Plain English Summary
Background and study aims
Long-term neurological conditions (LTNCs) are a group of progressive disorders, affecting approximately 10 million people in the UK. People with LTNCs commonly have physical disabilities affecting arms, legs, bladder, bowel, eyesight, or speech, for example, plus other intractable symptoms including pain spasms and fatigue. In addition, there is often a double burden of psychological distress or cognitive dysfunction. Over one third of people with LTNCs are estimated to need help with daily living, and nearly one million informal carers support someone with a neurological disease. Earlier phases of neurological illness can be managed well with medical treatments, rehabilitation, care and support. However, some diseases are or become invariably progressive. In the later stages those affected experience increased problems with greater need for personal, social, psychological and spiritual support. Care needs for those severely affected by LTNCs rise sharply once the disease reaches more advanced stages. Research has shown that these are not managed well by existing standard care; patients live with continuing symptoms, emotional and social problems. Their families also carry increasing burdens. While costs to the NHS increase, not all the care given is experienced as appropriate according to reports from some patients and families, with failures in coordination between acute and community care. Palliative care addresses the needs of the whole person – physical, emotional, social and spiritual. Specialists in palliative care have trained in these specific aspects, and how to communicate well during difficult times. They work in multi-professional teams, in-patient hospices, hospitals, care-homes and in home care. Palliative care has been suggested in NHS policy documents, such as the National Service Framework for LTNCs (quality standard 9) as a way to better help people severely affected by long-term neurological conditions, but it has not been rigorously tested. There is also uncertainty about when to introduce palliative care. Palliative care services are unevenly distributed, many managing on voluntary funding. Primary Care Trust spend on specialist palliative care ranges from £186 to £6,213 per death, with most of their funding supporting cancer patients. Without robust evidence about the best models of providing palliative care for people with long-term neurological conditions, it is very unlikely that palliative care services will be offered appropriately. In this study we aim to find out whether offering Short-term Integrated Palliative Care Services (SIPC) to people affected by neurological conditions and in several centres can improve their care experience, particularly regarding management of pain and symptoms but also quality of life, anxiety and depression, communication, and caregiver burden. It will also consider whether SIPC may be more cost-effective than standard care, or affects hospital admissions.
Who can participate?
Adults (aged 18 years or over) severely affected by advanced or progressive stages of one of a number of neurological conditions and their caregivers.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given standard care plus SIPC. Those in group 2 are given standard care. Participants and their caregivers who agree to take part in the study are asked to participate in a series of interviews to complete questionnaires (about symptoms, quality of life, mood and services received) at the start of the study, then at 6, 12, 18 and 24 weeks into the study. We collect information about hospital admissions, services used and survival from clinical records. Throughout the study about every 6 months we produce a newsletter to keep everyone up to date. We are analysing some results as we go (such as the problems that patients and families have before they start the study) but the main trial analysis is completed at the end of follow-up when we have collected the information. After 12 weeks participants in group 2 are also offered SIPC, so in the end, everyone will receive the SIPC.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Cicely Saunders Institute, King's College London (UK)
When is the study starting and how long is it expected to run for?
January 2015 to December 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Miss Debbie Tonkin
Evaluation of the clinical and cost effectiveness of Short-term Integrated Palliative Care Services (SIPC) to OPTimise CARE for people with advanced long-term Neurological conditions (OPTCARE Neuro)
The purpose of this study is to determine the effectiveness and cost-effectiveness of Short-term Integrated Palliative Care Services (SIPC) in improving symptoms, selected patient and caregiver reported outcomes and reducing hospital utilisation for people severely affected by long-term neurological conditions (LTNCs)
NRES Committee London - South East, 09/12/2014, ref:14/LO/1765
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Topic: Dementias and neurodegeneration, Neurological disorders
Participants will be randomly allocated to either receiving the intervention immediately or after a (approximately) 12 week waiting period (after the second interview is completed and reviewed). The intervention consists of short-term Integrated Palliative Care (SIPC) offered to patients severely affected by long-term neurological conditions, lasting for 6-8 weeks from referral. SIPC will be delivered by existing multiprofessional palliative care team (MPCT), linked with local neurology and rehabilitation services. All participants are followed up for 24 weeks with interview points at baseline, 6,12,18 and 24 weeks.
