Hyperactive DeliriumNCT03954769
A Pilot Study of "Stanford Proxy Test for Delirium" (S-PTD)
An observational study of Hyperactive Delirium and Hypoactive Delirium, run by Stanford University at 1 site in United States.
Trial summary
Although there are several tools available for the screening of delirium among the medically ill, they all have some limitations. First, none of the available tools have been validated against newly developed and published DSM-5 (Diagnostic and Statistical Manual) or ICD-10 (International Statistical Classification of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperactive Delirium, Hypoactive Delirium, Mixed Type Delirium
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to May 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to selected Stanford Hospital and Clinics general medical/surgical units, for any diagnosis. Both female and male patients, English or Spanish-speaking subjects, age 18 and above, of any ethnic background will be recruited.
Who may be able to join
- all inpatients admitted to Stanford Hospital's selected general medical and surgical units
- patients must be able to communicate and read English and/or Spanish
- ages 18 and older
- All nurses assigned to each enrolled patient for the shift during which that patient is enrolled, will be invited to participate in the study to assess the tool's acceptability and ease of use.
Who cannot join
- For enrolled patients:
- unable to speak English or Spanish.
- unwillingness to participate in the study
- for patients who are unable to consent (i.e., lack capacity), either the lack of availability of a suitable surrogate or the surrogate's unwillingness to provide consent
- For enrolled nurses: unwillingness to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Stanford, California, 94305
About this study
Official title: A Pilot Study of the Psychometric Properties of the "Stanford Proxy Test for Delirium" (S-PTD): a New Screening Tool for the Detection of Delirium
Although there are several tools available for the screening of delirium among the medically ill, they all have some limitations. First, none of the available tools have been validated against newly developed and published DSM-5 (Diagnostic and Statistical Manual) or ICD-10 (International Statistical Classification of Diseases and Related Health Problems) criteria. Additionally, all the screening/diagnostic tools presently available have the same limitation, they all require significant patient involvement and participation (e.g., questions and activities) in order to complete the assessment. By definition, delirium is a neuropsychiatric disorder characterized by disturbance in attention and awareness, and additional disturbance in cognition (e.g., memory deficit, disorientation), language, visuospatial ability, or perception. The intrinsic characteristics of delirium seem to interfere with the patient's ability to participate and complete many of the tasks associated with delirium evaluation itself. Finally, most available tools seem to narrowly focus on some neurocognitive areas of delirium, but not being comprehensive enough.
In contrast, the S-PTD is designed so it can be completed by the nursing staff caring for the patients, the medical personnel most intimately involved with the care and aware of the behaviors exhibited by the patient during the course of their hospital stay. The idea is that nurses will complete the screening tool (hence the term "by proxy"), based on the behaviors and interactions observed during the course of a conventional "nursing shift", to determine whether the patient meets current neuropsychiatric criteria for the diagnosis of delirium.
Read the detailed description
Patients admitted to Stanford Hospital and Clinics medical and surgical units meeting the study's inclusion and exclusion criteria will be considered for enrollment during the recruitment phase.
The research personnel, under the supervision of the study PI (an expert in delirium), will perform daily study procedures as follows:
A member of the research team will obtain a list of all newly admitted patients from the prior 24 hours each Monday through Friday morning from the unit's nurse manager. A member of the research team will also look at daily operating room schedules for patients to be admitted to participating units post-operatively, having received permission to do so from the directors of participating medical/surgical services. Given that the purpose of this tool is to screen for a condition that may occur in medically ill patients, every newly admitted patient or their surrogate (for those lacking decisional making capacity), meeting inclusion criteria will be approached for participation in the study and asked to provide consent. Patients lacking capacity for consent will not be automatically excluded, given that the inclusion of delirious patients is critical for adequate evaluation of the S-PTD, and most delirious patients, by definition, lack capacity to provide informed consent. We will ask for the consent from surrogate decision makers in these cases.
