Clinical and cost effectiveness of short-term integrated palliative care services to optimise care for people with advanced long-term neurological conditions
- Conditions
- Topic: Dementias and neurodegeneration, Neurological disordersNervous System Diseases
- Registration Number
- ISRCTN18337380
- Lead Sponsor
- King's College London
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32857151/ results (added 02/09/2020) 2017 Other publications in https://pubmed.ncbi.nlm.nih.gov/28774963/ (added 15/02/2023) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32902934/ (added 15/02/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 350
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) 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
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 symptoms (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 an 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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measures as of 01/02/2017:<br> 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<br><br> Previous primary outcome measures:<br> A combined score of key symptoms, measured at 12 weeks post randomisation<br>
- Secondary Outcome Measures
Name Time Method