Optimising palliative care for older people in community settings
| ISRCTN | ISRCTN45837097 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45837097 |
| Protocol serial number | Phase 1b and 2: UKCRN ID - 15880; Phase 1a: UKCRN ID: 13275 |
| Sponsor | King's College London (UK) |
| Funder | National Institute for Health Research |
- Submission date
- 16/01/2014
- Registration date
- 16/01/2014
- Last edited
- 21/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
People are living longer and more often die following a period of increasing illness and difficulties with their health. Palliative care is recommended for elderly people living with frailty and non-cancerous conditions to improve their quality of life and that of their carers, but how to achieve this is still uncertain. Palliative care is active holistic care that aims to relieve and avoid suffering for patients and their families, addressing physical, emotional, social and spiritual needs. Palliative care, unlike end of life or hospice care, is relevant at all stages of illness, including during curative treatment as well as at the end of life. This study aims to work with an NHS Community Trust to create and test a new service for frail elderly people with non-cancerous conditions living at home or in a care home. The new service is delivered by close working between specialists in palliative care such as Macmillan Nurses, and services provided by community workers such as community nurses and general practitioners (GPs).
Who can participate?
People aged 75 years or older and their carers can participate in this study.
What does the study involve?
The study has two parts:
Part one uses information gathered from a postal survey sent to 882 bereaved relatives or carers of people aged over 75 years to find out how health services could be better provided to support older people living with frailty and when nearing the end of life. We then ask older people and carers, professionals providing health and social care, and members of voluntary groups about what people told us in the survey and the best ways to create the new service. This takes place in group discussions in January and February 2014.
Part two looks at what is the best way to provide the proposed service and how the new service could benefit patients and carers. We ask 52 older people living with frailty and increasing health difficulties, and their carers, to receive either the new palliative care service or usual care provided by people like their GP. The new service is delivered by two palliative care teams working with four community nursing teams in a single Community NHS Trust. The new service involves up to three visits in the community by the specialist palliative care teams to provide an extra layer of support for frail older people and their carers at times of deterioration. Participants who receive usual care in the study are offered the new service at the studys completion. We will see how well the new service compares with usual care in improving symptom burden, carers support and any differences in the services used and how much they cost. This will tell us if this new service could benefit patients and carers.
What are the possible benefits and risks of participating?
This study will help to inform how we should continue our work to see if this is the best way to deliver palliative care to older people in the community. There are minimal risks to participating as the study is extending an existing service to a new population group.
Where is the study run from?
The study is run from Sussex Community NHS Foundation Trust and takes place in four GP practices (UK)
When is the study starting and how long is it expected to run for?
The study started in January 2014. Part 2 will run from May 2014 until May 2016.
Who is funding the study?
The National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Catherine Evans
catherine.evans@kcl.ac.uk
Tel: +44 (0)207 848 5579
Contact information
Scientific
Cicely Saunders Institute
Bessemer Road
Denmark Hill
London
SE5 9PJ
United Kingdom
 ORCID ID |
0000-0003-0034-7402 |
|---|---|
| Phone | +44 207 848 5579 |
| catherine.evans@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional and Observational; Design type: Treatment, Qualitative |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Optimising palliative care for older people in community settings: development and evaluation of a new short term integrated service (phases 1b and 2) |
| Study acronym | OPTCare Elderly |
| Study objectives | Palliative care is advocated for frail older people with non-malignant conditions to improve assessment and treatment, but with little evidence of effectiveness. Short-term palliative care could be effective as it relies on existing services with additional support at times of actual or anticipated deterioration in wellbeing. This study intends to work with NHS staff in a community trust to develop a new short-term integrated palliative and supportive care (SIPS) service for frail older people living at home or in a care home and for their families. The new service will be evaluated in a community setting to test the impact on palliative symptoms, carer burden, formal and informal service use and to evaluate the cost. |
| Ethics approval(s) | London - Queen Square Research Ethics Committee, 17/10/2013, ref: 13/LO/1304 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England, Generic Health Relevance and Cross Cutting Themes; Subtopic: Not Assigned, Generic Health Relevance (all Subtopics); Disease: All Diseases, Age and ageing |
