Outreach management of people with chronic neurological disability.

ISRCTN	ISRCTN85664035
DOI	https://doi.org/10.1186/ISRCTN85664035
Protocol serial number	NYRHA WJML r135/05292
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 17/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Michael Barnes
Scientific

Newcastle City Health NHS Trust
Hunters Moor Rehabilitation Centre
Hunters Road
Newcastle upon Tyne
NE2 4NR
United Kingdom

Phone	+44 (0)191 261 0895
Email	m.p.barnes@ncl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/1997

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	1. Patients attending the movement disorder clinic at Hunters Moor 2. Being treated for Parkinson's and dystonia 3. Informed consent
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	08/01/1995
Date of final enrolment	31/07/1997

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Newcastle City Health NHS Trust

Newcastle upon Tyne
NE2 4NR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2001		Yes	No