Stanford PIPRA Validation Study in an Elderly Orthopedic Population
NCT Number: NCT06567574
Acronym: PIPRA-ORTHO
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Delirium|Postoperative Delirium|Cognitive Impairment
Sponsor: Stanford University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-30
Completion Date: 2024-06-30
Locations: Stanford Medical Center, Palo Alto, California, 94304, United States

Summary:
The purpose of this study is to determine the accuracy of an AI-based tool in the prediction of postoperative delirium (POD), in a population at moderately high risk of developing this syndrome (i.e., elderly orthopedic subjects). The population to be studied has already been enrolled in a parallel study regarding the likelihood of developing delirium, its relationship to the type of anesthetic, and the relationship between anesthetic type, development of delirium and risk for post-operative cognitive impairment (including risk for dementia) (Protocol ID#55169 \[David Drover-Principal investigator; José Maldonado-Co-investigator\]).

Primary Outcome Measures: Number of subjects with postoperative delirium accurately predicted by the PIPRA Tool, Assessment of the accuracy on the prediction of subjects identified as developing delirium by the PIPRA tool, as compared with post-operative standardized delirium assessment tools. We will compare the assessment of the PIPRA prediction tool (performed pre-op) with the actual development of delirium as assessed by a clinical assessment based on DSM; the CAM-ICU \& SPTD assessment tools., Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively|Development of post-operative Delirium, Number of subjects diagnosed with post-operative delirium, Up to 72 hours post-operatively|Determination of Delirium Phenotype, For those who develop delirium, the phenotype of delirium will be determined as per the Liptzin-Levkoff Criteria (based on DSM diagnostic Criteria). As such, all delirium episodes will be categorized as: hyperactive, hypoactive, mixed, or subsyndromal delirium., Up to 72 hours post-operatively.|Impact of delirium on post-operative cognitive impairment, Impact of delirium occurrence and emergence of cognitive impairment post-operatively, Up to 10-year post-operatively.|Sensitivity and specificity of the PIPRA tool for detecting postoperative delirium., Sensitivity and specificity of various cut off points of the PIPRA tool for detecting postoperative delirium., Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively|Receiver operating characteristic (ROC) curve analysis of PIPRA tool, Receiver operating characteristic (ROC) curve analysis of PIPRA tool, Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively
Secondary Outcome Measures: Immediate Postoperative Mortality, Mortality rate immediately after index surgery, From date of post-operative admission up to time of postoperative discharge, an average of 72 hours.|Length of Hospital Length of Stay, Total number of days admitted to the hospital, From date of post-operative admission up to time of postoperative discharge (assessed up to 1 year after admission).|Discharge Site, Site of discharge (e.g., home, rehabilitation, skilled nurse facility, etc), Type of facility the patient was discharge to from the hospital (assessed up to 6 months from admission)|Requirement of Intensive Care Unit Admission, Need for admission to an intensive care unit due to clinical necessity or deterioration, Time to discharge from the hospital (assessed up to 6 months from admission)|Need of pharmacological protocol, Need of pharmacological protocol for management of delirium, From post-operative hospital admission up to time of postoperative discharge (assessed up to 6 months from admission)