Pharmacological Management of Delirium

In 2005, approximately 2.7 million Americans aged 65 and older spent at least one day in the
intensive care unit (ICU), costing Medicare an estimated $27.5 billion. It is estimated that
while hospitalized, up to 80% of these older ICU patients had delirium, an acute brain
failure that is an independent predictor of morbidity and mortality which often goes
unrecognized. Older adults with delirium are more prone to falls, injuries, pressure ulcers
and restraints, complications which may also contribute to prolonged ICU and hospital length
of stay, higher mortality rates, poorer functional status, limited rehabilitation, increased
institutionalization, and higher health care costs. The literature supports treatment with a
combination of a reduction in the use of benzodiazepines and anticholinergics and the use of
low-dose neuroleptics such as haloperidol. However, there have been no randomized controlled
trials evaluating the efficacy of this approach on reducing delirium severity, duration, and
complications.

Building upon the e-CHAMP study, ("Enhancing Care for Hospitalized Older Adults With Memory
Problems;" see NCT00182832), a recently completed quality improvement project tested the
effectiveness of cognitive screening coupled with computerized decision support in reducing
delirium and other hospital-related complications among 424 older adults hospitalized on the
medical wards, which found that many of the older adults entering the study had already
experienced delirium in the ICU prior to their transfer to the wards. This study will test a
pharmacologic intervention that allows a more targeted approach to the care of older adults
with delirium while still recognizing the clinicians' role in controlling symptoms and
providing intensive care.

The hypothesis is that patients in the intervention arm as compared to usual care will have:

- reduced delirium severity, as measured by the Delirium Rating Scale (DRS-R-98), at one
week following randomization or hospital discharge

- fewer hospital days with delirium or coma as determined by the Confusion Assessment
Method in the ICU (CAM-ICU)

- shorter hospital lengths of stay

- lower ICU, hospital, and 30-day mortality

Inclusion Criteria:

- 18 years of age or older

- Hospitalized on an ICU ward

- Delirium based on the RASS and the CAM-ICU assessments at any day during ICU stay

- English speaking

Exclusion Criteria:

- Admitted directly to a regular non-ICU ward

- Previously enrolled in the study

- Not eligible for delirium assessment as determined by RASS scores

- Prior history of severe mental illness

- Alcohol-related delirium

- Pregnant or nursing

- Have had an aphasic stroke