DeliriumPIPRA-ORTHONCT06567574
Stanford PIPRA Validation Study in an Elderly Orthopedic Population
An observational study of Delirium and Postoperative Delirium, run by Stanford University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Postoperative Delirium, Cognitive Impairment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Stanford Hospital geriatric patients having surgery
Who may be able to join
- Surgical patients
- Greater than or equal to 65 years old
- ASA I, II or III
- Greater than 90 min of surgery
- Non-cardiac surgery
Who cannot join
- Dementia
- Alzheimer's
- Parkinson's
- Current Benzodiazepine use
- Alcoholism
- Previous surgery within the last 12 months or expected in the 12 months to come (except the expected surgery for which they are being enrolled).
- Color-blindness
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Medical Center
Palo Alto, California, 94304
About this study
Official title: Stanford Study of the Validation of the Pre-Interventional Preventive Risk Assessment (PIPRA) Tool In The At-Risk Orthopedic Surgery Population
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]).
Read the detailed description
Study investigators would like to determine the real-life accuracy of a new tool developed for the prediction of delirium: Pre-Interventional Preventive Risk Assessment (PIPRA) Tool. The importance of assessing the risk for post-operative delirium (POD) includes: providing clinicians and patients with accurate predictive information regarding the patient's risk for developing delirium as part of the risk/benefit calculation for surgical procedures, and thus potential risk of subsequent cognitive impairment; as well as the ability to introduce timely prophylactic techniques that may prevent its onset.
The PIPRA tools consists of nine items commonly found in any presurgical patient's electronic medical record (EMR). The tool has been designed to run in the background of the EMR and automatically calculate the patient's risk for developing delirium upon admission for surgical intervention. For our study, we will be applying the PIPRA tool to the EMR of patients already enrolled in a parallel study as detailed above.
The PIPRA tool predicts the risk of developing POD delirium based on its algorithm that takes into consideration the following nine clinical variables: age, height/weight or body mass index, the American Society of Anesthesiologist physical status Classification system (ASA), past history of delirium, past history of cognitive impairment (including dementia), number of medications, preoperative C-reactive protein levels, surgical risk (as determined by the European Society of Anesthesiology), and type of surgery. The subsequent result predicts the risk (in percentage) of a patient developing POD following surgery.
The PIPRA tool is fully integrated into EMR systems, operating in the background, extracting relevant information, and automatically generating a delirium prediction score. In addition, this software possesses the flexibility to recalibrate the delirium risk based on the availability of the nine clinical variables.
- Conditions
- Delirium, Postoperative Delirium, Cognitive Impairment
- Keywords
- Artificial Intelligence, Delirium Risk Factors, Delirium, Postoperative Delirium, Cognitive Impairment
- Medical subject headings
- Delirium, Emergence Delirium, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively
Secondary outcomes (5)
Immediate Postoperative Mortality
Mortality rate immediately after index surgery
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: From post-operative hospital admission up to time of postoperative discharge (assessed up to 6 months from admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start30 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose R Maldonado, MD, Stanford University
- Investigators
- José R Maldonado, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567574
- Sponsor's protocol ID
- IRB-73341
- Acronym
- PIPRA-ORTHO
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buchan TA, Sadeghirad B, Schmutz N, Goettel N, Foroutan F, Couban R, Mbuagbaw L, Dodsworth BT. Preoperative prognostic factors associated with postoperative delirium in older people undergoing surgery: protocol for a systematic review and individual patient data meta-analysis. Syst Rev. 2020 Nov 14;9(1):261. doi: 10.1186/s13643-020-01518-z.
PubMed 33189147Dodsworth BT, Reeve K, Falco L, Hueting T, Sadeghirad B, Mbuagbaw L, Goettel N, Schmutz Gelsomino N. Development and validation of an international preoperative risk assessment model for postoperative delirium. Age Ageing. 2023 Jun 1;52(6):afad086. doi: 10.1093/ageing/afad086.
