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

Sabrina Storgaard Sørensen,1 Kjeld Møller Pedersen,1 Ulla Møller Weinreich,2,3 Lars Holger Ehlers,1 1Danish Center for Healthcare Improvements, Faculty of Social Sciences and Faculty of Health Sciences, Aalborg University, Aalborg East, Denmark; 2Department of Respiratory Medicine, Aalborg University Hospital, Aalborg, Denmark; 3The Clinical Institute, Aalborg University Hospital, Aalborg, Denmark 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, cost-effectiveness analysi