Design, and participant enrollment, of a randomized controlled trial evaluating effectiveness and cost-effectiveness of a community-based case management intervention, for patients suffering from COPD

Background: Case management interventions are recommended to improve quality of care and reduce costs in chronic care, but further evidence on effectiveness and cost-effectiveness is needed. The objective of this study is the reporting of the design and participant enrollment of a randomized controlled trial, conducted to evaluate the effectiveness and cost-effectiveness of a community-based case management model for patients suffering from chronic obstructive pulmonary disease (COPD). With a focus on support for self-care and care coordination, the intervention was hypothesized to result in a reduced number of COPD-related hospital admissions. Patients and methods: The design was a randomized controlled trial conducted from 2012 to 2014 with randomization and intervention at patient level. The study took place in Aalborg Municipality, a larger municipality in Denmark. A total of 150 COPD patients were randomized into two groups: the case-managed group and the usual-care group. Participant characteristics were obtained at baseline, and measures on effectiveness and costs were obtained through questionnaires and registries within a 12-month follow-up period. In the forthcoming analysis, effectiveness will be evaluated on COPD-related hospital admissions, mortality, health- related quality of life, and self-care. An economic evaluation will examine the cost-effectiveness of case management against current usual care from the perspective of the health care sector. Results: Baseline characteristics were comparable between the two groups except for the prevalence of cancer, which were borderline significantly higher in the case-managed group. This baseline difference will be adjusted for in the final analysis. A very low dropout rate for the intervention was observed, indicating that the intervention was well accepted. Conclusion: Presented in a forthcoming paper, the results of the study will provide new evidence to the future organization of case management. Keywords: personalized care, disease management, health-related quality of life, costeffectiveness analysis