Pharmacological Management of Delirium

Condition(s) targeted: Delirium; Cognitive Impairment

Intervention: Reduced exposure to anticholinergics (Behavioral); Reduced exposure to benzodiazepines (Procedure); Haloperidol (Drug); Usual care (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Regenstrief Institute, Inc.

Official(s) and/or principal investigator(s):
Malaz Boustani, MD, Principal Investigator, Affiliation: Indiana University School of Medicine

Overall contact:
Teresa Smith, BS, Phone: 317-274-9259, Email: smithten@iupui.edu

The purpose of this study is to develop and test the feasibility of using a specific pharmacological protocol to reduce delirium burden among older adults in the Intensive Care Unit (ICU). The study will test the efficacy of a pharmacological intervention in reducing delirium severity and duration as well as length of stay and mortality compared to usual care.

Official title: Pharmacological Management of Delirium

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Delirium severity, days free of delirium and coma, measured by DRS-R-98, CAM-ICU, and RASS

Secondary outcome:

Length of stay

Mortality

Hospital-acquired complications related to delirium or delirium management

Detailed description: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Teresa Smith, BS, Phone: 317-274-9259, Email: smithten@iupui.edu

Eskenazi Hospital, Indianapolis, Indiana 46202, United States; Recruiting
Malaz Boustani, MD, Phone: 317-274-9235, Email: mboustan@iupui.edu
Tiffany Campbell, BS, Phone: 317-274-9052, Email: tiffcamp@iupui.edu
Malaz Boustani, MD, Principal Investigator

Methodist Hospital, Indianapolis, Indiana 46202, United States; Active, not recruiting

University Hospital, Indianapolis, Indiana 46202, United States; Recruiting
Babar A Khan, MD, MS, Phone: 317-274-9132, Email: bakhan@iupui.edu
Tiffany L Campbell, BS, Phone: 317-274-9052, Email: tiffcamp@iupui.edu
Malaz A Boustani, MD, Principal Investigator

Starting date: February 2009
Last updated: August 8, 2014