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Background  Chronic diseases represent a major challenge for health care and social services. A number of people with chronic diseases require more services due to characteristics that increase their vulnerability. Given the burden of increasingly vulnerable patients on primary care, a pragmatic intervention in four Family Medicine Groups (primary care practices in Quebec, Canada) has been proposed for individuals with chronic diseases (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain) who are frequent users of hospital services. The intervention combines case management by a nurse with group support meetings encouraging self-management based on the Stanford Chronic Disease Self-Management Program. The goals of this study are to: (1) analyze the implementation of the intervention in the participating practices in order to determine how the various contexts have influenced the implementation and the observed effects; (2) evaluate the proximal (self-efficacy, self-management, health habits, activation and psychological distress) and intermediate (empowerment, quality of life and health care use) effects of the intervention on patients; (3) conduct an economic analysis of the efficiency and cost-effectiveness of the intervention.    Methods/Design  The analysis of the implementation will be conducted using realistic evaluation and participatory approaches within four categories of stakeholders (Family Medicine Group and health centre management, Family Medicine Group practitioners, patients and their families, health centre or community partners). The data will be obtained through individual and group interviews, project documentation reviews and by documenting the intervention. Evaluation of the effects on patients will be based on a pragmatic randomized before-after experimental design with a delayed intervention control group (six months). Economic analysis will include cost-effectiveness and cost-benefit analysis.    Discussion  The integration of a case management intervention delivered by nurses and self-management group support into primary care practices has the potential to positively impact patient empowerment and quality of life and hopefully reduce the burden on health care. Decision-makers, managers and health care professionals will be aware of the factors to consider in promoting the implementation of this intervention into other primary care practices in the region and elsewhere.    Trial Registration   NCT01719991

Case management and self-management support for frequent users with chronic disease in primary care: a pragmatic randomized controlled trial