Pharmacological Management of Delirium (PMD)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Methodist Hospital
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Indianapolis, Indiana, Estados Unidos, 46202
- University Hospital
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Indianapolis, Indiana, Estados Unidos, 46202
- Eskenazi Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Haloperidol Eligible Intervention
0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
|
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
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
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
Otros nombres:
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|
Comparador activo: Haloperidol Eligible Usual Care
Usual care
|
May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
|
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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 |
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
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
|
|
Comparador activo: Haldol Ineligible Usual Care
Usual Care
|
May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Days Free of Delirium and Coma
Periodo de tiempo: Admission through day 8 of stay
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Admission through day 8 of stay
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Hospital Length of Stay Post Randomization
Periodo de tiempo: Participants were followed for the duration of hospital stay, an average of 11 days
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Participants were followed for the duration of hospital stay, an average of 11 days
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Mortality
Periodo de tiempo: ICU, in-hospital, 30-days post hospitalization
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ICU, in-hospital, 30-days post hospitalization
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Malaz Boustani, MD, Indiana University School of Medicine
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades del Sistema Nervioso
- Manifestaciones neurológicas
- Confusión
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Delirio
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes colinérgicos
- Antieméticos
- Agentes Gastrointestinales
- Agentes antipsicóticos
- Agentes tranquilizantes
- Drogas psicotropicas
- Agentes de dopamina
- Antagonistas de la dopamina
- Agentes contra la discinesia
- Haloperidol
- Decanoato de haloperidol
- Antagonistas colinérgicos
Otros números de identificación del estudio
- IA0145
- R01AG034205 (Subvención/contrato del NIH de EE. UU.)
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