In addition, it is anticipated that some patients who meet eligibility will be unable to sign a consent form due to physical limitations related to their hospitalization (e.g. patients recovering from recent surgery). If a patient is unable to sign the consent form due to physical limitations, oral consent will be obtained. Oral consent will also be used in the event that a patient lacks capacity and has no surrogate decision-maker at bedside, but a surrogate decision-maker is available by phone. For Spanish-speaking patients, consent will be obtained by the same procedures utilizing Spanish-language written/oral consent, with the help of SHC interpreter services.
For each patient that consents to participate in the study, the nurse assigned to that patient during the shift will be approached. These nurses will additionally be asked to provide consent, as they are also subjects of the study.
All patients will be followed for the duration of their hospital stay (expected to average 5 days), to a maximum of two weeks, except in the case of delirious patients, who will be followed until the resolution of the episode of delirium.
Every day, enrolled patients will undergo two, separate evaluations. Towards the end of their shift (within the last 2-hrs of each shift) the patient's nurse will complete the S-PTD, utilizing all available data from the entire nursing shift (8-12 hours, depending the unit's shift mode), which allows nurses to take into account all of nurse's interactions and observations across the entire shift (including direct interactions between the patient and the nurse, family and all clinical staff). In addition, patients will undergo a clinical neuropsychiatric examination performed by a neuropsychiatrist (the gold standard), estimated to take about 5 minutes. The examiners will be blind to the results of each other's exam. Finally, a member of the research team, blind to the results of the previous tests, will conduct a separate interview of the patient's nurse towards the end of the shift in order collect the nurse's forms and evaluate the nurse's opinions regarding the ease to complete the S-PTD.
Later the results of the S-PTD will be compared against the results of the neuropsychiatric examination. The sensitivity, specificity, positive predictive value, and negative predictive value of the S-PTD will be calculated as compared to the results of clinical neuropsychiatric evaluation based on DSM-5 criteria.
- Keywords
- Delirium,, Confusion Assessment Method, Proxy Test of Delirium, DSM-V, Hyperactive Delirium, Hypoactive Delirium, Mixed-type delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatients | Patients admitted to Stanford Hospital and Clinics medical and surgical units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
Every day, enrolled patients will undergo two evaluations: (1) At the end of the nursing shift, nurses will complete the S-PTD based on the entirety of the interactions with the patient throughout the course of their shift, estimated to take about 2-3 minutes; (2) then, within 1-hour of the nurse's S-PTD assessment a member of the Psychosomatic Medicine Service will conduct a blinded clinical neuropsychiatric examination (the gold standard for delirium diagnosis). At the end of their nursing shift (either 8 or 12 hours).
Measured: The study will be carried out over a 2-year period; patients will be followed throughout the hospital stay, for a maximum of 2-weeks from the time of admission, or until discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study startFeb 2014
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hyperactive 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 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
- Jose R Maldonado, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954769
- Sponsor's protocol ID
- 28327
- Status last verified
- Apr 2019
- First submitted
- 14 Apr 2014
- Last updated
- 17 May 2019
- Results posted
- No
Publications
Maldonado JR. Delirium in the acute care setting: characteristics, diagnosis and treatment. Crit Care Clin. 2008 Oct;24(4):657-722, vii. doi: 10.1016/j.ccc.2008.05.008.
PubMed 18929939Siddiqi N, House AO, Holmes JD. Occurrence and outcome of delirium in medical in-patients: a systematic literature review. Age Ageing. 2006 Jul;35(4):350-64. doi: 10.1093/ageing/afl005. Epub 2006 Apr 28.
PubMed 16648149Ryan DJ, O'Regan NA, Caoimh RO, Clare J, O'Connor M, Leonard M, McFarland J, Tighe S, O'Sullivan K, Trzepacz PT, Meagher D, Timmons S. Delirium in an adult acute hospital population: predictors, prevalence and detection. BMJ Open. 2013 Jan 7;3(1):e001772. doi: 10.1136/bmjopen-2012-001772.
