DeliriumNCT04084821
Estimation of Delirium Data Completeness
An observational study of Delirium and Delirium Drug-Induced, run by Efficacy Care R&D Ltd at 1 site in Israel.
Trial summary
Currently physicians and nurses rely on their own clinical skills and experience to diagnose and record 'delirium' in the Electronic Health Records (EHR). This study aims to determine how delirium as a diagnosis is documented by clinicians in the EHR at Hadassah Hospital. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium, Delirium Drug-Induced, Delirium Confusional State
- What is being tested?
- none - observation only
- How many people
- 50,000 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2019to Nov 2020
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sample Size: 50,000 Gender: M - 25,000; F - 25000 approx. Age: 18 and older General Health Status: All postoperative patients undergoing unplanned admission to an intensive care unit (ICU). Total Number of Subjects Projected: It is expected that approximately 75,000 subjects will be enrolled (identified for further review) to produce 50,000 evaluable subjects.
Who may be able to join
- All postoperative patients aged 18 years and older; and
- Undergoing unplanned admission to an intensive care unit (ICU); or
- Major complications associated with either operating room procedure or anesthesia. Example: Cardiac or circulatory event and/or Cardiac arrest during or within 24 hours of operation or administration of anesthesia; or Acute myocardial infarction (AMI) during or within 48 hours of operation or administration of anesthesia; or
- Postoperative Central Nervous System (CNS) event (e.g., CVA, seizures, coma) during or within 48 hours of operation or administration of anesthesia; AND
- Respiratory failure not present prior to the 25th hour of hospitalization or not present before surgery;
Who cannot join
- Delirium present on admission; or
- any psychotic or degenerative related diagnosis on admission (e.g. Senile and presentile dementias such as Alzheimer's or Pick's dementia, Creutzfeldt-Jakob disease, Huntington's chorea, Wilson's disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Delirium Data Completeness and Analysis of Underlying Systems Factors in a Retrospective Cohort
Currently physicians and nurses rely on their own clinical skills and experience to diagnose and record 'delirium' in the Electronic Health Records (EHR). This study aims to determine how delirium as a diagnosis is documented by clinicians in the EHR at Hadassah Hospital. The knowledge gained from this study will support the design of a better surveillance approach to monitoring delirium events in postoperative patients using electronic healthcare recorded data.
There is considerable uncertainty surrounding the quality of 'delirium' records in the Electronic Health Records (EHR). The reliability of this chart estimation has become questionable in the absence of an objective definition of 'delirium' and a lack of highly accurate diagnostic tools in the hospital setting.
Given the difficulty of accurately identifying delirium and the deficiency in the quality of EHR documentation, it is not surprising that delirium is grossly underestimated, undertreated, not properly recorded in the EHR or misreported. Data concordance plays a major role in documentation quality, especially for data-mining and knowledge extraction analysis, and therefore it is essential to address the reliability of 'delirium' labeled data within the EHR system.
Read the detailed description
Clinical Background::
Postoperative encephalopathy known as "delirium" is a deleterious, potentially risky, and often preventable complication representing a serious "brain failure" condition, commonly seen in the intensive care unit (ICU) setting.
The etiology of postoperative delirium (POD) is likely to be a consequence of the physiological and biochemical derangement induced by the underlying surgical pathology, surgical trauma, pain, analgesia, and anesthesia. Common pathophysiological factors, processes, and conditions leading to delirium are multifactorial and could involve neurotransmitters, inflammatory processes, drugs, and oxygenation impairment. Multifactorial perioperative factors, such as anesthesia and adjuvant drugs, also play important roles in contributing to postoperative delirium. Perioperative care is, therefore, a potential focus for investigation of data-driven evidence to understand the POD prior to developing effective intervention tool.
Delirium Burden::
Delirium creates distinct emotional distress in patients, family and caregivers.
The burden of illness due to delirium is significant, with a higher incidence of postoperative complications, prolonged length of ICU and hospital stay, resulting in 30-day mortality and unplanned readmission when compared to patients without delirium. The long-term prospects of delirious patients show poor quality of life ('QoL') indicators related to functional decline, new institutionalization, persistent cognitive impairments and higher mortality, with persistent cognitive impairments in 12% of previously "cognitively well" patients, and an even higher percentage in elderly, obese, and previously admitted patients. The postoperative delirium is associated with longer-term cognitive decline and potentially 'portends descent to dementia' .
