Contact information
Type
Scientific
Primary contact
Dr Diana Bilton
ORCID ID
Contact details
Cystic Fibrosis and Lung Defence Unit
Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
+44 (0)1480 830 541 Ext 4697
drdianabilton@cs.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/40/27
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration.
Study design
Randomised controlled cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/07/1997
Overall trial end date
30/11/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients over 18 years with moderate or severe bronchiectasis confirmed by high resolution computed tomography scans.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/07/1997
Recruitment end date
30/11/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cystic Fibrosis and Lung Defence Unit
Cambridge
CB3 8RE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (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
2002 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/12433318
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12149523
Publication citations
-
HTA monograph
Caine N, Sharples LD, Hollingworth W, French J, Keogan M, Exley A, Hodgkins D, Bilton D, A randomised controlled crossover trial of nurse practitioner versus doctor-led outpatient care in a bronchiectasis clinic., Health Technol Assess, 2002, 6, 27, 1-71.
-
Results
Sharples LD, Edmunds J, Bilton D, Hollingworth W, Caine N, Keogan M, Exley A, A randomised controlled crossover trial of nurse practitioner versus doctor led outpatient care in a bronchiectasis clinic., Thorax, 2002, 57, 8, 661-666.