DeliriumFAM-CAPDNCT05220761
Family Assessment of Pediatric Delirium
An observational study of Delirium, run by University of Calgary at 2 sites in Canada.
Trial summary
In this study the investigators will assess the validity, reliability and acceptability of utilizing family members to complete a delirium screen using the Cornell Assessment of Pediatric Delirium (CAPD). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Delirium
- What is being tested?
- Cornell Assessment of Pediatric Delirium
- How many people
- 235 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Aug 2021to 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children admitted to 2 PICUs in Canada with an expected length of stay of >/= 48 hours
Who may be able to join
- Admitted to Alberta Children's Hospital or McMaster Children's Hospital PICU during study enrollment period
- Anticipated length of stay in PICU >/=48 hours
- Substitute decision maker with the ability to provide informed consent
- Primary caregiver available for CAPD assessments,
- Primary caregiver is defined as the person primarily responsible for the care and upbringing of a child and could include: Parents, designated older sibling, foster parents/guardians, or grandparents, who fulfill this definition. There may be more than one primary caregiver for each child
- Translated CAPD and educational materials available in primary spoken language (French, Chinese, Italian or Spanish)
Who cannot join
- Anticipated discharge/transfer within 24 hours II. Family member unable to understand the instructions for CAPD assessment
- This will be identified by the research assistant in collaboration with the bedside care team. i.e. language/cognitive barrier III. Child in irreversible coma (i.e. persistent vegetative state, RASS -4/SBS -2 or less and not reversible)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Laurie A. Lee
Calgary, Alberta, T2T 5T3
McMaster Children's Hospital
Hamilton, Ontario
About this study
Official title: FAM-CAPD: Family Assessment of Pediatric Delirium
In this study the investigators will assess the validity, reliability and acceptability of utilizing family members to complete a delirium screen using the Cornell Assessment of Pediatric Delirium (CAPD).
Read the detailed description
Diagnosing delirium in the heterogenous PICU population is difficult. There is significant variability in pre-morbid neurodevelopmental status in children due to both age-related development as well as pre-morbid cognitive delay. The Cornell Assessment of Pediatric Delirium (CAPD) has been validated in children of all ages and developmental stages. Several confounding factors have been identified that decrease the specificity of delirium detection and include confounding syndromes (i.e. iatrogenic withdrawal syndrome), pre-existing neuro-cognitive delay, and the specialty, experience and training of the assessor. Furthermore, pediatric critical care nurses have many competing interests in prioritizing care for their patients and can struggle with trying to familiarize themselves with the concept of delirium. This is a recognized barrier to routine compliance with delirium screening in PICUs. Family screening may be extremely valuable in early identification of delirium. This has been demonstrated in the critically ill adult population, however, with respect to family detection of delirium in their own children, the reliability of a pediatric screening tool has not been evaluated.
The proposed work is designed to improve both processes of care, by improving delirium screening, and patient outcomes by engaging families in the identification, prevention and management of delirium, in critically ill children.
This study will be conducted at 2 academic PICUs in Canada. Eligible children will be consented and enrolled. Parents/caregivers will be given brief education on delirium assessment and then complete a family tool based on the Cornell Assessment of Pediatric Delirium (CAPD). This will then be validated against the RN completed CAPD.
In order to also assess the acceptability of family detection of PICU delirium interviews of family members and focus groups of HCP will be conducted using qualitative methodology to determine acceptance and feasibility and to guide future knowledge translation work.
- Conditions
- Delirium
- Being tested
- Cornell Assessment of Pediatric Delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cornell Assessment of Pediatric DeliriumDiagnostic test
Also called State Behavioral Scale, Richmond Agitation and Sedation Scale
Cornell Assessment of Pediatric Delirium is a diagnostic test for PICU delirium State Behavioral Scale and Richmond Agitation and Sedation Scale are diagnostic tests for sedation and agitation in children
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of delirium screening by caregivers
Evaluate the validity of delirium screening by family or caregivers using the cornel assessment of pediatric delirium on their own children while they are admitted to a PICU
Measured: 1-28 days
Secondary outcomes (3)
Healthcare professional acceptability of family administered delirium assessment
Explore health care professionals perception and acceptability of family administered delirium assessment in critically ill children
Measured: Up to 1 year
Family/caregiver acceptability of family administered delirium assessment
Explore family member/caregiver perception and acceptability of family administered delirium assessment in critically ill children
Measured: Up to 1 year
Correlation between absolute score of Richmond Agitation and sedation Scale and State Behavioral Scale.