The mortality rate associated with delirium is approximately 40% , as high as acute myocardial infarction. The total cost estimates attributable to delirium ranged from $16,303 to $64,421 per patient, implying that the national burden of delirium on the health care system ranges from $38 billion to $152 billion each year in US. This cost is highly comparable to the substantial costs of falls and diabetes, which emphasizes the need to address this costly disorder with increased timeliness and urgency.
Standard of Care::
Efforts to detect delirium have relied upon two major methods , both of which fall short of the practical needs of a modern hospital environment. Screening instruments, largely based upon chart review, well-investigated risk factors and patient interview, have been unsuccessful due to the challenges of implementing these into clinical workflows and providing ongoing training for healthcare providers to use such instruments. In addition, they exhibit poor sensitivity in routine use. While the early detection of delirium provides clear and significant advantages in effective treatment, the screening tools available for the disorder are not efficient or effective enough to do so. Delirium is often underrecognized and misdiagnosed, exemplified in a 2014 study that found that the successful detection of the disorder by staff was only at 23%, even after extensive multimodal education about the disorder and how best to detect it.
Despite its importance for patient safety and public health, delirium is often unrecognized by clinicians, therefore the effective strategies of intervention remain elusive. Moreover, the presentation of delirium is heterogeneous and multifaceted, and measurement of delirium and its severity pose unique challenges.
Unmet Need::
The need exists for an objective, affordable and reliable modern assessment with the ability of early recognition, improved screening, and continuous monitoring of postoperative encephalopathy. The potential impact of such a tool has been recognized as highly important for the establishment of evidence-based data for better tracking prognosis, monitoring response to treatment and estimating the burden of care both during and after hospitalization. Nurses themselves recognize this unmet need. Many have argued that the current screening tests are too subjective and rely on each tester's interpretation.
Concept Creation::
The era of "Medical Big Data" and next-generation health analytics is well upon us. Conceptually, "Big Data" may include data-driven clinical features considered to be hidden, uncertain, unrecoverable and unmanageable for human interpretation without the help of computerized data processing and advance data-driven algorithms. As delirium in post-surgical patients is often hard to recognize and remains a largely untreated condition, it is hypothesized that an exploratory analysis of historical medical records by using an advanced algorithm could reveal novel and improved knowledge about the nature of delirium. However, the quality, computability, reliability, accuracy and completeness of the data are questionable.
Therefore this study aims to perform a retrospective exploratory analysis of historical records locked in one or more clinical databases (i.e. Metavision, EHR, AIMS, etc.), and/or in one or more hospital settings.
- Conditions
- Delirium, Delirium Drug-Induced, Delirium Confusional State, Delirium, Cause Unknown, Delirium of Mixed Origin
- Being tested
- none - observation only
- Medical subject headings
- Delirium, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none - observation onlyOther
Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium
The primary outcomes measured in this study are the number of cases determining the presence, absence, or likelihood of subsequent development of postoperative delirium.
(ICD-9-CM Codes Considered Evidence of Delirium: 290.3 Senile dementia with delirium; or 291 Alcohol-induced mental disorders; or 291.0 Alcohol withdrawal delirium; or 292 Drug-induced mental disorders; or 292.81 Drug-induced delirium; or 293 Transient mental disorders due to conditions classified elsewhere; or 293.1 Subacute delirium; or 780.09 Other alteration of consciousness )
Measured: 12 months
Secondary outcomes (9)
Severity of delirium
CAM-S Score::
Delirium severity measure based on the Confusion Assessment Method (CAM-S). The severity score is created by an additive summary of the ratings ranging from 0-19 (long form). Higher scores indicate more severe delirium.
Measured: 30 days
Severity of delirium
DRS-R98 Score::
The Delirium Rating Scale (DRS) is a widely used delirium rating instrument that specifically, sensitively, and reliably measures delirium symptoms as rated by a psychiatrist or trained clinician.
Severity items are rated on a scale of 0-3 and diagnostic items are rated on a scale of 0-2 or 0-3. The maximum possible score for severity items is 39, while the maximum total score is 46. Higher scores indicate more severe delirium; score of 0 indicates no delirium.