PubMed 23299110Norbaek J, Glipstrup E. Delirium is seen in one-third of patients in an acute hospital setting. Identification, pharmacologic and non-pharmacologic treatment is inadequate. Dan Med J. 2016 Nov;63(11):A5293.
PubMed 27808035
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Psychometric Properties of the "Stanford Proxy Test for Delirium" (S-PTD): a New Screening Tool for the Detection of Delirium
- ClinicalTrials.gov ID
- NCT03954769
- Acronym / sponsor ID
- 28327
- Keywords
- Delirium,, Confusion Assessment Method, Proxy Test of Delirium, DSM-V, Hyperactive Delirium, Hypoactive Delirium, Mixed-type delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 May 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.
Although there are several tools available for the screening of delirium among the medically ill, they all have some limitations. First, none of the available tools have been validated against newly developed and published DSM-5 (Diagnostic and Statistical Manual) or ICD-10 (International Statistical Classification of Diseases and Related Health Problems) criteria. Additionally, all the screening/diagnostic tools presently available have the same limitation, they all require significant patient involvement and participation (e.g., questions and activities) in order to complete the assessment. By definition, delirium is a neuropsychiatric disorder characterized by disturbance in attention and awareness, and additional disturbance in cognition (e.g., memory deficit, disorientation), language, visuospatial ability, or perception. The intrinsic characteristics of delirium seem to interfere with the patient's ability to participate and complete many of the tasks associated with delirium evaluation itself. Finally, most available tools seem to narrowly focus on some neurocognitive areas of delirium, but not being comprehensive enough.
In contrast, the S-PTD is designed so it can be completed by the nursing staff caring for the patients, the medical personnel most intimately involved with the care and aware of the behaviors exhibited by the patient during the course of their hospital stay. The idea is that nurses will complete the screening tool (hence the term "by proxy"), based on the behaviors and interactions observed during the course of a conventional "nursing shift", to determine whether the patient meets current neuropsychiatric criteria for the diagnosis of delirium.
Detailed description
Patients admitted to Stanford Hospital and Clinics medical and surgical units meeting the study's inclusion and exclusion criteria will be considered for enrollment during the recruitment phase.
The research personnel, under the supervision of the study PI (an expert in delirium), will perform daily study procedures as follows:
A member of the research team will obtain a list of all newly admitted patients from the prior 24 hours each Monday through Friday morning from the unit's nurse manager. A member of the research team will also look at daily operating room schedules for patients to be admitted to participating units post-operatively, having received permission to do so from the directors of participating medical/surgical services. Given that the purpose of this tool is to screen for a condition that may occur in medically ill patients, every newly admitted patient or their surrogate (for those lacking decisional making capacity), meeting inclusion criteria will be approached for participation in the study and asked to provide consent. Patients lacking capacity for consent will not be automatically excluded, given that the inclusion of delirious patients is critical for adequate evaluation of the S-PTD, and most delirious patients, by definition, lack capacity to provide informed consent. We will ask for the consent from surrogate decision makers in these cases.
In addition, it is anticipated that some patients who meet eligibility will be unable to sign a consent form due to physical limitations related to their hospitalization (e.g. patients recovering from recent surgery). If a patient is unable to sign the consent form due to physical limitations, oral consent will be obtained. Oral consent will also be used in the event that a patient lacks capacity and has no surrogate decision-maker at bedside, but a surrogate decision-maker is available by phone. For Spanish-speaking patients, consent will be obtained by the same procedures utilizing Spanish-language written/oral consent, with the help of SHC interpreter services.
For each patient that consents to participate in the study, the nurse assigned to that patient during the shift will be approached. These nurses will additionally be asked to provide consent, as they are also subjects of the study.
All patients will be followed for the duration of their hospital stay (expected to average 5 days), to a maximum of two weeks, except in the case of delirious patients, who will be followed until the resolution of the episode of delirium.
