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

Status Completed

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.

Clinical Trial 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. ;

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

• NCT number: NCT00364936
• Study type: Interventional
• Source: King's College London
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2004
• Completion date: December 2006