Abstract
BackgroundThe diagnosis and treatment of patients with chronic obstructive pulmonary disease (COPD) in Spain continues to present challenges, and problems are exacerbated when there is a lack of coordinated follow-up between levels of care. This paper sets out the protocol for assessing the impact of an integrated management model for the care of patients with COPD. The new model will be evaluated in terms of 1) improvement in the rational utilization of health-care services and 2) benefits reflected in improved health status and quality of life for patients.Methods/DesignA quasi-experimental study of the effectiveness of a COPD management model called COPD PROCESS. The patients in the study cohorts will be residents of neighborhoods served by two referral hospitals in Barcelona, Spain. One area comprises the intervention group (n = 32,248 patients) and the other the control group (n = 32,114 patients). The study will include pre- and post-intervention assessment 18 months after the program goes into effect. Analyses will be on two datasets: clinical and administrative data available for all patients, and clinical assessment information for a cohort of 440 patients sampled randomly from the intervention and control areas. The main endpoints will be the hospitalization rates in the two health-care areas and quality-of-life measures in the two cohorts.DiscussionThe COPD PROCESS model foresees the integrated multidisciplinary management of interventions at different levels of the health-care system through coordinated routine clinical practice. It will put into practice diagnostic and treatment procedures that are based on current evidence, multidisciplinary consensus, and efficient use of available resources. Care pathways in this model are defined in terms of patient characteristics, level of disease severity and the presence or absence of exacerbation. The protocol covers the full range of care from primary prevention to treatment of complex cases.
Highlights
The diagnosis and treatment of patients with chronic obstructive pulmonary disease (COPD) in Spain continues to present challenges, and problems are exacerbated when there is a lack of coordinated follow-up between levels of care
The AUDIPOC project is under way [36]. This multicenter study in 7 Spanish autonomous communities aims to improve the quality and effectiveness of clinical care given to patients with exacerbated COPD; the method is based on nationwide clinical audits and the establishment of guidelines for clinical management of exacerbations
A quasi-experimental design based on comparison of two non-randomized groups was chosen to assess the effectiveness of the multidisciplinary, multicenter COPD PROCESS management model
Summary
The COPD PROCESS evaluation study offers a unique opportunity to learn about the performance of a health management model that is integrated, multidisciplinary, adapted to conditions in Spain and possibly appropriate for countries with similar characteristics. The use of clinical and administrative databases as sources of information places limitations on the comprehensiveness of the analysis and its validity, as the quality of data is dependent on the information storage interface and its adequate and proper use by health-care professionals It was expressly decided, not to create dedicated databases given that the pragmatic nature of the model requires that the information sources be integrated into the daily work routines of the physicians and nurses who are caring for the patients. The fact of implementing the model in a local health-care area may suggest that the results cannot be extrapolated to other settings with different characteristics, the intervention area has no singularly differentiating characteristics and the project will require no investment of resources other than those usually available to any similar health-care system. Possible differences that might emerge between the control and intervention groups will be adjusted by applying multiple regression analysis
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