NCT00364936

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P75+ for phase_1 multiple-sclerosis

Timeline
Completed

Started Mar 2004

Typical duration for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

First QC Date

August 14, 2006

Last Update Submit

June 10, 2009

Conditions

Multiple Sclerosis

Keywords

palliative carehospiceend-of-lifesymptom controlevaluationeffectiveness

Outcome Measures

Primary Outcomes (1)

  • Palliative Care Outcome Scale - Symptoms

    12 weeks

Secondary Outcomes (7)

  • Self-reported quality of life

    12 weeks

  • Impact of MS

    12 weeks

  • Psychosocial palliative care outcomes

    12 weeks

  • use of health and social services

    12 weeks

  • Experience of hospital services

    12 weeks

  • +2 more secondary outcomes

Interventions

Palliative care servicePROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, London, SE5 9RJ, United Kingdom

Location

Related Publications (8)

  • 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. doi: 10.1191/1352458504ms1116rr.

    PMID: 15584496BACKGROUND

  • 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. doi: 10.1177/1352458506071789. Epub 2007 Feb 9.

    PMID: 17548447BACKGROUND

  • 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. doi: 10.1177/0269216307076333.

    PMID: 17344258BACKGROUND

  • 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. doi: 10.1186/1472-684X-5-7.

    PMID: 17014714BACKGROUND

  • 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.

    PMID: 18507817RESULT

  • 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.

    PMID: 17058754RESULT

  • 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. doi: 10.1136/postgradmedj-2011-130290. Epub 2011 Oct 6.

    PMID: 21978993DERIVED

  • 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. doi: 10.1016/j.jpainsymman.2009.07.002.

    PMID: 19833477DERIVED

Related Links

MeSH Terms

Conditions

Multiple SclerosisDeath

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Polly Edmonds, FRCP

    King's College Hospital / King's College London

    PRINCIPAL INVESTIGATOR

  • Irene J Higginson, BMBS FRCP FFPHM PhD

    King's College London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 16, 2006

Study Start

March 1, 2004

Study Completion

December 1, 2006

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

GB(1)