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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG034205 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haloperidol Eligible Intervention | Experimental | 0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines |
|
| Haloperidol Eligible Usual Care | Active Comparator | Usual care |
|
| Haldol-Ineligible Arm | Experimental | 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 |
|
| Haldol Ineligible Usual Care | Active Comparator | Usual Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced exposure to anticholinergics | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Days Free of Delirium and Coma | Admission through day 8 of stay |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay Post Randomization | Participants were followed for the duration of hospital stay, an average of 11 days | |
| Mortality | ICU, in-hospital, 30-days post hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malaz Boustani, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Methodist Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37589315 | Derived | Wang S, Perkins AJ, Chi R, Yates BA, Khan SH, Gao S, Boustani M, Khan BA. Risk factors for dementia in older intensive care unit (ICU) survivors. Alzheimers Dement. 2024 Jan;20(1):278-287. doi: 10.1002/alz.13423. Epub 2023 Aug 17. | |
| 36002562 | Derived | Ortiz D, Lindroth HL, Braly T, Perkins AJ, Mohanty S, Meagher AD, Khan SH, Boustani MA, Khan BA. Delirium severity does not differ between medical and surgical intensive care units after adjusting for medication use. Sci Rep. 2022 Aug 24;12(1):14447. doi: 10.1038/s41598-022-18429-9. |
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551 patients were consented into the study. After completing the consent and randomization, 6 patients withdrew from the study and were included in intention-to-treat analysis. 545 patients completed the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Haloperidol Eligible Intervention | 0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines 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 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 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 |
| FG001 | Haloperidol Eligible Usual Care | Usual care Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium |
| FG002 | 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 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 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 |
| FG003 | Haldol Ineligible Usual Care | Usual Care Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Haloperidol Eligible Intervention | 0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines 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 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 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Days Free of Delirium and Coma | Posted | Median | Inter-Quartile Range | days | Admission through day 8 of stay |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Haloperidol Eligible Intervention | 0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines 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 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 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patients with CNS | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Events | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Malaz Boustani | Regenstrief Institute, Inc. | (317) 274-9235 | mboustan@iu.edu |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D060825 | Cognitive Dysfunction |
| D003221 | Confusion |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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|
| Reduced exposure to benzodiazepines | Procedure | 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 |
|
| Haloperidol | Drug | 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 |
|
|
| Usual care | Procedure | May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium |
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| University Hospital | Indianapolis | Indiana | 46202 | United States |
| 32383964 | Derived | Lindroth H, Khan BA, Carpenter JS, Gao S, Perkins AJ, Khan SH, Wang S, Jones RN, Boustani MA. Delirium Severity Trajectories and Outcomes in ICU Patients. Defining a Dynamic Symptom Phenotype. Ann Am Thorac Soc. 2020 Sep;17(9):1094-1103. doi: 10.1513/AnnalsATS.201910-764OC. |
| 30681720 | Derived | Khan BA, Perkins AJ, Campbell NL, Gao S, Farber MO, Wang S, Khan SH, Zarzaur BL, Boustani MA. Pharmacological Management of Delirium in the Intensive Care Unit: A Randomized Pragmatic Clinical Trial. J Am Geriatr Soc. 2019 May;67(5):1057-1065. doi: 10.1111/jgs.15781. Epub 2019 Jan 25. |
| 21645330 | Derived | Campbell NL, Khan BA, Farber M, Campbell T, Perkins AJ, Hui SL, Abernathy G, Buckley J, Sing R, Tricker J, Zawahiri M, Boustani MA. Improving delirium care in the intensive care unit: the design of a pragmatic study. Trials. 2011 Jun 6;12:139. doi: 10.1186/1745-6215-12-139. |
| BG001 | Haloperidol Eligible Usual Care | Usual care Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium |
| BG002 | 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 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 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 |
| BG003 | Haldol Ineligible Usual Care | Usual Care Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Haloperidol Eligible Usual Care | Usual care Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium |
| OG002 | 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 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 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 |
| OG003 | Haldol Ineligible Usual Care | Usual Care Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium |
|
|
| Secondary | Hospital Length of Stay Post Randomization | Posted | Mean | Standard Deviation | days | Participants were followed for the duration of hospital stay, an average of 11 days |
|
|
|
| Secondary | Mortality | Posted | Count of Participants | Participants | ICU, in-hospital, 30-days post hospitalization |
|
|
|
| 45 |
| 174 |
| 87 |
| 174 |
| EG001 | Haloperidol Eligible Usual Care | Usual care Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium | 57 | 177 | 82 | 177 |
| EG002 | 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 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 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 | 27 | 99 | 63 | 99 |
| EG003 | Haldol Ineligible Usual Care | Usual Care Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium | 22 | 101 | 59 | 101 |
| Patients with Cardiovascular | Cardiac disorders |
|
| Patients with Respiratory | Respiratory, thoracic and mediastinal disorders |
|
| Patients with GI | Gastrointestinal disorders |
|
| Patients with GU | Renal and urinary disorders |
|
| Patients with Skin | Skin and subcutaneous tissue disorders |
|
| Patients with Hepatic | Hepatobiliary disorders |
|
| Patients with Hematologic | Blood and lymphatic system disorders |
|
| Patients with Endocrine | Endocrine disorders |
|
| Patients with Musculoskeletal | Musculoskeletal and connective tissue disorders |
|
| Other | Investigations |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |