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

Sponsor:	King's College London
Collaborator:	National Multiple Sclerosis Society
Information provided by:	King's College London
ClinicalTrials.gov Identifier:	NCT00364936

Purpose

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 I Phase II

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:

MedlinePlus related topics: Caregivers Multiple Sclerosis Palliative Care

U.S. FDA Resources

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364936

Locations

United Kingdom
King's College Hospital
London, United Kingdom, SE5 9RJ

Sponsors and Collaborators

King's College London

National Multiple Sclerosis Society

Investigators

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:

Overview of programme of studies in the department of palliative care of which this study is part This link exits the ClinicalTrials.gov site

Publications:

Higginson IJ, Hart S, Burman R, Silber E, Saleem T, Edmonds P. Randomised controlled trial of a new palliative care service: Compliance, recruitment and completeness of follow-up. BMC Palliat Care. 2008 May 28;7:7.

Higginson IJ, Hart S, Silber E, Burman R, Edmonds P. Symptom prevalence and severity in people severely affected by multiple sclerosis. J Palliat Care. 2006 Autumn;22(3):158-65.

Gruenewald DA, Higginson IJ, Vivat B, Edmonds P, Burman RE. Quality of life measures for the palliative care of people severely affected by multiple sclerosis: a systematic review. Mult Scler. 2004 Dec;10(6):690-704. Review.

Edmonds P, Vivat B, Burman R, Silber E, Higginson IJ. 'Fighting for everything': service experiences of people severely affected by multiple sclerosis. Mult Scler. 2007 Jun;13(5):660-7. Epub 2007 Feb 9.

Edmonds P, Vivat B, Burman R, Silber E, Higginson IJ. Loss and change: experiences of people severely affected by multiple sclerosis. Palliat Med. 2007 Mar;21(2):101-7.

Higginson IJ, Vivat B, Silber E, Saleem T, Burman R, Hart S, Edmonds P. Study protocol: delayed intervention randomised controlled trial within the Medical Research Council (MRC) Framework to assess the effectiveness of a new palliative care service. BMC Palliat Care. 2006 Oct 2;5:7.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Higginson IJ, Costantini M, Silber E, Burman R, Edmonds P. Evaluation of a new model of short-term palliative care for people severely affected with multiple sclerosis: a randomised fast-track trial to test timing of referral and how long the effect is maintained. Postgrad Med J. 2011 Nov;87(1033):769-75. Epub 2011 Oct 6.

Higginson IJ, McCrone P, Hart SR, Burman R, Silber E, Edmonds PM. Is short-term palliative care cost-effective in multiple sclerosis? A randomized phase II trial. J Pain Symptom Manage. 2009 Dec;38(6):816-26.

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
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
hospice
end-of-life

symptom control
evaluation
effectiveness

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012