Research into prevention of medication induced fall incidents.

Objective/ research questions:

To evaluate the effects and cost-effectiveness of a systematic drug assessment and drug modification in older fallers presenting at the Emergency Department (ED). Based on the results of this study, a clinical protocol will be developed for assessment and modification of drug use among older fallers at the ED.



Study design:

RCT with one intervention and one control group. Older fallers (65+) presenting at the ED, and on 1 or more fall-risk increasing drugs, are eligible. In total 620 patients will be randomized. The intervention group will receive a systematic drug assessment. Fall-risk increasing drugs will be stopped, reduced or substituted by safer drugs where possible. The control group will receive usual care and a systematic drug assessment without drug modification. During 1 year of follow-up, fall incidence, fall-related injuries, medication use, recurrence of (disease)symptoms, and health care consumption (costs) will be registered. Also, patients will complete health-related quality of life questionnaires (SF-12v2 and EQ-5D).



Outcome measures:

Primary outcome parameters will be the incidence of further falls and the possible negative health outcomes of drug withdrawal.

Secondary outcome measures will be fall-related injuries, generic health-related quality of life (HRQOL), compliance and quality adjusted life years.



Data analysis:

The intention-to-treat principle will be followed. The hazard ratio (HR) for falling will be calculated with Cox-regression analyses using the time between the intervention till the first/second fall as the outcome measure.



Economic evaluation:

Cost-effectiveness analysis, including costs per prevented fall as primary outcome measure, and costs per prevented fall-related injury and costs per QALY as secondary outcome measures.

The withdrawal, reduction or substitution of fall-risk increasing drugs will reduce fall risk in the elderly.

- t=0: Baseline fall-related (drug) assessment;

- t=3, 6, 9, 12 months: fall / health questionnaire;

- t=12 months: final fall-related assessment.

Intervention group:

systematic fall-related drugs assessment combined with drug modification.

Control group:

systematic fall-related drug assessment without subsequent drug modification.