Open Access Study protocol

Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial

Johanna L van Gaalen1*, Moira J Bakker1, Leti van Bodegom-Vos1, Jiska B Snoeck-Stroband1, Willem JJ Assendelft2, Ad A Kaptein3, Victor van der Meer1, Christian Taube4, Bart P Thoonen5, Jacob K Sont1 and for the IMPASSE study group

Author Affiliations

1 Department of Medical Decision Making, Leiden University Medical Centre, P.O. Box 9600, 2300, RC, Leiden, the Netherlands

2 Department of Public health and Primary care, Leiden University Medical Centre, P.O. Box, 9600, 2300, RC, Leiden, the Netherlands

3 Department of Medical psychology, Leiden University Medical Centre, P.O. Box, 9600, 2300, RC, Leiden, the Netherlands

4 Department of Pulmonology, Leiden University Medical Centre, P.O. Box, 9600, 2300, RC, Leiden, the Netherlands

5 Department of General Practice, Radboud University Nijmegen Medical Centre, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands

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Implementation Science 2012, 7:113  doi:10.1186/1748-5908-7-113

Published: 21 November 2012

Abstract

Background

Internet-based self-management (IBSM) support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice.

Methods/design

This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS): dissemination of the IBSM program; intermediate strategy (IS): MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals); and extended strategy (ES): IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions) are primarily targeted at general practices, randomisation will occur at practice level.

In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations); self-management related outcomes (health education impact, medication adherence, and illness perceptions); and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption. Follow-up is six months per patient.

Discussion

This study provides insight in the amount of support that is required by general practices for cost-effective implementation of IBSM. Additionally, design and results can be beneficial for implementation of other self-management initiatives in clinical practice.

Trial registration

the Netherlands National Trial Register NTR2970

Keywords:
Asthma; Self-management; Telemanagement; E-health; Self-management; Implementation; Chronic care