Early pharmacological intervention to prevent delirium: HAlopeRidol PrOphylaxis in Older emergency department patieNts.

INTERVENTION: Trade Name: Haloperidol Product Name: Haloperidol Product Code: RVG 55776 Pharmaceutical Form: Tablet INN or Proposed INN: Haloperidol CAS Number: 52‐86‐8 Current Sponsor code: RVG 55776 Other descriptive name: HALOPERIDOL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Delirium Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: Main Objective: To evaluate the effect of early haloperidol prophylaxis (1mg twice‐daily) on the incidence, severity and duration of in‐hospital delirium in at‐risk patients aged 70 years or over who are admitted to the hospital through the ED, to an acute admission facility, general internal medicine or surgical ward.; Primary end point(s): An absolute reduction of delirium incidence of 10%.; An absolute reduction of delirium duration.; Less severe delirium in haloperidol intervention group. Secondary Objective: To determine:; ‐ mean hospital length of stay (LOS); ; ‐ in‐hospital and 6‐month mortality rate;; ‐ (I)ADL and cognitive (6‐item CIT) function at baseline, and at 3‐ and 6‐months after hospital discharge;; ‐ the need for additional (medical) care after hospital discharge or institutionalization;; ‐ the cost‐effectiveness;; And to additionally describe any differences in the abovementioned secondary objectives between both intervention groups. Timepoint(s) of evaluation of this end point: At 30 days from admission, or sooner when patients is discharged home previously. SECONDARY OUTCOME: Secondary end point(s): A reduction of mean hospital length of stay.; A reduction in 6‐month mortality.; Functionality at baseline and change in functionality at 3‐ and 6 months.; Need for additional (helath)care and/or institutionalisation. Timepoint(s) of evaluation of this end point: At 30 days from admission, or sooner when patients is discharged home previously.; At respectively 90‐ and 180 days from hospital discharge date (time points: 3‐ and 6 months). INCLUSION CRITERIA: ‐ Patients aged 70 years or over; ‐ The patient is at increased risk for developing in‐hospital delirium on admission according to one or more positive answers on the VMS delirium‐risk questions; ‐ The patient or proxy is able to provide written informed consent; ‐ The patient or proxy speaks either Dutch or English; ‐ The patient is admitted to the hospital for an internal or surgical specialty. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 780