A randomised cross over trial of nurse versus doctor-led outpatient care in a bronchiectasis clinic

ISRCTN	ISRCTN55381079
DOI	https://doi.org/10.1186/ISRCTN55381079
Secondary identifying numbers	HTA 94/40/27

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 27/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Diana Bilton
Scientific

Cystic Fibrosis and Lung Defence Unit
Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Phone	+44 (0)1480 830 541 Ext 4697
Email	drdianabilton@cs.com

Study information

Study design	Randomised controlled cross-over trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	1. To assess the feasibility and safety of nurse led outpatient clinics. 2. To evaluate the acceptability of nurse led outpatient clinics to patients and GPs. 3. To compare the cost effectiveness of a nurse led and doctor led system of care. This is a cross over study of nurse led repeat visits for patients with bronchiectasis, following initial investigation and establishment of a care plan by a consultant physician. The initial phase (9-12 months) is essential to allow training of the nurse practitioner, and introduction of this concept to patients and general practitioners.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Respiratory tract diseases: Other respiratory tract disease
Intervention	For the first year of the study patients were randomised to receive either 1 year of nurse practitioner-led care or 1 year of doctor led care. The 2 groups then crossed over to receive the alternate mode of care for a further year. It was important the subjects received each mode of care for a whole year because chronic lung disease is subject to seasonal variation.
Intervention type	Other
Primary outcome measure	Primary outcome was lung function as measured by forced expiratory volume in 1 second (FEV1).
Secondary outcome measures	Secondary measures included walking distance, health related quality of life, nurse practitioner autonomy, patient and general practitioner satisfaction with communications and care, patient compliance with treatment and resource group
Overall study start date	01/07/1997
Completion date	30/11/2000

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	80
Key inclusion criteria	Patients over 18 years with moderate or severe bronchiectasis confirmed by high resolution computed tomography scans.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/07/1997
Date of final enrolment	30/11/2000

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cystic Fibrosis and Lung Defence Unit

Cambridge
CB3 8RE
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	HTA monograph	01/04/2002		Yes	No
Results article	results	01/08/2002		Yes	No