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

Multiple Sclerosis Clinical Trial

Official title:

Proposal to Create a Flagship Neurology and Palliative Care Service for South London

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364936
• Other study ID #: MS Society 676/01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 14, 2006
• Last updated: June 10, 2009
• Start date: March 2004
• Est. completion date: December 2006

Study information

• Verified date: June 2009
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Procedure:
• Palliative care service

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	National Multiple Sclerosis Society

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1186/1472-684X-7-7. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palliative Care Outcome Scale - Symptoms		12 weeks	No
Secondary	Self-reported quality of life		12 weeks	No
Secondary	Impact of MS		12 weeks	No
Secondary	Psychosocial palliative care outcomes		12 weeks	No
Secondary	use of health and social services		12 weeks	No
Secondary	Experience of hospital services		12 weeks	No
Secondary	Carer burden and satisfaction		12 weeks	No
Secondary	Costs (formal and informal)		12 weeks	No

External Links

•   Overview of programme of studies in the department of palliative care of which this study is part