To assess the correlation between the absolute score of the Richmond Agitation and Sedation Scale [-5(unarousable) to +4(Combative)] and the State Behavioral Scale [-3 (unresponsive) to +2(agitated)] for each child in assessing sedation and agitation in critically ill children
Measured: 1-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start9 Aug 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (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.
- More trials run by University of CalgaryThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital Research Institute
- Responsible party
- Principal investigator, Laurie Lee, University of Calgary
- Investigators
- Laurie A. Lee, MN, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220761
- Sponsor's protocol ID
- REB 20-2149
- Acronym
- FAM-CAPD
- Status last verified
- Oct 2022
- First submitted
- 3 Jun 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAM-CAPD: Family Assessment of Pediatric Delirium
- ClinicalTrials.gov ID
- NCT05220761
- Acronym / sponsor ID
- FAM-CAPD / REB 20-2149
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital Research Institute
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 2 Feb 2022 (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.
In this study the investigators will assess the validity, reliability and acceptability of utilizing family members to complete a delirium screen using the Cornell Assessment of Pediatric Delirium (CAPD).
Detailed description
Diagnosing delirium in the heterogenous PICU population is difficult. There is significant variability in pre-morbid neurodevelopmental status in children due to both age-related development as well as pre-morbid cognitive delay. The Cornell Assessment of Pediatric Delirium (CAPD) has been validated in children of all ages and developmental stages. Several confounding factors have been identified that decrease the specificity of delirium detection and include confounding syndromes (i.e. iatrogenic withdrawal syndrome), pre-existing neuro-cognitive delay, and the specialty, experience and training of the assessor. Furthermore, pediatric critical care nurses have many competing interests in prioritizing care for their patients and can struggle with trying to familiarize themselves with the concept of delirium. This is a recognized barrier to routine compliance with delirium screening in PICUs. Family screening may be extremely valuable in early identification of delirium. This has been demonstrated in the critically ill adult population, however, with respect to family detection of delirium in their own children, the reliability of a pediatric screening tool has not been evaluated.
The proposed work is designed to improve both processes of care, by improving delirium screening, and patient outcomes by engaging families in the identification, prevention and management of delirium, in critically ill children.
This study will be conducted at 2 academic PICUs in Canada. Eligible children will be consented and enrolled. Parents/caregivers will be given brief education on delirium assessment and then complete a family tool based on the Cornell Assessment of Pediatric Delirium (CAPD). This will then be validated against the RN completed CAPD.
In order to also assess the acceptability of family detection of PICU delirium interviews of family members and focus groups of HCP will be conducted using qualitative methodology to determine acceptance and feasibility and to guide future knowledge translation work.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children admitted to 2 PICUs in Canada with an expected length of stay of >/= 48 hours
Key inclusion criteria (6 listed)
- Admitted to Alberta Children's Hospital or McMaster Children's Hospital PICU during study enrollment period
- Anticipated length of stay in PICU >/=48 hours
- Substitute decision maker with the ability to provide informed consent
- Primary caregiver available for CAPD assessments,
- Primary caregiver is defined as the person primarily responsible for the care and upbringing of a child and could include: Parents, designated older sibling, foster parents/guardians, or grandparents, who fulfill this definition. There may be more than one primary caregiver for each child
Key exclusion criteria (2 listed)
- Anticipated discharge/transfer within 24 hours II. Family member unable to understand the instructions for CAPD assessment
- This will be identified by the research assistant in collaboration with the bedside care team. i.e. language/cognitive barrier III. Child in irreversible coma (i.e. persistent vegetative state, RASS -4/SBS -2 or less and not reversible)
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 |
|---|---|---|
| Cornell Assessment of Pediatric DeliriumAlso: State Behavioral Scale, Richmond Agitation and Sedation ScaleCornell Assessment of Pediatric Delirium is a diagnostic test for PICU delirium State Behavioral Scale and Richmond Agitation and Sedation Scale are diagnostic tests for sedation and agitation in children | Diagnostic test | – |
Primary outcome
Validity of delirium screening by caregivers
Time frame: 1-28 days
Evaluate the validity of delirium screening by family or caregivers using the cornel assessment of pediatric delirium on their own children while they are admitted to a PICU
3 secondary outcomes
Healthcare professional acceptability of family administered delirium assessment
Time frame: Up to 1 year
Family/caregiver acceptability of family administered delirium assessment
Time frame: Up to 1 year
Correlation between absolute score of Richmond Agitation and sedation Scale and State Behavioral Scale.
Time frame: 1-28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- 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.
Laurie A. Lee, MN principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by University of Calgary at 2 sites in Canada.
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 6 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Validity of delirium screening by caregivers (time frame: 1-28 days). 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 3 Nov 2022.