A randomised controlled
crossover trial of nurse
practitioner versus doctor-
led outpatient care in a
1R&D Unit, Papworth Hospital NHS Trust, Cambridge,UK
2Department of Public Health and Primary Care,
University of Cambridge, Institute of Public Health, Cambridge, UK
3MRC Biostatistics Unit, Institute of Public Health, Cambridge, UK
4Lung Defence Unit, Papworth Hospital NHS Trust, Cambridge, UK
* Corresponding author
Health Technology Assessment
NHS R&D HTA Programme
Health Technology Assessment 2002; Vol. 6: No. 27
Nurse practitioner vs doctor-led outpatient care in a
In the setting of a specialist outpatient clinic for
bronchiectasis patients, the study objectives were:
• to assess the feasibility and safety of nurse
practitioner-led outpatient clinics and their
acceptability to patients and their doctors
• to compare the cost-effectiveness of nurse
practitioner-led care with a doctor-led
system of care.
The study was in two phases. In the first, the nurse
practitioner completed a 6-month training pro-
gramme to enable her to practise independently.
This included tuition in the principles of bronchi-
ectasis and its clinical presentation and manage-
ment, together with practical experience and
skills in clinical assessment and therapeutics.
In the second phase, a randomised controlled
trial of crossover design was used to compare
nurse practitioner-led with doctor-led care in a
bronchiectasis outpatients’ clinic. Sample size
was calculated on the basis of establishing
equivalence of the two modes of care.
The lung defence clinic was introduced at
Papworth Hospital in 1995 as a specialist unit with
the purpose of streamlining the management of
patients with bronchiectasis. Individual manage-
ment plans are developed for intensive treatment
and prophylaxis of endobronchial sepsis. Following
initial investigation, patients with minor disease are
followed-up in their local hospitals, returning to
the specialist clinic annually for review. Patients
with moderate to severe disease are seen in the
specialist clinic several times a year.
It was in this context that the medical team con-
sidered the possibility of expanding the nurse
practitioner’s role to include outpatient follow-up
of bronchiectasis patients. The medical team com-
prised three consultants and one rotating registrar
with 2–3 years’ experience of respiratory medicine.
Bronchiectasis is a chronic, usually progressive,
respiratory disease characterised by dilatation and
thickening of the bronchi. Patients experience
repeated episodes of infection, chronic sputum
production and increasing breathlessness, which
ultimately progress to respiratory failure. The
patients included in the study were over 18 years
of age with moderate or severe bronchiectasis
confirmed by high-resolution computed tomo-
graphy scans. A treatment plan was formulated
before a patient was considered eligible for the
trial. The nurse practitioner did not assess new
Eighty patients were recruited and for the first year
of the study were randomised to receive either
1 year of nurse practitioner-led care or 1 year of
doctor-led care. The two groups then crossed over
to receive the alternate mode of care for a further
year. It was important that patients received each
mode of care for a full year since chronic lung
disease is subject to seasonal variation.
Main outcome measures
The primary outcome measure was lung function
as measured by forced expiratory volume in
1 second (FEV1). Patients were stratified as
stable (decline in FEV1over the preceding
12 months < 5%) or unstable (decline in FEV1
in the preceding 12 months ≥ 5%) prior
Secondary measures included walking distance,
health-related quality of life, nurse practitioner
autonomy, patient and general practitioner satis-
faction with communications and care, patient
compliance with treatment and resource use.
Of the 80 patients recruited, 39 were randomised
to nurse practitioner-led followed by doctor-led
Executive summary: Nurse practitioner vs doctor-led outpatient care in a bronchiectasis clinic
Health Technology Assessment 2002; Vol. 6 No. 27 (Executive summary)
care, and 41 to doctor-led followed by nurse
practitioner-led care. The patients’ mean age at
randomisation was 58 years and 69% of them were
female. Baseline lung function and 12-minute walk
distance were similar in the two groups.
At the final follow-up, the mean difference in FEV1
between nurse practitioner-led and doctor-led care
was 0.2% predicted (95% confidence interval (CI),
–1.6 to 2.0; p = 0.83). The mean difference in 12-
minute-walk distance between the two methods of
service delivery was 18 metres (95% CI, –13 to 48;
p = 0.30). The number of infective exacerbations
experienced by patients during nurse practitioner-
led care was 262 in 79.4 patient-years of follow-up,
compared with 238 in 77.8 years during doctor-led
care. Thus, nurse practitioner-led care resulted in a
relative rate of exacerbation of 1.09; however, the
difference was not statistically significant (95% CI,
0.91 to 1.30; p = 0.34). Of those patients who were
using antibiotics and indicated their compliance,
100% were compliant (95% CI, 89 to 100) while
receiving nurse practitioner-led care compared
with 81% (95% CI, 63 to 93) of patients during
doctor-led care, a difference that was statistically
significant (p = 0.024).
The health-related quality-of-life analysis revealed no
significant mode of care effects. However, patients
reported less vitality/energy and greater levels of
pain following doctor-led care but fewer role
limitations because of emotional problems. In the
analysis of patient satisfaction with the clinic
consultations, there was a statistically significant
difference between the two modes of care, in favour
of the nurse practitioner, in the areas of communi-
cation and time spent with the patient. However,
nurse practitioner-led care resulted in significantly
increased resource use compared with doctor-led
care. The mean difference per patient was £1498
(95% CI, 688 to 2674; p < 0.001) and was greater in
the first year (£2625) than in the second (£411).
Nurse practitioner-led care for stable patients
within a chronic chest disease clinic is safe and
as effective as doctor-led care.
There was significant additional patient satis-
faction with some aspects of nurse practitioner-
led care and better patient compliance with
There was significant additional resource use
related to admissions and antibiotic prescriptions
during nurse practitioner-led care. However, this
may have been a learning curve effect, as the
difference was substantially greater in the first year.
While the treatment and management of the study
patients are broadly generalisable to other chronic
disease clinics, the authors would not recommend
extrapolation of results to acute onset diseases or
diseases in which presentation and/or compli-
cations are wide-ranging or rapidly changing.
The study design – a randomised, controlled,
crossover trial based on equivalence in outcome –
proved robust and appropriate for this type of
evaluation. Randomisation allowed the most
objective treatment assignment over the period
of study and ensured that unpredicted differences
in hospitalisation and cost were detected;
an alternative strategy could have masked
Recommendations for research
Similar evaluations should be considered as part
of the process of introducing nurse practitioner
roles, or any role transfer in the health service,
as much can be learned from the results in
terms of ensuring that their introduction is
both acceptable to patients and cost-effective.
To minimise the learning curve effect in future
studies of this type, randomisation during training
and a formal evaluation of all outcomes immedi-
ately after training would help to identify needs
and to minimise the learning curve effect during
a period of formal evaluation. An alternative
approach would be simply to lengthen the trial.
Caine N, Sharples LD, Hollingworth W, French J,
Keogan M, Exley A, et al. A randomised controlled
crossover trial of nurse practitioner versus doctor-
led outpatient care in a bronchiectasis clinic.
Health Technol Assess 2002;6(27).
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