Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)

Completed

• Conditions: Delirium; Cognitive Impairment

• Registration Number: NCT02481115
• Lead Sponsor: Vanderbilt University

Brief Summary

The investigators hypothesize that critical care trained registered nurses and physicians can perform measurements of cognitive impairment in critically ill pediatric patients in a reliable and valid manner. To test this hypothesis, the investigators will incorporate an instrument (psCAM-ICU) to assess both components of consciousness, arousal and content, in critically ill pediatric patients at least 6 months to children 5 years of age, both on and off mechanical ventilation, and compare these assessments to those of the reference standard.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-25
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• All patients admitted to the Pediatric Critical Care Unit regardless of admitting diagnosis aged at least 6 months of age up to 5 years of age.
• Patients ventilated or non-ventilated.

Exclusion Criteria

• Non-English speaking patients.
• Children with visual or hearing impairments.
• Patient/surrogate or physician refusal
• Moribund and not expected to survive >48 hours
• Patients in whom comfort care orders have been instituted
• Patients who are identified for transfer to floor or home regardless of placed orders or bed availability

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of psCAM-ICU	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	The investigators will validate the psCAM-ICU against a reference standard delirium assessment in critically ill infants and young children. Critical care physicians and registered nurses will use the psCAM-ICU to determine presence or absence of delirium once daily in critically ill infants and young children from 6 months to less than 5 years of age. The reference standard, a pediatric delirium expert (child psychiatrist or equivalent), will independently evaluate the same patients for presence or absence of delirium using the Diagnostic and Statistical Manual of Mental Disorders (DSM IV-TR) as the foundation of assessment.

Secondary Outcome Measures

Name	Time	Method
Inter-rater reliability of diagnosing delirium	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	The investigators will assess inter-rater reliability between physician, practitioner, and nursing assessment using the psCAM-ICU. The psCAM-ICU should consistently diagnose delirium in the critically ill pediatric patient, independent of the type of medical care provider assessing the patient.
Validation of the Richmond Agitation Sedation Scale (RASS)	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	The investigators will validate the RASS against the Glasgow Coma Scale in critically ill infants and young children less than 5 years of age.
Validation of the Withdrawal Assessment Tool-1 (WAT-1)	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	The investigators will validate the WAT-1 against a reference standard (child psychiatrist) in critically ill infants and young children less than 5 years of age.
Long-term cognitive impairment composite	1 year	Clinical data will be obtained from the medical record to determine a composite measure of long-term cognitive impairment. The composite will include specific outcomes, and follow-up phone interviews with be conducted with a parent/legal guardian at 12 months post-hospital discharge of enrolled patients to assess cognitive function using a validated questionnaire that is compared to expected developmental trajectories based on age adjusted norms.