Haloperidol prophylaxis in older emergency department patients.

Delirium is a severe neuropsychiatric disorder occurring frequently in the acutely admitted, older patient. Hospital prevalence numbers range from 8.6% to 52% in patients aged 65 years or over. Older patients who develop delirium are at risk of developing a range of negative outcomes such as increased hospital length of stay (LOS), high morbidity and mortality, cognitive and functional decline and increased institutionalisation after hospital discharge. As a result of these (long-term) negative health outcomes, delirium is associated with increased (non-) healthcare costs. Due to expected increase in the elderly population, this will be an even more significant health-problem in the near future. What causes delirium is usually multi-factorial, which makes delirium management very difficult. In order to prevent delirium, intervention strategies targeting reversible risk factors have been developed. Implementing these measures reduces the incidence of delirium, but not the delirium severity and duration. There may to be a promising role for prophylactic use of a low dose (≤ 2.0mg/24 hours) of the typical antipsychotic drug haloperidol: currently the drug-of-choice in the treatment of delirium once it develops. In selected patients undergoing (elective) hip surgery, prophylactic treatment with low-dose haloperidol (1.5 ¨C 2.0mg/24 hours) in older at-risk patients seems to reduce severity and duration of delirium, though its effect on delirium incidence is non-significant. However, these results are hardly generalizable due to study population and study-size. Further research on the effectiveness of additive early haloperidol prophylaxis in the prevention of delirium in acutely admitted older patients is needed. Given its multifactorial origin and the fact that haloperidol is still the drug of choice in the symptomatic treatment of delirium, consistent with current guidelines though evidence is lacking, we propose a double-blind, randomized, placebo controlled trial to evaluate the efficacy of prophylactic low-dose haloperidol (1.0mg twice-daily), rather than antipsychotics, benzodiazepines or melatonin, on delirium prevention in an older at-risk general patient population. The risk of developing delirium during hospital admission will be determined according to criteria mentioned in the Dutch ¡®Safety Management System (VMS) (www.vmszorg.nl).

We hypothesize that addition of low-dose haloperidol prophylaxis (1.0mg twice-daily) on top of the existing standard of care reduces in-hospital delirium incidence, severity and duration in a general patient population, age 70 years or over, who are acutely admitted to the hospital through the emergency department (ED) and who are at-risk for delirium on admission.

1. Baseline;

2. 3 and 6 months after discharge.

Each subject will be randomly assigned to prophylactic treatment with either haloperidol or placebo for 7 days, starting the day of hospital admission. Dosage schedule: 1 mg twice-daily at 12am and 8 pm.