Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00364936
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2006-08-14
Brief Title:
Development and Evaluation of a New Palliative Care Service for People Severely Affected With Multiple Sclerosis MS
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Proposal to Create a Flagship Neurology and Palliative Care Service for South London
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 25 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None