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Pharmacological Management of Delirium (PMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00842608
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : March 24, 2017
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
MALAZ BOUSTANI, Regenstrief Institute, Inc.

Tracking Information
First Submitted Date  ICMJE February 10, 2009
First Posted Date  ICMJE February 12, 2009
Results First Submitted Date  ICMJE November 11, 2016
Results First Posted Date  ICMJE March 24, 2017
Last Update Posted Date August 17, 2018
Study Start Date  ICMJE February 2009
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
Days Free of Delirium and Coma [ Time Frame: Admission through day 8 of stay ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
Delirium severity, days free of delirium and coma, measured by DRS-R-98, CAM-ICU, and RASS [ Time Frame: Daily ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
  • Hospital Length of Stay Post Randomization [ Time Frame: Participants were followed for the duration of hospital stay, an average of 11 days ]
  • Mortality [ Time Frame: ICU, in-hospital, 30-days post hospitalization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
  • Length of stay [ Time Frame: end of ICU stay and hospital stay ]
  • Mortality [ Time Frame: ICU, in-hospital, 30-days post hospitalization ]
  • Hospital-acquired complications related to delirium or delirium management [ Time Frame: Daily ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacological Management of Delirium
Official Title  ICMJE Pharmacological Management of Delirium
Brief Summary 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Delirium
  • Cognitive Impairment
Intervention  ICMJE
  • Behavioral: Reduced exposure to anticholinergics

    Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.

    Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol

  • Procedure: Reduced exposure to benzodiazepines
    Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
  • Drug: Haloperidol
    0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital
    Other Name: Haldol
  • Procedure: Usual care
    May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
Study Arms  ICMJE
  • Experimental: Haloperidol Eligible Intervention
    0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
    Interventions:
    • Behavioral: Reduced exposure to anticholinergics
    • Procedure: Reduced exposure to benzodiazepines
    • Drug: Haloperidol
  • Active Comparator: Haloperidol Eligible Usual Care
    Usual care
    Intervention: Procedure: Usual care
  • Experimental: Haldol-Ineligible Arm

    Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.

    Patients are randomized and will still receive:

    reduced exposure to anticholinergics, reduced exposure to benzodiazepines

    Interventions:
    • Behavioral: Reduced exposure to anticholinergics
    • Procedure: Reduced exposure to benzodiazepines
  • Active Comparator: Haldol Ineligible Usual Care
    Usual Care
    Intervention: Procedure: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2015)
551
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2009)
428
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00842608
Other Study ID Numbers  ICMJE IA0145
R01AG034205 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MALAZ BOUSTANI, Regenstrief Institute, Inc.
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Malaz Boustani, MD Indiana University School of Medicine
PRS Account Indiana University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP