ACCURATE: Asthma Control Cost-Utility RAndomized Trial Evaluation
Does exhaled Nitric Oxide improve the aim for asthma control in Primary Care?

despite the availability of effective therapies, asthma remains a source of
significant morbidity and use of health care resources. The central question is
whether maximal doses of (combination) therapy should be used for long periods
in an attempt to achieve complete control of all features of asthma, and
whether patients and society value the potential incremental benefit
sufficiently to concur with such a treatment approach.

The aim of the study is to assess patient preferences and cost-effectiveness of
three treatment strategies aimed at achieving different levels of clinical
control:
1. controlled asthma
2. partly controlled asthma
3. controlled asthma based on exhaled nitric oxide as an additional disease
marker

The design is a cluster-randomised trial with 40 general practices in all three
arms and 12 months follow-up. The patients will visit the general practice at
baseline, 3, 6, 9 and 12 months. At each planned and unplanned visit to the
general practice treatment will be adjusted with support of an ICT-based asthma
monitoring system supervised by a central coordinating specialist nurse.
Patient preferences and utilities will be assessed by questionnaire and
interview. Data on asthma control, treatment step, adherence to treatment,
utilities and costs will be obtained every 3 months and at each unplanned
visit. Differences in societal costs (medication, other (health) care and
productivity) will be compared to differences in the number of limited activity
days and in quality adjusted life years (Dutch EQ5D, SF6D, e-TTO, VAS). The
first year will be used for updating the ICT application in order to
accommodate the treatment algorithms, preparation and writing of program
manuals and internet manuals for distribution to practice nurses,
identification of patients and general practices, and the organisation of
introductory sessions for practice nurses. During the second and third year the
trial will be completed and the second half of the third year will be used for
data analysis and preparation of the manuscripts.

At each planned and unplanned visit to the general practice the treatment step
will be adjusted with support of an ICT-based asthma monitoring system
supervised by a central coordinating specialist nurse.

The treatment recommendations in current national and international guidelines
are largely based on the medical perspective. This hampers the implementation
of these guidelines in a real-life setting and this probably explains the
disappointing adherence of patients to the guidelines. This project is
concerned with the assessment of patients' values and attitudes. This will aid
the process of inclusion of patients* values in asthma guidelines and care.
Treatment options fall within current guidelines. National guidelines advise
3-monthly visits to the general practice including questions on symptoms,
treatment adherence and spirometry [5]. In this study, these visits will be
structured. In addition 3-monthly questionnaires will be assessed by the
patients at home.
The study needs approval by the Medical Ethics Committee of the Leiden
University Medical Center. The subjects will be required to give signed
informed consent (Appendix).