The impact of social action services on end of life experience
| ISRCTN | ISRCTN12929812 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12929812 |
| Secondary identifying numbers | 18742 |
- Submission date
- 20/05/2015
- Registration date
- 20/05/2015
- Last edited
- 14/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
End of life care is support given to people who are considered likely to die within the next 12 months. The aim of end of life care is to improve the quality of life of the patient, and also to provide support to their family or carers. End of life care also includes palliative care given to patients with an incurable illness. There is a need to provide services which use the Social Action Model to support end of life care in community settings. The goal of the Social Action Model is to enable everybody to have access to community resources, and also to engage members of the community to help give back to society (e.g. by volunteering). Such services could work to reduce patient isolation, help meet emotional needs and maintain a sense of connectedness to the community. It is also important to robustly evaluate these models to see if they have a positive influence on the patient experience of end of life care. The UK Cabinet Office’s Centre for Social Action proposed, and launched, The Social Action End of Life Support Fund which aims to support a range of social action initiatives, including befriending (e.g. companionship, emotional and peer support), practical support (e.g. house/garden work, walking pets, picking up prescriptions) and provision of information/navigation towards relevant services. The aim of this study is to see what impact access to projects associated with the The Social Action End of Life Support Fund has on the quality of life of people in the last year of life.
Who can participate?
Adults in the last year of life.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given access to volunteer-provided Social Action services straight away following any service related administrative procedures. Those in group 2 (control group) are put on a 4 week waitlist before being given access to volunteer-provided Social Action services. The impact of having access to the Social Action services intervention on end of life experience (i.e. quality of life, loneliness, social support and carer burden) is measured using a predetermined set of outcome measurement tools in the form of an A4 self-reporting questionnaire booklet. Repeated assessments are carried out at weeks 4 and 8 for the intervention group, and at weeks 4, 8 and 12 for the control group. A selection of participating end of life care sites are selected for case study evaluation. These sites have interviews, observation and documentary analyses to understand the mechanisms underpinning any found impact on patient quality of life.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
1. Saint Michael’s Hospice (UK)
2. Aquarius (UK)
3. Peace Hospice (UK)
4. St Joseph’s Hospice (UK)
5. Hampshire Hospitals NHS Foundation Trust (UK)
6. Six Sue Ryder hospices across the UK
When is the study starting and how long is it expected to run for?
April 2015 to June 2016
Who is funding the study?
Cabinet Office (UK)
Who is the main contact?
Dr C Walshe
Contact information
Public
Lancaster University
International Observatory on End of Life Care
Furness Building
Lancaster
LA1 4YW
United Kingdom
Study information
| Study design | Randomised interventional process of care study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | End-of-Life Social Action Study (ELSA): a randomised wait-list controlled trial and embedded qualitative case study evaluation assessing the causal impact of social action services on end-of-life experience |
| Study acronym | ELSA |
| Study hypothesis | Receiving care from a social action volunteer service plus usual care significantly improves patient quality of life in the last year of life. |
| Ethics approval(s) | NRES Committee Yorkshire & The Humber - South Yorkshire, 12/03/2015, ref: 15/YH/0206. |
| Condition | Health services and delivery research |
| Intervention | 1. Intervention group: patients are given access to volunteer-provided social action services at the end of life tailored to individual needs of patients e.g. befriending, social support straight away. 2. Control group: patients are put on a 4 week waitlist before being given access to the volunteer-provided social action services. |
| Intervention type | Other |
| Primary outcome measure | The World Health Organization Quality of Life (WHOQOL)-BREF questionnaire will be used at baseline, 4 weeks and 8 weeks in the intervention group. For the control group, the WHOQOL-BREF will be used at baseline, 4 weeks, 8 weeks and 12 weeks. |
