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

June 10, 2009 updated by: King's College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Palliative Care Outcome Scale - Symptoms
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

August 14, 2006

First Submitted That Met QC Criteria

August 14, 2006

First Posted (ESTIMATE)

August 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2009

Last Update Submitted That Met QC Criteria

June 10, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS Society 676/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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