Critical IllnessNCT03777527
PICU Patient Diary
An observational study of Critical Illness, run by McMaster University at 1 site in Canada.
Trial summary
The PICU-Diary study is a prospective single centre pilot study in the Pediatric Critical Care Unit at McMaster Children's Hospital. We will evaluate the impressions of family caregivers and healthcare providers on the PICU Patient Diary, and its acceptability for use in the PICU, using mixed methods. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2019to 30 Jun 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Critically ill patients and their families admitted to the PICU at McMaster Children's Hospital
Who may be able to join
- Consecutive patients admitted to the PICU will be screened for eligibility to participate in the evaluation component of the PICU Diary study
- We will offer a PICU Diary to families of any critically ill children admitted to the PICU for at least 72 hours and who are fluent in the English language
- Eligible patients and their families will be approached for consent to participate, by a member of the investigator team (MB, KC, SB or CC). For those who consent to participate, they will be oriented to the diary and its use.
Who cannot join
- Stay less than 72 hours
- Not fluent in the English language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: My PICU Diary: a Patient Diary for Critically Ill Children
The PICU-Diary study is a prospective single centre pilot study in the Pediatric Critical Care Unit at McMaster Children's Hospital. We will evaluate the impressions of family caregivers and healthcare providers on the PICU Patient Diary, and its acceptability for use in the PICU, using mixed methods. We will assess the feasibility of assessing the impact of a patient diary on PICU outcomes and psychological distress in critically ill children, 1 month following PICU discharge.
Read the detailed description
There is considerable need for research dedicated to exploring interventions to improve the psychological and functional effects of critical care admission on patients and families. Patient diaries are one approach that has been used in several adult critical care groups and has been shown to positively impact patient care by helping patients better understand their illness, acting as a therapeutic tool and debriefing aid, and providing an outlet for caregivers to participate in care plans. However, to date, there is minimal research available in the pediatric population.
The specific objectives of this study are to evaluate the acceptability and impressions of a patient diary as a supportive measure for critically ill children in the PICU. Our secondary objective is to evaluate the feasibility of measuring the impact of a patient diary on psychological distress in critically ill children, following discharge from the PICU.
The purpose of this diary is to support the recovery of critically ill children and their family members by:
- Helping patients understand visually and in written form as age appropriate, what has happened to them during their PICU stay, how ill they were, and in so doing, reduce anxiety and post-traumatic stress symptoms; AND
- Serving as an engagement tool to help families take on an informed, active role in their child's care plan.
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Diary Acceptability
Acceptability of the diary to family members, patients, and healthcare providers in the PICU to determine the perception of impact of the diary on patient recovery. Information collected with surveys and qualitative interviews.
Measured: 1 day
Feasability of measuring psychological well-being
Patient reported outcome measure of psychological well-being after critical illness with Children's Critical Illness Impact Scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start30 Oct 2019
- Primary completion31 Dec 2020
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Choong, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777527
- Sponsor's protocol ID
- 5843
- Status last verified
- Feb 2021
- First submitted
- 13 Dec 2018
- Last updated
- 25 Feb 2021
- 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My PICU Diary: a Patient Diary for Critically Ill Children
- ClinicalTrials.gov ID
- NCT03777527
- Acronym / sponsor ID
- 5843
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 17 Dec 2018 (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 PICU-Diary study is a prospective single centre pilot study in the Pediatric Critical Care Unit at McMaster Children's Hospital. We will evaluate the impressions of family caregivers and healthcare providers on the PICU Patient Diary, and its acceptability for use in the PICU, using mixed methods. We will assess the feasibility of assessing the impact of a patient diary on PICU outcomes and psychological distress in critically ill children, 1 month following PICU discharge.
Detailed description
There is considerable need for research dedicated to exploring interventions to improve the psychological and functional effects of critical care admission on patients and families. Patient diaries are one approach that has been used in several adult critical care groups and has been shown to positively impact patient care by helping patients better understand their illness, acting as a therapeutic tool and debriefing aid, and providing an outlet for caregivers to participate in care plans. However, to date, there is minimal research available in the pediatric population.
The specific objectives of this study are to evaluate the acceptability and impressions of a patient diary as a supportive measure for critically ill children in the PICU. Our secondary objective is to evaluate the feasibility of measuring the impact of a patient diary on psychological distress in critically ill children, following discharge from the PICU.
The purpose of this diary is to support the recovery of critically ill children and their family members by:
- Helping patients understand visually and in written form as age appropriate, what has happened to them during their PICU stay, how ill they were, and in so doing, reduce anxiety and post-traumatic stress symptoms; AND
- Serving as an engagement tool to help families take on an informed, active role in their child's care plan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients and their families admitted to the PICU at McMaster Children's Hospital
Key inclusion criteria (3 listed)
- Consecutive patients admitted to the PICU will be screened for eligibility to participate in the evaluation component of the PICU Diary study
- We will offer a PICU Diary to families of any critically ill children admitted to the PICU for at least 72 hours and who are fluent in the English language
- Eligible patients and their families will be approached for consent to participate, by a member of the investigator team (MB, KC, SB or CC). For those who consent to participate, they will be oriented to the diary and its use.
Key exclusion criteria (2 listed)
- Stay less than 72 hours
- Not fluent in the English language
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
Patient Diary Acceptability
Time frame: 1 day
Acceptability of the diary to family members, patients, and healthcare providers in the PICU to determine the perception of impact of the diary on patient recovery. Information collected with surveys and qualitative interviews.
Feasability of measuring psychological well-being
Time frame: 1 day
Patient reported outcome measure of psychological well-being after critical illness with Children's Critical Illness Impact Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- 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.
Karen Choong, MD principal investigator
McMaster 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 Critical Illness, run by McMaster University at 1 site 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 3 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 25 Feb 2021. 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 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?
Patient Diary Acceptability (time frame: 1 day). The study lists 2 primary outcomes in all. 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 25 Feb 2021.