| QuestionThe central question concerns the decision whether a change in treatment is indicated when asthma is partly controlled (see Appendix Table 1). NB In this proposal we don t include the second question, namely to what extent information on airways inflammation contributes to inform this decision (which was the topic of a recent application for the Netherlands Asthma Foundation). This question is relevant to all patients with asthma who require controller medication on a regular basis. The decision making process is subject to whether more effective treatment options are available (e.g. increased dose or an additional treatment), safety and cost of possible treatment options, the patient s adherence and satisfaction with the level of asthma control. HypothesisA treatment strategy aimed at well controlled asthma is more (cost-)effective as compared to a treatment strategy aimed at achieving partly controlled asthma.ObjectiveTo assess patient preferences and cost-effectiveness of three treatment strategies aimed at achieving different levels of clinical asthma control (See Appendix Table 1): 1. partly controlled asthma (PC-strategy) (included in ZON-MW application)2. well controlled asthma (WC-strategy) (included in ZON-MW application)The levels of control are defined according to recent national and the 2006 update of international guidelines (nhg.artsennet.nl, www.ginasthma.org (6)) (see Appendix Table 1). 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 two recommended strategies (www.ginasthma.org) aimed at achieving different levels of clinical control: 1. partly controlled asthma 2. well controlled asthma 480 patients with mild to moderate persistent asthma from 80 general practices with a nurse practitioner or physician assistant, age 18-50 yr, treatment step 2-4, will be identified via primary care patient registries in the Leiden and Nijmegen areas. The design is a cluster-randomised trial with 40 general practices in both arms and 12 months follow-up. The patients will visit the general practice at baseline, 3, 6, and 12 months. 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 nurse specialist. Patient 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 programme manuals and internet manuals for distribution to nurse practitioners or physician assistants, identification of patients and general practices, organisation of introductory sessions for nurse practitioners or physician assistants. 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. |
