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.
Condition or disease |
---|
Hyperactive Delirium Hypoactive Delirium Mixed Type Delirium |
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 Type : | Observational |
Actual Enrollment : | 300 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | February 2014 |
Actual Primary Completion Date : | January 2016 |
Actual Study Completion Date : | May 2016 |
Group/Cohort |
---|
Inpatients
Patients admitted to Stanford Hospital and Clinics medical and surgical units
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Inclusion criteria for enrolled patients:
Inclusion criteria for enrolled nurses:
Exclusion Criteria:
For enrolled patients:
United States, California | |
Stanford Hospital and Clinics | |
Stanford, California, United States, 94305 |
Principal Investigator: | Jose R Maldonado, M.D. | Stanford University |
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date | April 14, 2014 | |||
First Posted Date | May 17, 2019 | |||
Last Update Posted Date | May 17, 2019 | |||
Actual Study Start Date | February 2014 | |||
Actual Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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).
|
|||
Original Primary Outcome Measures | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | A Pilot Study of "Stanford Proxy Test for Delirium" (S-PTD) | |||
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 | |||
Brief 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 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 Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
|||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
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. | |||
Condition |
|
|||
Intervention | Not Provided | |||
Study Groups/Cohorts | Inpatients
Patients admitted to Stanford Hospital and Clinics medical and surgical units
|
|||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
300 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | May 2016 | |||
Actual Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT03954769 | |||
Other Study ID Numbers | 28327 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Jose R Maldonado, MD, Stanford University | |||
Study Sponsor | Stanford University | |||
Collaborators | Not Provided | |||
Investigators |
|
|||
PRS Account | Stanford University | |||
Verification Date | April 2019 |