• Bert Leysen, Bart Van den Eynden, Birgit Gielen, Hilde Bastiaens, and Johan Wens.
• Department of Primary and Interdisciplinary Care, University of Antwerp, Universiteitsplein 1, Antwerp, Wilrijk, 2610, Belgium. bert.leysen@uantwerpen.be.
• BMC Palliat Care. 2015 Sep 28; 14: 46.

BackgroundStarting with early identification of palliative care patients by general practitioners (GPs), the Care Pathway for Primary Palliative Care (CPPPC) is believed to help primary health care workers to deliver patient- and family-centered care in the last year of life. The care pathway has been pilot-tested, and will now be implemented in 5 Belgian regions: 2 Dutch-speaking regions, 2 French-speaking regions and the bilingual capital region of Brussels. The overall aim of the CPPPC is to provide better quality of primary palliative care, and in the end to reduce the hospital death rate. The aim of this article is to describe the quantitative design and innovative data collection strategy used in the evaluation of this complex intervention.Methods/DesignA quasi-experimental stepped wedge cluster design is set up with the 5 regions being 5 non-randomized clusters. The primary outcome is reduced hospital death rate per GPs' patient population. Secondary outcomes are increased death at home and health care consumption patterns suggesting high quality palliative care. Per research cluster, GPs will be recruited via convenience sampling. These GPs -volunteering to be involved will recruit people with reduced life expectancy and their informal care givers. Health care consumption data in the last year of life, available for all deceased people having lived in the research clusters in the study period, will be used for comparison between patient populations of participating GPs and patient populations of non-participating GPs. Description of baseline characteristics of participating GPs and patients and monitoring of the level of involvement by GPs, patients and informal care givers will happen through regular, privacy-secured web-surveys. Web-survey data and health consumption data are linked in a secure way, respecting Belgian privacy laws.DiscussionTo evaluate this complex intervention, a quasi-experimental stepped wedge cluster design has been set up. Context characteristics and involvement level of participants are important parameters in evaluating complex interventions. It is possible to securely link survey data with health consumption data. By appealing to IT solutions we hope to be able to partly reduce respondent burden, a known problem in palliative care research.Trial RegistrationClinicalTrials.gov Identifier: NCT02266069.

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