (Work Packages 2 and 3) 4. Collect explanatory process data about staff use of the implementation strategy (Work Package 3) 5. Estimate the number of palliative care sites and in-patient episodes needed for the planned national quasi-experimental study |
| Ethics approval(s) | 1. Approved 15/04/2021, Hull York Medical School Ethics Committee (University of Hull, Cottingham Road, Hull HU6 7RX, UK; +44 (0)870 1245500; info@hyms.ac.uk), ref: 21/23 2. Approved 28/05/2021, Health Research Authority (HRA) Research Ethics Committee, Wales REC 7 (Public Health Wales Meeting Room, Building 1, St. David’s Park, Carmarthen, SA31 3HB, UK; +44 (0)29 2023 0457; Wales.REC7@wales.nhs.uk), ref: 21/WA/0180 3. Approved 14/06/2021, Health Research Authority (HRA) Confidentiality Advisory Group (CAG) (2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)20 7104 8100, cag@hra.nhs.uk), ref: 21/CAG/0070 |
| Condition | Detection, assessment, management and prevention of delirium in hospice in-patients |
| Intervention | Each hospice will be supported by the study team to use the CLECC-Pal plan to implement guideline-adherent delirium care over a minimum 12-week period. Hospices who wish to continue following this period (e.g. if they find it helpful) would be encouraged to do so. A hospice lead clinician has been identified and the following CLECC-Pal activities will be put in place (NB these may be subject to change depending on Work Package 1: co-design workshops) 1. A team study session in which CLECC-Pal is introduced and training given regarding guideline-adherent delirium care, including use of screening tools, patient care plans and computer- or paper-based templates for clinical record keeping (as relevant). Teaching materials and IT templates for SystOne are already prepared during our previous work 2. Ward manager action learning sets, mid-shift ‘cluster discussions’ and twice-weekly reflective discussions regarding the use of guideline-adherent delirium care, and peer observations of practice |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility will be assessed by: 1. Number of relevant hospice staff engaging and maintaining engagement with CLECC-Pal during the 12-week intervention period 2. Ability to collect high validity, anonymised delirium outcome data from clinical records using an expanded version of a chart based tool developed by Inouye et al. at baseline and 12 weeks 3. Cost data in relation to the number of staff hours engaged in CLECC-Pal activities during the 12-week intervention period 4. Variability in delirium day measures (to calculate sample size for a subsequent national study) at baseline and at 12 weeks |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 15/02/2021 |
| Overall study end date | 14/02/2023 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Work package 1: Not applicable; Work package 2: 300 case records; Work package 3: 30 survey responses, 15 interviews |
| Total final enrolment | 425 |
| Participant inclusion criteria | Work package 1 (co-design): Not applicable Work package 2 (feasibility study): In-patients admitted to study hospices Work package 3 (process evaluation): Hospice staff (healthcare assistants, nurses, allied health professionals, doctors, volunteers, care managers and executive board members) and volunteers directly and/or indirectly involved with the delivery of care |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 05/07/2021 |
| Recruitment end date | 31/01/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Hull
HU8 8DH
United Kingdom
York
YO24 1GL
United Kingdom
Bradford
BD3 9LE
United Kingdom
Scarborough
YO12 5RE
United Kingdom
Sponsor information
University/education
Cottingham Road
Hull
HU6 7RX
England
United Kingdom
| Phone | +44 (0)1482 466732 |
|---|---|
| david.richards@hull.ac.uk | |
| Website | http://www.hull.ac.uk |
"ROR" |
https://ror.org/04nkhwh30 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- YCR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 15/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | A full report of the study’s methods and findings will be prepared for the funder (Yorkshire Cancer Research) and a manuscript reporting the findings submitted to a peer-reviewed journal. The study’s findings will be submitted for oral presentation at one national health services research conference and one international palliative care conference. A plain English summary of study findings will be prepared for distribution through palliative care clinical networks (including Hospice UK) and public involvement groups. Consistent with our application to Health Research Authority Confidentiality Advisory Group, participant-level data will not be shared. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. Whilst the data is completely anonymous and would be suitable for sharing, following discussion with Patient & Public Involvement Group members who expressed some concern, the researchers felt it was more appropriate to uphold their wishes to not share the data. The data will be preserved for 5 years after the research has taken place in the Hull Health Trials Unit Box (a cloud-based storage system that uses AES-256 encryption in transit and at rest). Once the 5 years is complete, the data will be destroyed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.0 | 08/07/2021 | No | Yes | |
| Protocol article | 13/07/2022 | 14/07/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/04/2024 | 30/09/2024 | Yes | No |
Additional files
- ISRCTN55416525_PIS_V1.0.pdf
- Uploaded 08/07/2021
Editorial Notes
30/09/2024: Publication reference added.
11/08/2023: The intention to publish date has been changed from 12/08/2023 to 15/02/2024.
06/03/2023: Total final enrolment.
14/07/2022: Publication reference added.
14/03/2022: The following changes were made to the trial record:
1. The overall end date was changed from 12/08/2022 to 14/02/2023.
2. The recruitment end date was changed from 31/05/2022 to 31/01/2023.
3. The trial participating centre St Catherine's Hospice was added
4. The plain English summary was updated to reflect these changes.
08/07/2021: The participant information sheet has been uploaded.
28/06/2021: Trial's existence confirmed by Health Research Authority (HRA) Research Ethics Committee, Wales REC 7.
