Condition category
Respiratory
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes