A stepped-wedge randomised controlled trial to assess efficacy and cost-effectiveness of a care-bundle to prevent falls in older hospitalised patients.

"Declaration of Conflicts of Interest None. Declaration of Sources of Funding This paper was supported by a grant from the ‘Progetto Regione- Università’, Emilia-Romagna Region (Italy), ‘Research for Clinical Governance’ 2013, for the study: ‘Stepped-Wedge Cluster Randomized Controlled Trial for the Evaluation of Effectiveness of an Accidental Falls Care-Bundle Implementation in Elderly Hospital Patients’. The grant has been assigned to Liliya Chamitava. The Emilia-Romagna Region had no role in the definition of the study design, in the collection, analysis and interpretation of data, in the writing of the report, or in the decision to submit the article for publication."

"Declaration of Sources of Funding This paper was supported by a grant from the ‘Progetto Regione- Università’, Emilia-Romagna Region (Italy), ‘Research for Clinical Governance’ 2013, for the study: ‘Stepped-Wedge Cluster Randomized Controlled Trial for the Evaluation of Effectiveness of an Accidental Falls Care-Bundle Implementation in Elderly Hospital Patients’. The grant has been assigned to Liliya Chamitava. The Emilia-Romagna Region had no role in the definition of the study design, in the collection, analysis and interpretation of data, in the writing of the report, or in the decision to submit the article for publication."

"The study followed the principles of the Declaration of Helsinki and was approved by the Ethical Committee of Bologna University Hospital. The registration number of the study is NCT03147521. Written consent was obtained from patients or their legal representatives for patients with cognitive impairment. Patients could withdraw from the study at any time without negative repercussions on their care. Registration Number: NCT03147521."