PubMed 37290122Sadeghirad B, Dodsworth BT, Schmutz Gelsomino N, Goettel N, Spence J, Buchan TA, Crandon HN, Baneshi MR, Pol RA, Brattinga B, Park UJ, Terashima M, Banning LBD, Van Leeuwen BL, Neerland BE, Chuan A, Martinez FT, Van Vugt JLA, Rampersaud YR, Hatakeyama S, Di Stasio E, Milisen K, Van Grootven B, van der Laan L, Thomson Mangnall L, Goodlin SJ, Lungeanu D, Denhaerynck K, Dhakharia V, Sampson EL, Zywiel MG, Falco L, Nguyen AV, Moss SJ, Krewulak KD, Jaworska N, Plotnikoff K, Kotteduwa-Jayawarden S, Sandarage R, Busse JW, Mbuagbaw L. Perioperative Factors Associated With Postoperative Delirium in Patients Undergoing Noncardiac Surgery: An Individual Patient Data Meta-Analysis. JAMA Netw Open. 2023 Oct 2;6(10):e2337239. doi: 10.1001/jamanetworkopen.2023.37239.
PubMed 37819663Maldonado JR. Acute Brain Failure: Pathophysiology, Diagnosis, Management, and Sequelae of Delirium. Crit Care Clin. 2017 Jul;33(3):461-519. doi: 10.1016/j.ccc.2017.03.013.
PubMed 28601132Robinson TN, Eiseman B. Postoperative delirium in the elderly: diagnosis and management. Clin Interv Aging. 2008;3(2):351-5. doi: 10.2147/cia.s2759.
PubMed 18686756
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford Study of the Validation of the Pre-Interventional Preventive Risk Assessment (PIPRA) Tool In The At-Risk Orthopedic Surgery Population
- ClinicalTrials.gov ID
- NCT06567574
- Acronym / sponsor ID
- PIPRA-ORTHO / IRB-73341
- Conditions
- Delirium, Postoperative Delirium, Cognitive Impairment
- Keywords
- Artificial Intelligence, Delirium Risk Factors, Delirium, Postoperative Delirium, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Detailed description
Study investigators would like to determine the real-life accuracy of a new tool developed for the prediction of delirium: Pre-Interventional Preventive Risk Assessment (PIPRA) Tool. The importance of assessing the risk for post-operative delirium (POD) includes: providing clinicians and patients with accurate predictive information regarding the patient's risk for developing delirium as part of the risk/benefit calculation for surgical procedures, and thus potential risk of subsequent cognitive impairment; as well as the ability to introduce timely prophylactic techniques that may prevent its onset.
The PIPRA tools consists of nine items commonly found in any presurgical patient's electronic medical record (EMR). The tool has been designed to run in the background of the EMR and automatically calculate the patient's risk for developing delirium upon admission for surgical intervention. For our study, we will be applying the PIPRA tool to the EMR of patients already enrolled in a parallel study as detailed above.
The PIPRA tool predicts the risk of developing POD delirium based on its algorithm that takes into consideration the following nine clinical variables: age, height/weight or body mass index, the American Society of Anesthesiologist physical status Classification system (ASA), past history of delirium, past history of cognitive impairment (including dementia), number of medications, preoperative C-reactive protein levels, surgical risk (as determined by the European Society of Anesthesiology), and type of surgery. The subsequent result predicts the risk (in percentage) of a patient developing POD following surgery.
The PIPRA tool is fully integrated into EMR systems, operating in the background, extracting relevant information, and automatically generating a delirium prediction score. In addition, this software possesses the flexibility to recalibrate the delirium risk based on the availability of the nine clinical variables.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Stanford Hospital geriatric patients having surgery
Key inclusion criteria (5 listed)
- Surgical patients
- Greater than or equal to 65 years old
- ASA I, II or III
- Greater than 90 min of surgery
- Non-cardiac surgery
Key exclusion criteria (7 listed)
- Dementia
- Alzheimer's
- Parkinson's
- Current Benzodiazepine use
- Alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of subjects with postoperative delirium accurately predicted by the PIPRA Tool
Time frame: Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively
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.