Every day, enrolled patients will undergo two, separate evaluations. Towards the end of their shift (within the last 2-hrs of each shift) the patient's nurse will complete the S-PTD, utilizing all available data from the entire nursing shift (8-12 hours, depending the unit's shift mode), which allows nurses to take into account all of nurse's interactions and observations across the entire shift (including direct interactions between the patient and the nurse, family and all clinical staff). In addition, patients will undergo a clinical neuropsychiatric examination performed by a neuropsychiatrist (the gold standard), estimated to take about 5 minutes. The examiners will be blind to the results of each other's exam. Finally, a member of the research team, blind to the results of the previous tests, will conduct a separate interview of the patient's nurse towards the end of the shift in order collect the nurse's forms and evaluate the nurse's opinions regarding the ease to complete the S-PTD.
Later the results of the S-PTD will be compared against the results of the neuropsychiatric examination. The sensitivity, specificity, positive predictive value, and negative predictive value of the S-PTD will be calculated as compared to the results of clinical neuropsychiatric evaluation based on DSM-5 criteria.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatients | – | –Patients admitted to Stanford Hospital and Clinics medical and surgical units |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to selected Stanford Hospital and Clinics general medical/surgical units, for any diagnosis. Both female and male patients, English or Spanish-speaking subjects, age 18 and above, of any ethnic background will be recruited.
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
- For enrolled patients:
- For enrolled nurses: unwillingness to participate in the study.
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
Incidence of delirium
Time frame: The study will be carried out over a 2-year period; patients will be followed throughout the hospital stay, for a maximum of 2-weeks from the time of admission, or until discharge.
Every day, enrolled patients will undergo two evaluations: (1) At the end of the nursing shift, nurses will complete the S-PTD based on the entirety of the interactions with the patient throughout the course of their shift, estimated to take about 2-3 minutes; (2) then, within 1-hour of the nurse's S-PTD assessment a member of the Psychosomatic Medicine Service will conduct a blinded clinical neuropsychiatric examination (the gold standard for delirium diagnosis). At the end of their nursing shift (either 8 or 12 hours).
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 17 May 2019.
- Background: PubMed 18929939Maldonado JR. Delirium in the acute care setting: characteristics, diagnosis and treatment. Crit Care Clin. 2008 Oct;24(4):657-722, vii. doi: 10.1016/j.ccc.2008.05.008.
- Background: PubMed 16648149Siddiqi N, House AO, Holmes JD. Occurrence and outcome of delirium in medical in-patients: a systematic literature review. Age Ageing. 2006 Jul;35(4):350-64. doi: 10.1093/ageing/afl005. Epub 2006 Apr 28.
- Background: PubMed 23299110Ryan DJ, O'Regan NA, Caoimh RO, Clare J, O'Connor M, Leonard M, McFarland J, Tighe S, O'Sullivan K, Trzepacz PT, Meagher D, Timmons S. Delirium in an adult acute hospital population: predictors, prevalence and detection. BMJ Open. 2013 Jan 7;3(1):e001772. doi: 10.1136/bmjopen-2012-001772.
- Background: PubMed 27808035Norbaek J, Glipstrup E. Delirium is seen in one-third of patients in an acute hospital setting. Identification, pharmacologic and non-pharmacologic treatment is inadequate. Dan Med J. 2016 Nov;63(11):A5293.
Related trials for Hyperactive Delirium
Not yet recruitingPhase 4
Safety and Efficacy of Esketamine - Dexmedetomidine Combination Versus Dexmedetomidine Monotherapy for Hyperactive Delirium in ICU Patients on Non-Invasive Respiratory Support (SEED-NIRS Trial): Study Protocol of a Randomized Controlled Trial
Dexmedetomidine, Ketamine
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Intelligent Intensive Care Unit
Delirium, Confusion
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.
Jose R Maldonado, M.D. 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 Hyperactive Delirium and Hypoactive 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 4 inclusion and 5 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 17 May 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 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?
Incidence of delirium (time frame: The study will be carried out over a 2-year period; patients will be followed throughout the hospital stay, for a maximum of 2-weeks from the time of admission, or until discharge.). 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 NCT03954769, which also lists 4 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 17 May 2019.