| Intervention | Interventions as of 09/11/2016: Participants are randomly allocated to intervention or control group following consent. Intervention arm: This involves a service delivered by two palliative care teams working with four community nursing teams in a single Community NHS Trust. The new service involves up to three visits in the community by the specialist palliative care teams to provide an extra layer of support over a 12 week period. Control arm: Participants receive their usual care provided by their GP or community nursing team. After 12 weeks, this group are offered the intervention however there is no research follow-up for this group beyond the 12 weeks from consent. Both groups are given questionnaires to complete at baseline, 6 weeks and 12 weeks and the GP records are followed up for 6 months. The intervention group are also invited to take part in a qualitative interview after the 12 week study period. Original interventions section: SIPC: SIPC - short term integrated palliative. The SIPC intervention intends to provide an extra layer of support at points of actual or anticipated unstable/ deteriorating symptom presentation and wellbeing. The SIPC service is delivered by two community palliative care teams (CPCTs) through integrated professional working with community nursing teams (n=4) and general practices (n=4), and close working with geriatricians. The intervention involves referral to of the two CPCTs, comprehensive palliati; Follow Up Length: 3 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
5 key symptoms are measured using the integrated Palliative care Outcome Scale at baseline, 6 weeks and 12 weeks (primary end point). |
| Key secondary outcome measure(s) |
1. Assistance with activities of daily living is measured using the Barthel Index at baseline and 12 weeks |
| Completion date | 06/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 142 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Phase 1b: focus groups - Older adults living with frailty using one of the participating community groups or residing in the participating care home; or carers of older adults. Carers are either informal carers e.g. family member or a carer working as a volunteer for one of the participating charitable organisation supporting older people in community settings. Adults with capacity to give informed consent and communicate in English. 2. Stakeholder consultation participants comprise: service providers, commissioners and voluntary sector representatives from the study site. The purposive selection on the participants is based on: The services providers are health or social care practitioners providing community based services including: specialist palliative care, general practice, community nursing, end of life care facilitators, dementia services and social care. 3. The practitioners provide services in the locality of Sussex Community NHS Trust. 4. The commissioners are leads for end of life care services and are identified from the Care Commissioning Groups in the study site. 5. Voluntary sector representatives are local individuals representing local/national organisations supporting/advocating for older people. Phase 2: Adults aged 75 years over residing in the study site at home or in a care home (with or without nursing) severely affected by non-malignant advanced illness and/ frailty with or without dementia and not using specialist palliative care. Severely affected encompasses one or more unresolved symptoms, psychosocial concerns, EoL issues, progressive illness, complex needs or Gold Standards Framework (GSF) prognostication index for frailty and dementia. Participants are registered with one of the four GP practices participating in the study. Participation will be offered to older people with or without carers. The inclusion criteria are broad as uncertainty surrounds when a frail older person may most benefit from palliative care. The findings from phases 1a and 1b will further develop and refine the inclusion criteria. |
| Key exclusion criteria | Phase 2: Exclusion criteria Older people with malignant disease receiving curative or palliative treatment . |
| Date of first enrolment | 17/09/2014 |
| Date of final enrolment | 16/09/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Brighton General Hospital
Elm Grove
Brighton
BN2 3EW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from catherine.evans@kcl.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/08/2021 | 21/06/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version v1.7 | 19/11/2015 | 26/04/2021 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN45837097 Phase 2_Protocol_v1.7_19Nov2015.pdf
- Uploaded 26/04/2021
Editorial Notes
21/06/2021: Publication reference added.
27/04/2021: The recruitment start date has been changed from 06/01/2014 to 17/09/2014.
26/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 18/03/2016 to 16/09/2015.
2. The intention to publish date has been changed from 31/12/2016 to 31/05/2021.
3. The final enrolment number has been added.
4. Uploaded protocol Version 1.7 19 November 2015 2017 (not peer reviewed).
09/11/2016: The following changes have been made to the record:
1. The overall trial dates have been updated from 09/01/2014 - 04/11/2015 to 01/06/2013 - 06/05/2016 and the recruitment dates have been updated from 09/01/2014 - 04/11/2015 to 18/03/2016.
2. The interventions section has been updated
3. The outcome measures have been added
4. The publication and dissemination plan has been added