Development of post-operative Delirium
Time frame: Up to 72 hours post-operatively
Number of subjects diagnosed with post-operative delirium
Determination of Delirium Phenotype
Time frame: Up to 72 hours post-operatively.
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.
Impact of delirium on post-operative cognitive impairment
Time frame: Up to 10-year post-operatively.
Impact of delirium occurrence and emergence of cognitive impairment post-operatively
Sensitivity and specificity of the PIPRA tool for detecting postoperative delirium.
Time frame: Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively
Sensitivity and specificity of various cut off points of the PIPRA tool for detecting postoperative delirium.
Receiver operating characteristic (ROC) curve analysis of PIPRA tool
Time frame: Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively
Receiver operating characteristic (ROC) curve analysis of PIPRA tool
5 secondary outcomes
Immediate Postoperative Mortality
Time frame: From date of post-operative admission up to time of postoperative discharge, an average of 72 hours.
Length of Hospital Length of Stay
Time frame: From date of post-operative admission up to time of postoperative discharge (assessed up to 1 year after admission).
Discharge Site
Time frame: Type of facility the patient was discharge to from the hospital (assessed up to 6 months from admission)
Requirement of Intensive Care Unit Admission
Time frame: Time to discharge from the hospital (assessed up to 6 months from admission)
Need of pharmacological protocol
Time frame: From post-operative hospital admission up to time of postoperative discharge (assessed up to 6 months from admission)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Results publication: PubMed 33189147Buchan TA, Sadeghirad B, Schmutz N, Goettel N, Foroutan F, Couban R, Mbuagbaw L, Dodsworth BT. Preoperative prognostic factors associated with postoperative delirium in older people undergoing surgery: protocol for a systematic review and individual patient data meta-analysis. Syst Rev. 2020 Nov 14;9(1):261. doi: 10.1186/s13643-020-01518-z.
- Results publication: PubMed 37290122Dodsworth BT, Reeve K, Falco L, Hueting T, Sadeghirad B, Mbuagbaw L, Goettel N, Schmutz Gelsomino N. Development and validation of an international preoperative risk assessment model for postoperative delirium. Age Ageing. 2023 Jun 1;52(6):afad086. doi: 10.1093/ageing/afad086.
- Results publication: PubMed 37819663Sadeghirad B, Dodsworth BT, Schmutz Gelsomino N, Goettel N, Spence J, Buchan TA, Crandon HN, Baneshi MR, Pol RA, Brattinga B, Park UJ, Terashima M, Banning LBD, Van Leeuwen BL, Neerland BE, Chuan A, Martinez FT, Van Vugt JLA, Rampersaud YR, Hatakeyama S, Di Stasio E, Milisen K, Van Grootven B, van der Laan L, Thomson Mangnall L, Goodlin SJ, Lungeanu D, Denhaerynck K, Dhakharia V, Sampson EL, Zywiel MG, Falco L, Nguyen AV, Moss SJ, Krewulak KD, Jaworska N, Plotnikoff K, Kotteduwa-Jayawarden S, Sandarage R, Busse JW, Mbuagbaw L. Perioperative Factors Associated With Postoperative Delirium in Patients Undergoing Noncardiac Surgery: An Individual Patient Data Meta-Analysis. JAMA Netw Open. 2023 Oct 2;6(10):e2337239. doi: 10.1001/jamanetworkopen.2023.37239.
- Results publication: PubMed 28601132Maldonado JR. Acute Brain Failure: Pathophysiology, Diagnosis, Management, and Sequelae of Delirium. Crit Care Clin. 2017 Jul;33(3):461-519. doi: 10.1016/j.ccc.2017.03.013.
- Results publication: PubMed 18686756Robinson TN, Eiseman B. Postoperative delirium in the elderly: diagnosis and management. Clin Interv Aging. 2008;3(2):351-5. doi: 10.2147/cia.s2759.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José R Maldonado, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Postoperative Delirium, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with postoperative delirium accurately predicted by the PIPRA Tool (time frame: Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567574, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.