Primary outcome measures
A combined score of key symptoms, at 12 weeks post randomisation
Secondary outcome measures
1. Patients’ other symptoms and palliative care needs
2. Patients’ health-related quality of life and well-being
3. Patients’ psychological distress
4. Patients’ satisfaction, self-efficacy and other aspects
5. Hospital admissions, length of hospital stay, emergency attendance, other service use during the course of the study, survival from consent and deaths
6. Caregiver burden and positivity and quality of life
7. Caregiver assessment of patients’ outcomes using some of the same measures
8. Observer (completed by the researcher) assessment of the patients’ problems
Patients will be assessed for these outcomes at baseline, 6, 12, 18, 24 weeks
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Adults (aged 18 years or over) severely affected by advanced or progressive stages of the long-term neurological conditions (LTNCs) of either*:
1.1. Multiple Sclerosis (MS) - patients with either aggressive relapsing disease with rapid development of fixed disability or those with advanced primary or secondary progressive disease, often with limitation in a number of areas including gait and upper limb function. We do not define referral based on disability but would expect most patients to have an Expanded Disability Status Scale (EDSS) of at least 7.5.
1.2. Parkinsonism & related disorders (PRDs) i.e.
1.2.1. Idiopathic Parkinson’s Disease(IPD), Hoehn and Yahr(H&Y) stages 4-5 OR
1.2.2. Progressive Supranuclear Palsy(PSP) Hoehn and Yahr(H&Y) stages 3-5 OR
1.2.3. Multiple System Atrophy(MSA) - Hoehn and Yahr(H&Y) stages 3-5
1.3. Motor Neurone Disease (MND) all stages
2. Who are deemed (by referring/usual care clinicians) to have:
2.1. An unresolved symptom (e.g. pain or another symptom) which has not responded to usual care
2.2. AND at least one of the following: unresolved other symptom (e.g. breathlessness, nausea / vomiting, spasticity, fatigue); cognitive problems; complex psychological (depression, anxiety, loss, family concerns), communication/information problems and/or complex social needs.
3. Who are able to give informed consent^ OR where their capacity can be enhanced^ (e.g. with information) so they can give informed consent OR where a personal consultee^ can be identified and approached to give a opinion on whether or not the patient would have wished to participate in the study.
4. Are living in the catchment area of the Short-term Integrated Palliative Care Service (SIPC)
We expect patients to be in the advanced or progressive stages of disease. They may be living at home (most common), in a nursing home or in hospital at the time of recruitment. We will develop a proforma for referring clinicians to complete (covering contact and clinical information and important reasons for referral/selection).
1. Adults (aged 18 years or over) identified by the patient as the person closest to them, usually a family member, close friend, informal caregiver or neighbour.
2. Able to give informed consent to complete the questionnaires
* Diagnosis must have been established by a specialist neurological assessment
^ When a person lacks capacity to consent for themselves the procedures detailed in the Mental Capacity Act (2005) are adhered to.
Target number of participants
Planned Sample Size: 356; UK Sample Size: 356
Participant exclusion criteria
Patients who meet the inclusion criteria but:
1. Are already receiving specialist palliative care
2. Lack capacity and have no family member, friend or informal caregiver who is willing and available to complete questionnaires about their own and the patient’s symptoms and circumstances
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
King's College London
Palliative Care, Policy & Rehab Cicely Saunders Institute Bessemer Road
King's College London
Waterloo JCMB 5.21 5th Floor
King’s College Hospital
Research and Development Department
King's College Hospital NHS Foundation Trust
161 Denmark Hill
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
It is intended that the results of the trial will be reported and disseminated at national and international conferences, and in peer-reviewed scientific journals. Data from all centres will be analysed together and published as soon as possible. We aim to publish the protocol in a (peer-reviewed) journal and to make it available in accordance with NIHR guidance. Efforts will be made to send a summary of results to participants once they become available. Wider public dissemination will be facilitated by patient and service user representatives, who will form part of the SSC and we will form a separate PPI committee.
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting