Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000628842
Ethics application status
Approved
Date submitted
10/02/2021
Date registered
26/05/2021
Date last updated
3/04/2023
Date data sharing statement initially provided
26/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tracking Outcomes Post Intensive Care
Scientific title
Tracking Outcomes Post Intensive Care (TOPIC): Incidence of Post intensive care syndrome among patients treated and discharged from Intensive Care Units
Secondary ID [1] 303421 0
None
Universal Trial Number (UTN)
Trial acronym
TOPIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post intensive care syndrome 320712 0
Anxiety 320713 0
Depression 320714 0
PTSD 320715 0
Cognitive Impairment 320716 0
Functional Impairment 320717 0
Condition category
Condition code
Mental Health 318557 318557 0 0
Anxiety
Mental Health 318558 318558 0 0
Depression
Mental Health 318559 318559 0 0
Other mental health disorders
Neurological 318560 318560 0 0
Other neurological disorders
Musculoskeletal 318561 318561 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Discharged from a participating ICU
- Participants contacted via preferred method (telephone, email, post) at 6 weeks and 6 months post ICU discharge.
- At both timepoints, participants complete validated self-reported measures for physical & cognitive function, as well as depression, anxiety and PTSD symptoms.
- A retrospective electronic medical record audit is conducted for all participants that complete at least 6 week follow-up measures described above.

- The medical record audit will collect demographic information, presenting complaint, ICU length of stay, APACHE score, Charlston Comorbidity Index, results of delirium screening measures, as well as hospital codes for icu complications as well as readmissions between the date of discharge, and the date 6 month follow-up was due.
Intervention code [1] 319726 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326515 0
Composite primary outcome "6 week Post Intensive Care Syndrome":

Clinically significant scores on any of the following:
SF36v2
PROMIS - Cognitive
Hospital Anxiety and Depression Scale
Trauma Screening Questionnaire
EQ5D-5L
Timepoint [1] 326515 0
6 weeks post ICU discharge
Secondary outcome [1] 391744 0
Composite secondary outcome "6 month Post Intensive Care Syndrome":

Clinically significant scores on any of the following:
SF36v2
PROMIS - Cognitive
Hospital Anxiety and Depression Scale
Trauma Screening Questionnaire
EQ5D-5L
Timepoint [1] 391744 0
6 months post ICU discharge
Secondary outcome [2] 393442 0
Secondary outcome "6 Week Composite Physical Impairment":

Clinically significant scores on any of the following:
SF36v2
EQ5D-5L
Timepoint [2] 393442 0
6 weeks post ICU Discharge
Secondary outcome [3] 393443 0
Secondary outcome "6 Month Composite Physical Impairment":

Clinically significant scores on any of the following:
SF36v2
EQ5D-5L
Timepoint [3] 393443 0
6 Months post ICU discharge
Secondary outcome [4] 393444 0
Secondary outcome "6 Week Cognitive Impairment":

Clinically significant scores on any of the following:
PROMIS - Cognitive
Timepoint [4] 393444 0
6 Weeks post ICU discharge
Secondary outcome [5] 393445 0
Secondary outcome "6 Month Cognitive Impairment":

Clinically significant scores on any of the following:
PROMIS - Cognitive
Timepoint [5] 393445 0
6 Months post ICU discharge
Secondary outcome [6] 393446 0
Secondary outcome "6 Week Anxiety/Depression":

Clinically significant scores on any of the following:
Hospital Anxiety and Depression Scale
Timepoint [6] 393446 0
6 Weeks post ICU discharge
Secondary outcome [7] 393447 0
Secondary outcome "6 Month Anxiety/Depression":

Clinically significant scores on any of the following:
Hospital Anxiety and Depression Scale
Timepoint [7] 393447 0
6 Months post ICU discharge
Secondary outcome [8] 393448 0
Secondary outcome "6 Week PTSD":

Clinically significant scores on any of the following:
Trauma Screening Questionnaire
Timepoint [8] 393448 0
6 Weeks post ICU discharge
Secondary outcome [9] 393449 0
Secondary outcome "6 Month PTSD":

Clinically significant scores on any of the following:
Trauma Screening Questionnaire
Timepoint [9] 393449 0
6 Months post ICU discharge

Eligibility
Key inclusion criteria
People discharged from participating ICUs will be eligible to participate if they are:
• Aged 18 years or over
• Residing in Australia
• Sufficiently fluent in English to complete recruitment and data collection processes (assessed at time of seeking permission to contact 6 weeks post discharge)
• Provide consent to collection of data from their medical records AND at least partial data from questionnaires at 6 weeks post ICU discharge.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients whose life expectancy at discharge is estimated by their clinical team to be less than 12 months
• Age <18 years
• Unable or unwilling to provide consent to participate for the duration of the study
• Provide consent, but do not provide data at 6 weeks post ICU discharge

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The incidence of Post Intensive Care Syndrome (PICS) will be described using proportions and associated 95% confidence intervals, and compared between study sites, and sub-populations, (such as ICU stay <48hrs, planned vs. emergent admission, ventilated vs. non-ventilated).

Variables from the patients’ history, ICU stay and PREM results will be used to derive an algorithm to predict PICS at 6 weeks using logistic regression and recursive partition techniques. This will be repeated for PICS at 6 months. We aim to develop a prediction tool that will have at least 80% specificity.

The sample will be split into a training and test sample to avoid over-fitting and give a realistic estimate of the tool’s prediction accuracy. Two-by-two tables will be created of the predicted and observed PICS, together with statistics on sensitivity, specificity, and negative and positive predictive value. Models will be checked for influential observations and outliers. The results will be reported using the EQUATOR TRIPOD checklist to ensure completeness and transparency.

A subset of responses obtained in the 6 week follow-up will be used to develop a short, self-administered screening tool to identify PICS during early follow-up through sensitivity analysis, selecting the minimal subset of questions that detects most cases of PICS. This will be converted into a self-administered screening tool to be used by ICU patients after discharge to screen for PICS.

The overall characteristics of the sample will be described using summary statistics. This will help inform the generalisability of our results. The number of patients approached and consented will be tabulated, together with the number who dropped out or died.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/12/2020
Date of last participant enrolment
Anticipated
30/12/2022
Actual
1/10/2022
Date of last data collection
Anticipated
13/06/2022
Actual
8/03/2023
Sample size
Target
300
Accrual to date
Final
227
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18692 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 18693 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [3] 18694 0
Caboolture Hospital - Caboolture
Recruitment hospital [4] 22270 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 33130 0
4032 - Chermside
Recruitment postcode(s) [2] 33131 0
4020 - Redcliffe
Recruitment postcode(s) [3] 33132 0
4510 - Caboolture
Recruitment postcode(s) [4] 37432 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 307837 0
Government body
Name [1] 307837 0
Metro North HHS - Collaborative Research Grant
Country [1] 307837 0
Australia
Funding source category [2] 311327 0
Other Collaborative groups
Name [2] 311327 0
Jamieson Trauma Institute
Country [2] 311327 0
Australia
Primary sponsor type
Individual
Name
Dylan Flaws
Address
Caboolture Hospital - Department of Mental Health
McKean St
Caboolture
QLD 4510
Country
Australia
Secondary sponsor category [1] 308545 0
None
Name [1] 308545 0
Address [1] 308545 0
Country [1] 308545 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307838 0
Royal Brisbane and Women's Hospital Ethics Committee
Ethics committee address [1] 307838 0
Ethics committee country [1] 307838 0
Australia
Date submitted for ethics approval [1] 307838 0
18/02/2020
Approval date [1] 307838 0
20/02/2020
Ethics approval number [1] 307838 0
HREC/2020/QRBW/62033

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108686 0
A/Prof Dylan Flaws
Address 108686 0
Caboolture Hospital - Department of Mental Health
McKean St
Caboolture
QLD 4510
Country 108686 0
Australia
Phone 108686 0
+61 0422379639
Fax 108686 0
Email 108686 0
[email protected]
Contact person for public queries
Name 108687 0
Dylan Flaws
Address 108687 0
Caboolture Hospital - Department of Mental Health
McKean St
Caboolture
QLD 4510
Country 108687 0
Australia
Phone 108687 0
+61 0422379639
Fax 108687 0
Email 108687 0
[email protected]
Contact person for scientific queries
Name 108688 0
Dylan Flaws
Address 108688 0
Caboolture Hospital - Department of Mental Health
McKean St
Caboolture
QLD 4510
Country 108688 0
Australia
Phone 108688 0
+61 0422379639
Fax 108688 0
Email 108688 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.