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Research question

In seniors, falls are the leading cause of injuries and often an adverse drug reaction is involved. By lowering drug-related fall risk, loss of QoL, institutionalization and death can be prevented. For optimal drug withdrawal in clinical practice, better understanding and prediction of drug-related fall risk is essential.

Hypothesis

A personalized strategy in older fallers using a clinical decision support system (CDSS) and patient portal will lead to a 45% reduction in risk of injurious falls.

Study design

Development and evaluation of the CDSS/portal will follow the 4 phases of the Medical Research Council guideline for complex interventions. A multi-center RCT (N=856) will be performed.

Study population

New falls clinic patients using FRID in 10 centers with similar electronical medical record system (EMR).

Intervention

Step 1 Preparatory phase: Development of the prediction and explorative models for falls in older persons using fall-risk increasing drugs (FRID). This will be incorporated in the CDSS to generate risk of drug-related falls to individual patients and to an accompanying patient portal. This includes identifying existing theoretical and empirical evidence informing the development of the CDSS/portal; Gathering additional evidence; Testing and adaptation of CDSS/portal prototypes. The CDSS/portal will be implemented in the existing EMR and physicians will be trained. Depending on the performance of the CDSS/portal we will proceed to step 2, the RCT with process evaluation.

Outcome measures

Primary outcome: time to first injurious fall. Secondary outcomes include any fall, no. of falls, QoL, costs.

Samples size/data-analysis

Intervention N=385 and control N=385 (10 clusters with 77 patients in each cluster) are needed to detect a difference in proportion of injurious falls of 0.10 with 80% power. Cox-regression analyses will be used. A process evaluation will be performed among patients and physicians (quantitative analyses and observations).

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