Measured: 30 days
ICU LOS
days of Unplanned ICU hospitalization
Measured: 30 days
In-patient mortality
In-patient mortality
Measured: 12 months
ICER
The incremental cost-effectiveness ratio (ICER)
Measured: 12 months
Readmission
30-day readmission
Measured: 30 days
in hospital mortality
30-day hospital mortality
Measured: 30 days
Direct Costs of Hospitalisation
Total Hospitalization costs, including procedural complication costs, and/or any costs of pre-discharge treatment, drug, procedure-related complications and re-interventions;
Measured: 30 days
LOS
days of none-ICU hospitalization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efficacy Care R&D Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084821
- Sponsor's protocol ID
- Delirium-Retrospective Cohort
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Delirium Data Completeness and Analysis of Underlying Systems Factors in a Retrospective Cohort
- ClinicalTrials.gov ID
- NCT04084821
- Acronym / sponsor ID
- Delirium-Retrospective Cohort
- Conditions
- Delirium, Delirium Drug-Induced, Delirium Confusional State, Delirium, Cause Unknown, Delirium of Mixed Origin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Efficacy Care R&D LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- Oct 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 10 Sep 2019 (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.
Currently physicians and nurses rely on their own clinical skills and experience to diagnose and record 'delirium' in the Electronic Health Records (EHR). This study aims to determine how delirium as a diagnosis is documented by clinicians in the EHR at Hadassah Hospital. The knowledge gained from this study will support the design of a better surveillance approach to monitoring delirium events in postoperative patients using electronic healthcare recorded data.
There is considerable uncertainty surrounding the quality of 'delirium' records in the Electronic Health Records (EHR). The reliability of this chart estimation has become questionable in the absence of an objective definition of 'delirium' and a lack of highly accurate diagnostic tools in the hospital setting.
Given the difficulty of accurately identifying delirium and the deficiency in the quality of EHR documentation, it is not surprising that delirium is grossly underestimated, undertreated, not properly recorded in the EHR or misreported. Data concordance plays a major role in documentation quality, especially for data-mining and knowledge extraction analysis, and therefore it is essential to address the reliability of 'delirium' labeled data within the EHR system.
Detailed description
Clinical Background::
Postoperative encephalopathy known as "delirium" is a deleterious, potentially risky, and often preventable complication representing a serious "brain failure" condition, commonly seen in the intensive care unit (ICU) setting.
The etiology of postoperative delirium (POD) is likely to be a consequence of the physiological and biochemical derangement induced by the underlying surgical pathology, surgical trauma, pain, analgesia, and anesthesia. Common pathophysiological factors, processes, and conditions leading to delirium are multifactorial and could involve neurotransmitters, inflammatory processes, drugs, and oxygenation impairment. Multifactorial perioperative factors, such as anesthesia and adjuvant drugs, also play important roles in contributing to postoperative delirium. Perioperative care is, therefore, a potential focus for investigation of data-driven evidence to understand the POD prior to developing effective intervention tool.
Delirium Burden::
Delirium creates distinct emotional distress in patients, family and caregivers.
The burden of illness due to delirium is significant, with a higher incidence of postoperative complications, prolonged length of ICU and hospital stay, resulting in 30-day mortality and unplanned readmission when compared to patients without delirium. The long-term prospects of delirious patients show poor quality of life ('QoL') indicators related to functional decline, new institutionalization, persistent cognitive impairments and higher mortality, with persistent cognitive impairments in 12% of previously "cognitively well" patients, and an even higher percentage in elderly, obese, and previously admitted patients. The postoperative delirium is associated with longer-term cognitive decline and potentially 'portends descent to dementia' .
The mortality rate associated with delirium is approximately 40% , as high as acute myocardial infarction. The total cost estimates attributable to delirium ranged from $16,303 to $64,421 per patient, implying that the national burden of delirium on the health care system ranges from $38 billion to $152 billion each year in US. This cost is highly comparable to the substantial costs of falls and diabetes, which emphasizes the need to address this costly disorder with increased timeliness and urgency.
Standard of Care::
Efforts to detect delirium have relied upon two major methods , both of which fall short of the practical needs of a modern hospital environment. Screening instruments, largely based upon chart review, well-investigated risk factors and patient interview, have been unsuccessful due to the challenges of implementing these into clinical workflows and providing ongoing training for healthcare providers to use such instruments. In addition, they exhibit poor sensitivity in routine use. While the early detection of delirium provides clear and significant advantages in effective treatment, the screening tools available for the disorder are not efficient or effective enough to do so. Delirium is often underrecognized and misdiagnosed, exemplified in a 2014 study that found that the successful detection of the disorder by staff was only at 23%, even after extensive multimodal education about the disorder and how best to detect it.