| Secondary outcome measures | Taken at baseline, 4 weeks and 8 weeks in the intervention group. For the control group, the measures are taken at baseline, 4 weeks, 8 weeks and 12 weeks: 1. Loneliness is measured using the De John Greiveld 6-item Loneliness Scale, a short, well-used, reliable and valid measurement instrument for overall, emotional, and social loneliness, chosen for brevity and relevance of the items when mapped onto anticipated outcomes 2. Social Support is measured using the 8-item modified Medical Outcomes Study Social Support Survey (mMOS-SS), a short validated scale covering two domains (emotional and instrumental social support) designed to identify potentially modifiable social support deficits, chosen for brevity and relevance of the items when mapped onto anticipated outcomes 3. Carer Burden is measured using the Caregiver Burden Scale-End of Life Care (CBS-EOLC), a reliable and valid measurement tool designed to specifically assess family caregivers’ burden within the palliative care context, chosen for brevity and relevance of the items when mapped onto anticipated outcomes Social network (network size, number of confidante, number and percentage of relatives in network and number and type of main helpers) will also be measured as mediator/moderator (not outcome) using an adapted Hirsch matrix. Socio-demographic data (age, gender, disease diagnosis, education, marital status, living status, spirituality and ethnicity) in the form of a questionnaire will be collected from both patients and informal carers at baseline. |
| Overall study start date | 30/04/2015 |
| Overall study end date | 01/06/2016 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | UK Sample Size: 700 |
| Participant inclusion criteria | Sites participating in this study will be selected as part of a government Cabinet Office funded initiative to support social action at the end of life in England. Twelve sites that provide these services will be shortlisted for interview. Selection considerations at shortlisting and interview will include the sites’ match to the tender, their capacity to deliver the proposed service, and their ability and willingness to contribute to the evaluation of these services. All sites will be made aware at interview that they are providing their services in the context of this study design (wait list RCT and case study evaluation). Patient inclusion criteria: 1. Those eligible to be referred to an end of life care service determined by the referring organisation/individual. They should be able to answer 'no' to the 'surprise question': ‘would you be surprised if the patient dies within a year?’ 2. Able to give informed consent Carer inclusion criteria 1. Those identified by participating patients as people who provide lay or unpaid support. These may be family, friends or other informal carers 2. Able to give informed consent Volunteer/staff inclusion criteria (for interview): 1. Those volunteering for a participating befriending service, and providing support to a trial participant (who was allocated to either trial arm) OR those working for a participating befriending service who are involved in the provision or management of these services 2. Able to give informed consent |
| Participant exclusion criteria | Patient exclusion criteria: 1. Age <18 2. Those who only who only understand or speak a language in which our main outcome measure (the WHOQOL BREF) is unavailable. This is anticipated to be a very small number of potential participants as the WHOQOL BREF is available in a wide range of languages, including the main languages spoken in the participating sites 3. Those with an anticipated prognosis of <4 weeks Carer exclusion criteria: 1. Age <18 years 2. Those who only who only understand or speak a language in which our carer outcome measure is unavailable |
| Recruitment start date | 08/06/2015 |
| Recruitment end date | 08/01/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Hornbeam Park Avenue
Harrogate
HG2 8QL
United Kingdom
Birmingham
B5 7SL
United Kingdom
Watford
WD17 3PH
United Kingdom
London
E8 4SA
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Leckhampton
Cheltenham
GL53 0QJ
United Kingdom
Oxenhope
BD22 9HJ
United Kingdom
Nettlebed
Henley on Thames
RG9 5DF
United Kingdom
Moggarhanger
MK44 3RJ
United Kingdom
Peterborough
PE3 6LW
United Kingdom
Leeds
LS6 2AE
United Kingdom
Sponsor information
Hospital/treatment centre
Research Support Office B58
Bowland Main
Bailrigg
Lancaster
LA1 4YT
England
United Kingdom
"ROR" |
https://ror.org/04f2nsd36 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Results of the research will be made available to research participants and the communities and sites from which they are drawn. A written summary of the results of the study will be distributed to all participating referring agencies and relevant community groups. Oral presentation of the results to the relevant local professional and social action communities will be arranged. Submissions to peer reviewed conferences and journals to disseminate findings of this project in an accessible way will also be performed. |
| IPD sharing plan | Patient level data are stored in the ELSA database developed by the study authors on a secure server maintained by Lancaster University. Catherine Walshe may be contacted to forward requests for data sharing which may be possible for some of the trial datasets, but consent was not given by participants to share some data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/07/2016 | Yes | No | |
| Results article | results | 09/12/2016 | Yes | No | |
| Results article | 29/03/2018 | 14/06/2023 | Yes | No |
Editorial Notes
14/06/2023: Publication reference added.
05/04/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 15/04/2016 to 01/06/2016.
2. Publication reference added.
14/07/2016: Publication reference added.
22/04/2016: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2015 to 08/06/2015.
2. The recruitment end date was changed from 31/12/2015 to 08/01/2016.
3. The overall trial end date was changed from 30/12/2015 to 15/04/2016.
