Samenvatting van de aanvraag

Dit item is dichtgeklapt
Dit item is opengeklapt

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.


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).


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).

Naar boven
Direct naar: InhoudDirect naar: NavigatieDirect naar: Onderkant website