A case management intervention targeted to reduce healthcare consumption for frequent Emergency Department visitors: results from an adaptive randomized trial.

"Conflicts of interest Dr Gustaf Edgren has received consulting fees from Health Navigator AB for providing assistance with study design and research methodology. Joachim Werr is co-owner and managing director of Health Navigator AB. Jacqueline Anderson is an analyst with Health Navigator. Authors Anders Dolk, Jarl Torgerson, Svante Nyberg, Tommy Skau, Birger C Forsberg, and Gunnar Öhlen are county council representatives and therefore members of the funding bodies for this study."

"The authors would like to note the outstanding efforts of the nurses and other medical/nonmedical staff involved in the provision and development of this intervention who made this study possible. The study was jointly financed by the five participating county councils. The funding sources played no direct role in the planning, conduct, or analysis of the study."

"One set of analyses was carried out for the studies following ZD and one for those following a traditional RCT design. All costs were converted into Euros on the basis of current exchange rates. Because we made iterative changes to the intervention, we also stratified the analyses by calendar year of randomization. Tests for homogeneity were performed by fitting interactions between the study group variable and the variables for sex, age, and calendar year of randomization. P-values less than 0.05 were considered statistically significant. All statistical analyses were carried out using SAS Statistical Analysis Software, version 9.4 (Cary, North Carolina, USA). The study was registered at clinicaltrials.org (Nr: NCT01985074)."