Clinical and cost­ effectiveness of short-­term integrated palliative care ... | Not Recruiting
Clinical and cost­ effectiveness of... | Not Recruiting
Clinical and cost­ effectiveness of short-­term integrated palliative care services to optimise care for people with advanced long-­term neurological conditions
OPTCARE Neuro

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Medical Conditions
  • Topic: Dementias and neurodegeneration, Neurological disorders
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN18337380
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 (multiple sclerosis, motor neurone disease, idiopathic Parkinson’s disease, progressive supranuclear palsy and multiple system atrophy) 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?
The study is designed to find out whether short-term palliative care offers any clinical benefit to people affected by long-term neurological conditions. It is not known whether those taking part will benefit or not and the results will help to answer that question and help people in the future. Taking part in interviews and completing questionnaires requires some time. Talking about personal experiences can be a relief or a challenge. Sometimes people find it upsetting to share what is happening in their lives. If that happens, interviews can be paused or stopped. Equally, many people find it helpful to talk in confidence about what is happening to them.

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 July 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Nilay Hepgul
nilay.hepgul@kcl.ac.uk
Research Details
  • 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).
Phase
Sorry, this information is not available
Study Design
Randomised; Interventional
Study Type
Interventional
Intervention

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.

Intervention Type
Other
Primary Outcome Measures
    Current primary outcome measures as of 01/02/2017:
    A combined score of 8 key items from the Integrated Palliative care Outcome Scale for neurological conditions (IPOS Neuro-S8), measured at 12 weeks post randomisation

    Previous primary outcome measures:
    A combined score of key symptoms, measured at 12 weeks post randomisation
Secondary Outcome Measures
    Current secondary outcome measures as of 01/02/2017:
    1. Patients’ other symptoms and palliative care needs, measured using the Integrated Palliative care Outcome Scale for neurological conditions (IPOS Neuro)
    2. Patients’ health-related quality of life and well-being, measured using the EuroQoL (EQ-5D) and the ICEpop Capability measure for Adult (ICECAP-A)
    3. Patients’ psychological distress, measured using the Hospital Anxiety and Depression Scale (HADS)
    4. Patients’ satisfaction, self-efficacy and other aspects, measured using the Modified 16-item measure of patient satisfaction (FAMCARE-P16) and the Self-Efficacy to Manage Chronic Disease Scale (SEMCD)
    5. Hospital admissions, length of hospital stay, emergency attendance, survival from consent and deaths and other service use during the course of the study, measured using the Client Service Recipient Inventory (CSRI)
    6. Caregiver burden and positivity and quality of life, measured using the 12-item Zarit Burden Inventory (ZBI-12) + positivity, the Veterans Rand 12-item Health survey (VR-12) and the Modified 17-item measure of carer satisfaction (FAMCARE2)
    7. Caregiver assessment of patients’ outcomes, measured using some of the same measures (IPOS Neuro & IPOS Neuro-S8)
    8. Observer (completed by the researcher) assessment of the patients’ problems, measured using the 6-item Cognitive Impairment Test (6CIT), Modified Fried’s Frailty Criteria, the Northwick Park Dependency Scale (NPDS), the Expanded Disability Status Scale (EDSS), the Australian modified Karnofsky Performance Status (AKPS) and the Support Team Assessment Schedule (STAS)
    Patients will be assessed for these outcomes at baseline, 6, 12, 18, 24 weeks

    Previous 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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Mixed
Number of Participants
Planned Sample Size: 356; UK Sample Size: 356
Participant Inclusion Criteria
    Patients:
    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)[5] 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)[7] stages 3-5
    1.3. Motor Neurone Disease (MND) all stages
    AND
    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.
    AND
    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.
    AND
    4. Are living in the catchment area of the Short-term Integrated Palliative Care Service (SIPC)

    Patients are expected 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. A proforma will be developed for referring clinicians to complete (covering contact and clinical information and important reasons for referral/selection).

    Caregivers:
    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

    Notes:
    * 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
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
King's College Hospital
London
SE5 9RS
Nottingham
Nottinghamshire
NG5 1PB
Liverpool
L9 7LJ
Brighton General Hospital
Brighton
BN2 3EW
Lyne
KT16 0QA
Longcross Street
Cardiff
CF24 0SZ
Trial Contact(s)
Primary Trial Contact
Dr Nilay Hepgul
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
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)
EudraCT Number
Sorry, this information is not available
Funder(s)
  • National Institute for Health Research
Other Study ID Numbers
18030
Sponsor(s)
King's College London ; King’s College Hospital
Key Dates

Recruitment Start Date

09 Jan 2015

Recruitment End Date

31 Oct 2017

Trial Start Date

09 Jan 2015

Trial End Date

31 Jul 2018

Date added to source

21 Jan 2015

Date updated in source

24 Jul 2017