Despite its importance for patient safety and public health, delirium is often unrecognized by clinicians, therefore the effective strategies of intervention remain elusive. Moreover, the presentation of delirium is heterogeneous and multifaceted, and measurement of delirium and its severity pose unique challenges.
Unmet Need::
The need exists for an objective, affordable and reliable modern assessment with the ability of early recognition, improved screening, and continuous monitoring of postoperative encephalopathy. The potential impact of such a tool has been recognized as highly important for the establishment of evidence-based data for better tracking prognosis, monitoring response to treatment and estimating the burden of care both during and after hospitalization. Nurses themselves recognize this unmet need. Many have argued that the current screening tests are too subjective and rely on each tester's interpretation.
Concept Creation::
The era of "Medical Big Data" and next-generation health analytics is well upon us. Conceptually, "Big Data" may include data-driven clinical features considered to be hidden, uncertain, unrecoverable and unmanageable for human interpretation without the help of computerized data processing and advance data-driven algorithms. As delirium in post-surgical patients is often hard to recognize and remains a largely untreated condition, it is hypothesized that an exploratory analysis of historical medical records by using an advanced algorithm could reveal novel and improved knowledge about the nature of delirium. However, the quality, computability, reliability, accuracy and completeness of the data are questionable.
Therefore this study aims to perform a retrospective exploratory analysis of historical records locked in one or more clinical databases (i.e. Metavision, EHR, AIMS, etc.), and/or in one or more hospital settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sample Size: 50,000 Gender: M - 25,000; F - 25000 approx. Age: 18 and older General Health Status: All postoperative patients undergoing unplanned admission to an intensive care unit (ICU). Total Number of Subjects Projected: It is expected that approximately 75,000 subjects will be enrolled (identified for further review) to produce 50,000 evaluable subjects.
Key inclusion criteria (5 listed)
- All postoperative patients aged 18 years and older; and
- Undergoing unplanned admission to an intensive care unit (ICU); or
- Major complications associated with either operating room procedure or anesthesia. Example: Cardiac or circulatory event and/or Cardiac arrest during or within 24 hours of operation or administration of anesthesia; or Acute myocardial infarction (AMI) during or within 48 hours of operation or administration of anesthesia; or
- Postoperative Central Nervous System (CNS) event (e.g., CVA, seizures, coma) during or within 48 hours of operation or administration of anesthesia; AND
- Respiratory failure not present prior to the 25th hour of hospitalization or not present before surgery;
Key exclusion criteria (2 listed)
- Delirium present on admission; or
- any psychotic or degenerative related diagnosis on admission (e.g. Senile and presentile dementias such as Alzheimer's or Pick's dementia, Creutzfeldt-Jakob disease, Huntington's chorea, Wilson's disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none - observation onlyObservational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data | Other | – |
Primary outcome
Postoperative Delirium
Time frame: 12 months
The primary outcomes measured in this study are the number of cases determining the presence, absence, or likelihood of subsequent development of postoperative delirium. (ICD-9-CM Codes Considered Evidence of Delirium: 290.3 Senile dementia with delirium; or 291 Alcohol-induced mental disorders; or 291.0 Alcohol withdrawal delirium; or 292 Drug-induced mental disorders; or 292.81 Drug-induced delirium; or 293 Transient mental disorders due to conditions classified elsewhere; or 293.1 Subacute delirium; or 780.09 Other alteration of consciousness )
9 secondary outcomes
Severity of delirium
Time frame: 30 days
Severity of delirium
Time frame: 30 days
ICU LOS
Time frame: 30 days
In-patient mortality
Time frame: 12 months
ICER
Time frame: 12 months
Readmission
Time frame: 30 days
in hospital mortality
Time frame: 30 days
Direct Costs of Hospitalisation
Time frame: 30 days
LOS
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Delirium Drug-Induced, run by Efficacy Care R&D Ltd at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 10 Sep 2019. 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 Israel. 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?
Results are not available in the source record.
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?
Postoperative Delirium (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2019.