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 |
| Protocol serial number | HTA 94/40/27 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
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 |
|---|---|
| drdianabilton@cs.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled cross-over trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Primary outcome was lung function as measured by forced expiratory volume in 1 second (FEV1). |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/11/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Cystic Fibrosis and Lung Defence Unit
Cambridge
CB3 8RE
United Kingdom
CB3 8RE
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 | 01/08/2002 | Yes | No | |
| Other publications | HTA monograph | 01/04/2002 | Yes | No |
