Contact information
Type
Scientific
Primary contact
Dr Michael Barnes
ORCID ID
Contact details
Newcastle City Health NHS Trust
Hunters Moor Rehabilitation Centre
Hunters Road
Newcastle upon Tyne
NE2 4NR
United Kingdom
+44 (0)191 261 0895
m.p.barnes@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NYRHA WJML r135/05292
Study information
Scientific title
Acronym
Study hypothesis
A properly trained outreach nurse practitioner can provide a service that is as good as or better than that provided at a hospital outpatient clinic for people with chronic neurological disability.
The pilot population that is to be used to test this hypothesis is individuals with Parkinson's disease and dystonia attending Hunters Moor Regional Rehabilitation Centre in Newcastle upon Tyne. All patients attending the movement disorder clinic at Hunters Moor will be eligible for participation in the study.
We anticipate the hypothesis will be proven and that a properly trained nurse practitioner is able to provide a more satisfactory support service for people with the pilot condition both from the patients and general practitioners perspectives. If the hypothesis is proven the project will benefit the NHS as the patient will not need to make unnecessary journeys to hospital, the primary care team will be involved more effectively in the management of the individual, the specialist will see individuals at the time when such referral is required and the purchaser should get better value for money.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Parkinson's disease
Intervention
After informed consent patients will be randomly divided into two groups with approximately 75 individuals in each group.
1. Standard attendance of outpatients
This group will continue to attend regular outpatient assessment at Hunters Moor as previously.
2. Visited at home by an outreach nurse practitioner
This group will not attend outpatients but will be visited at home by an outreach nurse practitioner. The group will have regular access to the nurse practitioner who will act a primary contact point for the disabled person and the family. The nurse practitioner will be responsible for liaison with the general practitioner and primary care team and for referral to the hospital consultant and members of the multi-disciplinary rehabilitation team as necessary. The consultant and multi-disciplinary team members will be able to assess the client and carer either at home or in the hospital. The nurse practitioner, within agreed protocols, would advise the patient on adjusting drug dosages and be responsible for the administration of botulinum toxin injections for individuals with dystonia.
The practitioner will provide educational material, advice and ongoing support for the patient and carer.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The effectiveness of this model of care will be assessed by a number of means including
1. Assessment of disability status measured by a number of appropriate scales
1.1. general practitioner and primary care team satisfaction questionnaires
1.2. comparison of attendances at hospital and general practitioner
1.3. record of complications
1.4. record of drug and other medical management employed during the study period
2. Satisfaction questionnaires will be administered to the patient and carer and their psychological status will also be measured using the General Health Questionnaire.
3. A brief questionnaire will be designed that records the extent and level of knowledge and understanding of the disease and associated disabilities. This questionnaire will be administered to the client and carer.
4. An economic analysis will also be undertaken of the costs involved in both arms of the study.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
08/01/1995
Overall trial end date
31/07/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients attending the movement disorder clinic at Hunters Moor
2. Being treated for Parkinson's and dystonia
3. Informed consent
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
08/01/1995
Recruitment end date
31/07/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle City Health NHS Trust
Newcastle upon Tyne
NE2 4NR
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11295008
Publication citations
-
Results
Whitaker J, Butler A, Semlyen JK, Barnes MP, Botulinum toxin for people with dystonia treated by an outreach nurse practitioner: a comparative study between a home and a clinic treatment service., Arch Phys Med Rehabil, 2001, 82, 4, 480-484, doi: 10.1053/apmr.2001.21843.