Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000880549
Ethics application status
Approved
Date submitted
27/07/2015
Date registered
24/08/2015
Date last updated
10/03/2020
Date data sharing statement initially provided
10/03/2020
Date results information initially provided
10/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psychological Stress in intensive care survivors
Scientific title
Psychological stress in post intensive care survivors and their family members
Secondary ID [1] 287155 0
Nil known
Universal Trial Number (UTN)
U1111-1172-5960
Trial acronym
PRICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder (PTSD) 295716 0
Anxiety 295881 0
Depression 295882 0
Condition category
Condition code
Mental Health 295994 295994 0 0
Other mental health disorders
Mental Health 295995 295995 0 0
Anxiety
Mental Health 296134 296134 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
3 and 12 month follow up of intensive care survivors and their family members for prevalence of Post Traumatic Stress Disorder (PTSD); depression; anxiety and health related quality of life.
Intervention code [1] 292425 0
Not applicable
Comparator / control treatment
No control group - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295665 0
Incidence of PTSD in ICU survivors
Timepoint [1] 295665 0
At 3 and 12 months using Post Traumatic Stress Scale (PTSS 14) and Revised Impact of Event Scale (IES-R)
Primary outcome [2] 295807 0
Incidence of Depression and Anxiety in ICU survivors
Timepoint [2] 295807 0
At 3 and 12 months using a 21 point Depression Anxiety Stress Scale (DASS 21)
Primary outcome [3] 295808 0
Incidence of PTSD in family members of ICU survivors
Timepoint [3] 295808 0
At 3 and 12 months using revised Impact of Event Sale (IES-R)
Secondary outcome [1] 316578 0
Association between presence of delirium in ICU and psychological outcomes of ICU survivors
Timepoint [1] 316578 0
Reviewing patient records for incidence of delirium using either a positive Confusion Assessment Method for ICU (CAM-ICU) and/or newer antipsychotic use during ICU admission and comparing with the PTSS-14 and DASS-21 scores at 3 and 12 months
Secondary outcome [2] 316579 0
Composite outcome: Severity of illness of patient and effect on psychological stress in ICU survivors and their family members
Timepoint [2] 316579 0
Reviewing patient data for Admission diagnosis, APACHE III scores, length of ventilation, etc AND comparing with extent of psychological stress in survivors and family members at 3 and 12 months using above mentioned tools like PTSS-14, DASS21, IES-R
Secondary outcome [3] 316754 0
Primary outcome 4: Incidence of Depression and Anxiety in family members of ICU survivors
Timepoint [3] 316754 0
At 3 and 12 months using DASS -21 tool

Eligibility
Key inclusion criteria
A) Intubated ICU survivor:
* Age 18 years and older
* Able to consent
* Intubated and mechanically ventilated for more than 24 hours AND ICU stay for more than 72 hours

B) Non intubated ICU survivor:

* Age 18 years and older
* Able to consent
* Not been intubated during current ICU stay
* Received inotropic/vasopressor support and/or non invasive ventilation during ICU stay
* ICU stay for less than 72 hours

Family Members
* Family member (spouse/partner/next of kin/lives with patient normally) of patients with above criteria
* Age 18 years and older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Common criteria
* Background psychiatric history (schizo affective disorders, chronic PTSD)
* Non English Speaking Background (screening tests are validated in English)
* Imminent death/palliative care patient (exclusion as a result of unlikely follow up at 2 months)

ICU patient survivors (additional criteria)
* Suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury.
* Unable to give informed consent prior to hospital discharge.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary aim of the study is to characterise the long term psychological outcomes (affective symptoms) in Australian intensive care survivors and family members. The study investigators performed a power calculation to compare the difference in prevalence between the intubated and non-intubated group. A sample size of 62 patients in the intubated group and 62 in the non-intubated group will provide 80% power to detect a statistically significant difference between the two groups, with an underlying prevalence of post-ICU affective symptom estimate of 30% and 10% in the intubated and non-intubated populations, respectively, using chi-square tests at a significance level of 5%. The estimate rates for the populations was based on literature review. A potential attrition rate of 20% will be used for the 3 and 12 months follow up and hence the study will plan to recruit 150 participants (75 patients and 75 family members) in each of the groups.
The prevalence of affective symptoms in ICU survivors varies widely between studies based on the screening assessment tools. An assumed prevalence of 30% in the study group was based upon a broad literature review. The prevalence of psychological/emotional stress varies in the family members of ICU survivors. The incidence of anxiety, PTSD and depression among family members of ICU survivors is high at the time of the ICU admission of their loved ones, but this decreases post discharge, and is variably quoted between 20 - 40% in various studies. There is no specific literature related to psychological outcomes in non-intubated ICU patients. Australian population prevalence rates for PTSD are approximately 5% and 10% for anxiety and depression. Hence a composite estimate of 10% was used for the non-intubated group.

Statistical analysis plan:
Patient demographic and baseline characteristics in the two patient cohorts will be summarised using means, standard deviations, medians, and 25-75% quartiles for the continuous measures, and frequencies and percentages for categorical measures. ICU patient survivor outcomes (PTSS-14 and DASS-21) at baseline and at 3 and 12 months follow-up will be compared between the groups using a mixed model analysis. A time by group interaction will be tested. Means and standard errors for PTSS-14 and DASS-21 scores for each time period and risk group will be presented and compared. ICU patient family members outcomes using IES-R and DASS-21 will be analysed similarly. The EQ-5D-5L evaluates HRQoL using 5-point intensity rating scales ranging from “none” to “severe”, with high scores indicating severe issues in the domain. Once the total score has been summed, an algorithm will be used to convert the score, consistent with the approach used by the scale authors. Index scores will then be compared to a UK dataset, as advised and confirmed by email correspondence with the EQ-5D-5L authors (EuroQoL group). Multivariate analysis will be used to look for association between ICU survivors and family members. All analysis will be two-tailed, and p-values less than 0.05 will be considered statistically significant. All analyses will be performed using SPSS version 22.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2015
Actual
3/07/2015
Date of last participant enrolment
Anticipated
31/01/2017
Actual
1/05/2017
Date of last data collection
Anticipated
31/05/2018
Actual
31/07/2019
Sample size
Target
300
Accrual to date
Final
327
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA
Recruitment hospital [1] 4104 0
The Canberra Hospital - Garran
Recruitment hospital [2] 4105 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 4107 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [4] 4108 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 10033 0
2605 - Garran
Recruitment postcode(s) [2] 10034 0
2747 - Kingswood
Recruitment postcode(s) [3] 10036 0
2305 - New Lambton
Recruitment postcode(s) [4] 10037 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 291725 0
Hospital
Name [1] 291725 0
Canberra Hospital Private Practice Fund
Country [1] 291725 0
Australia
Funding source category [2] 291727 0
Charities/Societies/Foundations
Name [2] 291727 0
Maurice Sando Foundation Sponsorship Scheme 2015
Country [2] 291727 0
Australia
Primary sponsor type
Individual
Name
Sumeet Rai
Address
Intensive Care Unit, Canberra Hospital
Building 12; Level 3; Yamba Drive; Garran, ACT 2605
Country
Australia
Secondary sponsor category [1] 290402 0
Individual
Name [1] 290402 0
Krishnaswamy Sundararajan
Address [1] 290402 0
Royal Adelaide Hospital ICU,
Robert Gerard Wing, North Terrace, Adelaide, South Australia 5000
Country [1] 290402 0
Australia
Other collaborator category [1] 278550 0
Individual
Name [1] 278550 0
Arvind Rajamani
Address [1] 278550 0
Intensive Care Unit; Nepean Hospital
Derby St, Kingswood NSW 2747
Country [1] 278550 0
Australia
Other collaborator category [2] 278552 0
Individual
Name [2] 278552 0
Prof Imogen Mitchell
Address [2] 278552 0
Intensive Care Unit, The Canberra Hospital;
Building 4, Level 1; Yamba Drive; GARRAN ACT 2605
Country [2] 278552 0
Australia
Other collaborator category [3] 278554 0
Individual
Name [3] 278554 0
Manoj Singh
Address [3] 278554 0
Intensive Care Unit, Canberra Hospital
Building 12; Level 3; Yamba Drive; Garran, ACT 2605
Country [3] 278554 0
Australia
Other collaborator category [4] 278555 0
Individual
Name [4] 278555 0
A/Prof Rhonda Brown
Address [4] 278555 0
Research School of Psychology
ANU College of Medicine, Biology and Environment
The Australian National University, Building 39, Science Road, CANBERRA ACT 0200
Country [4] 278555 0
Australia
Other collaborator category [5] 278556 0
Individual
Name [5] 278556 0
A/Prof Marianne Chapman
Address [5] 278556 0
ICU, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country [5] 278556 0
Australia
Other collaborator category [6] 281232 0
Individual
Name [6] 281232 0
Prof Frank VanHaren
Address [6] 281232 0
Canberra Hospital Intensive Care Unit,
Yamba Drive, Garran, ACT 2605
Country [6] 281232 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293249 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 293249 0
Building 10; Level 6; Canberra Hospital
PO BOX 11; Woden, ACT 2606
Ethics committee country [1] 293249 0
Australia
Date submitted for ethics approval [1] 293249 0
Approval date [1] 293249 0
24/03/2015
Ethics approval number [1] 293249 0
ETH 11.14.315

Summary
Brief summary
A significant proportion of patients who have survived admission to an Intensive Care Unit (ICU) experience long-term psychological consequences that include anxiety, depression and post-traumatic stress disorder (PTSD). A high proportion of family members of ICU patients also present with varying psychological symptoms of anxiety, depression and PTSD.
Currently there are no routine follow ups of psychological well-being of patients discharged from intensive care units in Australia. There are little data from Australia about the incidence of psychological stress in the local population of ICU survivors and family members. Understanding of the incidence of the psychological stress in ICU survivors and their family members could potentially lead to routine assessment of the problem and measures to reduce the incidence.
The primary aim of this multicentre study is to determine and compare the prevalence of affective symptoms in intubated and non-intubated ICU survivors and their family members by screening them for PTSD, anxiety, depression and Health Related Quality of Life (HRQoL) over a 12-month follow up period. The secondary aims of this study are to identify the risk factors for adverse psychological outcomes in ICU survivors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59066 0
Dr Sumeet Rai
Address 59066 0
Canberra Hospital Intensive Care Unit
Building 12, Level 3
Yamba Drive, Garran, ACT 2605
Country 59066 0
Australia
Phone 59066 0
+61261745707
Fax 59066 0
Email 59066 0
[email protected]
Contact person for public queries
Name 59067 0
Dr Sumeet Rai
Address 59067 0
Canberra Hospital Intensive Care Unit
Building 12, Level 3
Yamba Drive, Garran, ACT 2605
Country 59067 0
Australia
Phone 59067 0
+61261745707
Fax 59067 0
Email 59067 0
[email protected]
Contact person for scientific queries
Name 59068 0
Dr Sumeet Rai
Address 59068 0
Canberra Hospital Intensive Care Unit
Building 12, Level 3
Yamba Drive, Garran, ACT 2605
Country 59068 0
Australia
Phone 59068 0
+61261745707
Fax 59068 0
Email 59068 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
No patient consent obtained for sharing individual patient data at the time of study commencement in 2015. The study designs and conduct precedes the introduction of the ICMJE policy for data sharing


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7307Study protocol    369002-(Uploaded-08-03-2020-07-07-57)-Study-related document.pdf
7308Informed consent formLong-term follow-up for Psychological stRess in Intensive CarE (PRICE) survivors: study protocol for a multicentre, prospective observational cohort study in Australian intensive care units. S Rai, R Brown, Frank van Haren, T Neeman, A Rajamani, K Sundararajan, I Mitchell. BMJ Open. 2019 Jan 25;9(1):e023310   369002-(Uploaded-08-03-2020-07-24-33)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLong-term follow-up for Psychological stRess in Intensive CarE (PRICE) survivors: Study protocol for a multicentre, prospective observational cohort study in Australian intensive care units.2019https://dx.doi.org/10.1136/bmjopen-2018-023310
N.B. These documents automatically identified may not have been verified by the study sponsor.