Development and Evaluation of a New Palliative Care Service for People Severely Affected With Multiple Sclerosis (MS)
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ClinicalTrials.gov Identifier: NCT00364936 |
Recruitment Status
:
Completed
First Posted
: August 16, 2006
Last Update Posted
: June 11, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Procedure: Palliative care service | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Proposal to Create a Flagship Neurology and Palliative Care Service for South London |
Study Start Date : | March 2004 |
Study Completion Date : | December 2006 |

- Palliative Care Outcome Scale - Symptoms [ Time Frame: 12 weeks ]
- Self-reported quality of life [ Time Frame: 12 weeks ]
- Impact of MS [ Time Frame: 12 weeks ]
- Psychosocial palliative care outcomes [ Time Frame: 12 weeks ]
- use of health and social services [ Time Frame: 12 weeks ]
- Experience of hospital services [ Time Frame: 12 weeks ]
- Carer burden and satisfaction [ Time Frame: 12 weeks ]
- Costs (formal and informal) [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364936
United Kingdom | |
King's College Hospital | |
London, United Kingdom, SE5 9RJ |
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 |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Prof I Higginson - Prinical investigator responsible, King's College London |
ClinicalTrials.gov Identifier: | NCT00364936 History of Changes |
Other Study ID Numbers: |
MS Society 676/01 |
First Posted: | August 16, 2006 Key Record Dates |
Last Update Posted: | June 11, 2009 |
Last Verified: | June 2009 |
Keywords provided by King's College London:
palliative care hospice end-of-life |
symptom control evaluation effectiveness |
Additional relevant MeSH terms:
Sclerosis Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |