OptCare: Optimising palliative care for older people in the community

ISRCTN	ISRCTN03393115
DOI	https://doi.org/10.1186/ISRCTN03393115
Protocol serial number	13275
Sponsor	King's College London
Funder	NIHR Trainees Coordinating Centre (UK)

Submission date: 10/10/2012
Registration date: 05/06/2013
Last edited: 07/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Catherine Evans
Scientific

King's College London
Cicely Saunders Institute
Bessemer Road
Denmark Hill
London
SE5 9PJ
United Kingdom

ORCID ID	0000-0003-0034-7402
Phone	+44 207 848 5579
Email	catherine.evans@kcl.ac.uk

Study information

Primary study design	Observational
Study design	Non-randomised observational cross-sectional study
Secondary study design	Non 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 intergrated service
Study acronym	OptCare
Study objectives	The aim of this study is to develop and evaluate the feasibility of the new STIPC service for frail older people in community settings (including care homes) delivered through integrated working between specialist palliative care services and community nursing teams, and close with GPs and geriatricians.
Ethics approval(s)	NRES Committee South East Coast - Brighton and Sussex, 24/09/2012, ref: 12/LO/1367
Health condition(s) or problem(s) studied	Primary Care Research Network / Palliative care
Intervention	The research methods follow the Medical Research Council guidance for the development and evaluation of complex interventions. Phase 1: Intervention development involves a post-bereavement survey to determine preferences for care and palliative care outcomes by place of death for older people (n=900); and a stakeholder consultation with recipients of care and service providers/commissioners, on the survey findings to develop the intervention and then, an on-line/postal survey on the proposed components and outcomes. Followed up at 2 months Phase 2: Participants were randomly allocated to intervention or control group following consent. The intervention arm involved a service delivered by two palliative care teams working with four community nursing teams in a single Community NHS Trust. The new service involved 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. The control arm received their usual care provided by their GP or community nursing team. After 12 weeks, this group were offered the intervention however there was no research follow-up for this group beyond the 12 weeks from consent. Both groups were given questionnaires to complete at baseline, 6 weeks and 12 weeks and the GP records were followed up for 6 months. The intervention group were also invited to take part in a qualitative interview after the 12 week study period.
Intervention type	Other
Primary outcome measure(s)	Primary outcome as of 05/07/2016: Five key symptoms are measured using the integrated Palliative care Outcome Scale at baseline, 6 weeks and 12 weeks (primary end point). Original primary outcome: Palliative care Outcome Scale
Key secondary outcome measure(s)	Secondary outcomes as of 05/07/2016: 1. Assistance with activities of daily living is measured using the Barthel Index at baseline and 12 weeks questionnaires 2. Performance status is measured using the Australia Karnofsky Index at baseline and 12 weeks questionnaires 3. Carer burden is measured using the Zarit carer burden at baseline and 12 weeks questionnaires 4. Service use and cost is measured/calculated using the Client Service Receipt Inventory at baseline and 12 weeks questionnaires 5. Survival is measured by reviewing GP medical records for mortality Original secondary outcomes: 1. Client Service Receipt Inventory 2. EQ5D 3. QUALYCare survey 4. Texas Revised Inventory of Grief
Completion date	06/05/2016

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	900
Key inclusion criteria	Inclusion criteria as of 07/07/2016: Phase one: 1. Older adults living with frailty using one of the participating community groups or residing in the participating care home; or 2. Carers of older adults (either informal carers e.g. family members or a carer working as a volunteer for one of the participating charitable organisation supporting older people in community settings) 3. Adults with capacity to give informed consent and communicate in English Phase two: 1. The service 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, providing services in the locality of Sussex Community NHS Trust 2. The commissioners are leads for end of life care services and are identified from the Care Commissioning Groups in the study site 3. Voluntary sector representatives are local individuals representing local/national organisations supporting/advocating for older people, e.g. Age UK, Alzheimer Society, Brighton and Hove Older People’s Council, Carers Centre Brighton and Hove Original inclusion criteria: Individuals who registered the death of a person who died: 1. In the study site 2. In the 4-10 months prior to survey administration 3. Aged 75 years and over 4. From cancer or selected non-malignant illness common in advanced age 5. Died in a community setting (e.g. at home, care home or hospice) or hospital 6. Male or female participants
Key exclusion criteria	1. Individual included in the National VOICES survey administered by Office for National Statistics (ONS) in 2012 2. Deaths where an informants address is missing 3. Deaths where an informant was an official (e.g. solicitor) or other identified person who would not be able to provide the required information
Date of first enrolment	06/01/2014
Date of final enrolment	18/03/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Sussex Community NHS Foundation Trust

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/07/2016: The inclusion criteria of the study have been updated.
05/07/2016: The recruitment dates have been updated from 15/10/2012 - 14/12/2012 to 06/01/2014 - 18/03/2016, and the overall trial end date has been updated from 14/12/2012 to 06/05/2016. In addition, the trial participating centre has been added (replacing King's College London) as well as the study contact's ORCID ID, availablility of participant level data, and addition of the interventions for the feasibility study. The outcome measures have also been updated.
24/06/2016: No publications found, verifying study status with principal investigator.