Towards better asthma care for children: protocolled practice nurse-led care for children 6-12 years in primary care. A randomized controlled trial.

Daily symptoms and exacerbations in children with asthma have significant
impact on the quality of life of both the children and the parents. More
effective use of asthma medication is advocated, since over- and undertreatment
is reported in primary care. Protocolled care by the General Practitioner (GP)
may lead to better asthma treatment in children. There is already a guideline
to support this asthma care (*Zorgstandaard*). This guideline recommends
planned reconsultations with structured evaluations of individual care-plans
and gained goals, making it possible to make alterations in the management of
the child*s asthma more proactively. However, this protocolled care by the GP
may be time-consuming and therefore less feasible. Protocolled care in general
practice supplied by a practice nurse, and under supervision of the GP, may
give similar (or even better) improvements in asthma care for children. For
diabetes mellitus in primary care it is sufficiently proved that management can
be safely transferred to practice nurses. With regard to asthma, a recent
systematic review found no significant difference between hospital based
nurse-led care for patients with asthma compared to physician-led care.15
However, the relatively small number of included studies limited this review
and further research was advised. Besides, only 2 relatively small studies of
the in total 5 included studies concerned asthma in children and both of these
studies evaluated care by hospital-based specialized asthma nurses and
therefore extrapolation of results to primary care is insufficiently supported.

The academic network of GPs *PrimEUR* in Rotterdam and the South-West of the
Netherlands consists of 12 GP health centers. In addition another 14 GP
practices will be recruited. All eligible children aged 6 to 12 years old in
the participating GP practices will be invited to participate. Eligible
patients will be selected by searching the electronic patient database of GPs
for patients who were prescribed one or more ICS, and/or 2 or more
prescriptions of salbutamol or terbutaline in the last year. Children with only
one prescription of salbutamol or terbutaline and a registered ICPC-code
(International Classification of Primary Care code) for asthma (R96) or
'Prikkelbare luchtwegen' (R29.02) are also eligible for inclusion.

To answer the research questions, we want to conduct a cluster- open label
randomized controlled trial with a follow-up of 18 months.

The participating practices with their practice nurse, will be randomized to
one of the following treatment arms:
1. Protocolled practice nurse-led asthma care according to the Zorgstandaard18
and the GP- guideline of the NHG of asthma in children.9 Participating
practice nurses will receive an up-to-date retraining in protocolled asthma
care for children. See chapter *burden* for the recommended follow-up schedule.
2. Usual (GP-led) care.

Besides the randomised part of this trial, we will conduct a non-randomised
part of the trial. In this case, children who will receive protocolled
nurse-led care by a practice nurse will be selected by the same inclusion and
exclusion criteria of the other children in the trial. We will conduct
indentical measurements in these children (quuestionnaires and spirometry)

Questionnaires and spirometry tests (for more details, see other paragraphs)

Nurse-led care has been proven to be safe in other chronic conditions such as
diabetes mellitus in adults. No invasive measurements are conducted. In this
study, we will conduct two spirometry tests, which, in the opinion of the
authors, will cause no additional harm to the children. The implementation of
protocolled asthma care for children in primary care may result in a better
control of asthma symptoms, may reduce over- an under treatment and
misclassification in children. Thus if children get a more efficient treatment
for their asthma, they will be less limited in school, sports and daily life.
Therefore, the participation of children and the parents is essential for this
research.

In the current study, we will conduct two spirometry tests. Reversibility of
the FEV1 and the FEF 75 will be tested by administering Salbutamol (inhalation
medication).Side effects could occur, however, these symptoms usually only
occur when salbutamol is used in higher dosage. In current trial, we will not
exceed the maximum dosage. We request the parents of the child to stop
bronchodilators before the test. This could lead to a temporarily increase of
the symptoms of asthma. However, this is a standard procedure for spirometry
and, of course, when it is not possible or medically irresponsible to stop the
inhalation medication at that moment we will postpone spirometry.