Development and Evaluation of a New Palliative Care Service for People Severely Affected With Multiple Sclerosis (MS)

This study has been completed.
National Multiple Sclerosis Society
Information provided by:
King's College London Identifier:
First received: August 14, 2006
Last updated: June 10, 2009
Last verified: June 2009
The primary purpose of this study is to develop, implement and conduct a preliminary evaluation of a new service for people who are severely affected by multiple sclerosis. The investigators conducted open interviews with patients, families and staff, plus a literature review to model and pilot this new service. Then the investigators developed, tested and ran the service and will evaluate it using a randomised controlled trial, where people affected by MS are randomised to either receive the service immediately (fast track group) or after a three month wait (standard best practice). This methodology follows that of the Medical Research Council (MRC) framework for the development and evaluation of complex services and treatments. The investigators interview people and their carers in the fast track and standard practice groups, and followed them over time. This phase of trial enables us to calculate sample size and test proof of concept for a full randomised trial. However, our working hypothesis was that there would be no difference between those people who received the fast track service or the standard best practice in terms of symptom controlled, and carer needs.

Condition Intervention Phase
Multiple Sclerosis
Procedure: Palliative care service
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proposal to Create a Flagship Neurology and Palliative Care Service for South London

Resource links provided by NLM:

Further study details as provided by King's College London:

Primary Outcome Measures:
  • Palliative Care Outcome Scale - Symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Impact of MS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Psychosocial palliative care outcomes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • use of health and social services [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Experience of hospital services [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Carer burden and satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Costs (formal and informal) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: March 2004
Estimated Study Completion Date: December 2006
Detailed Description:

Palliative care has been proposed to help meet the needs of patients who suffer progressive non-cancer conditions but this has not been tested. Multiple sclerosis is a chronic disease affecting the central nervous system affecting over 2.5 million people worldwide, and is the commonest cause of neurological disability in adults under 60 years. It is associated with a wide spectrum of physical symptoms, including loss of function of legs, arms and in many instances bladder and bowel dysfunction, pain, spasms, swallowing and communication and cognitive difficulties, many of which are as severe as among patients with cancer. Therefore it seems appropriate to try to develop palliative care services for this group of patients.

Our design followed the MRC Framework for the Evaluation of Complex Interventions. The investigators modelled a new palliative care and neurology service for patients affected by Multiple Sclerosis (MS) by conducting qualitative interviews with patients, families and staff, plus a literature review to model and pilot the service. Then the investigators started to offer the service and designed a delayed intervention randomised controlled trial to test its effectiveness as part of phase II of the MRC framework. Inclusion criteria for the trial were patients identified by referring clinicians as having unresolved symptoms or psychological concerns. A disability of scoring greater than 8 on the Expanded Disability Scale was identified as a benchmark. Consenting patients newly referred to the new service were randomised to either receive the palliative care service immediately (fast-track) or after a 12-week wait (standard best practice). Face to face interviews were conducted at baseline (before intervention), and at 4-6, 10-12 (before intervention for the standard-practice group), 16-18 and 22-24 weeks with patients and their carers using standard questionnaires to assess symptoms, palliative care outcomes, function, service use and open comments. The investigators choice of outcomes was based on a systematic literature review of outcome measures.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of MS
  • Living in South East London
  • Having possible palliative care needs. Referrers were encouraged to identify people as severely affected with MS based on their clinical need, rather than relying on any standardised measures of disability. However, since a large Canadian population study identified that approximately 15% of people with MS have an Expanded Disability Scale Score of 8 or more (out of a possible 10)23, this was also suggested to referrers as a benchmark for disability that would prompt consideration of referral. Examples of palliative care needs were given as unresolved symptoms, psychosocial concerns, and end of life issues, progressive illness or complex needs.

Exclusion Criteria:

  • patients deemed as having urgent needs (following independent review by a consultant in palliative medicine) because of rapid deterioration or severe symptoms - these were seen immediately by the service.
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Please refer to this study by its identifier: NCT00364936

United Kingdom
King's College Hospital
London, United Kingdom, SE5 9RJ
Sponsors and Collaborators
King's College London
National Multiple Sclerosis Society
Principal Investigator: Polly Edmonds, FRCP King's College Hospital / King's College London
Study Chair: Irene J Higginson, BMBS FRCP FFPHM PhD King's College London
  More Information

Additional Information:
Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof I Higginson - Prinical investigator responsible, King's College London Identifier: NCT00364936     History of Changes
Other Study ID Numbers: MS Society 676/01 
Study First Received: August 14, 2006
Last Updated: June 10, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by King's College London:
palliative care
symptom control

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes processed this record on February 10, 2016