ANZCTR - Registration

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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

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]

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)

Anxiety

Depression

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Anxiety

Mental Health

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]

Not applicable

Comparator / control treatment

No control group - observational study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Incidence of PTSD in ICU survivors

Timepoint [1]

At 3 and 12 months using Post Traumatic Stress Scale (PTSS 14) and Revised Impact of Event Scale (IES-R)

Primary outcome [2]

Incidence of Depression and Anxiety in ICU survivors

Timepoint [2]

At 3 and 12 months using a 21 point Depression Anxiety Stress Scale (DASS 21)

Primary outcome [3]

Incidence of PTSD in family members of ICU survivors

Timepoint [3]

At 3 and 12 months using revised Impact of Event Sale (IES-R)

Secondary outcome [1]

Association between presence of delirium in ICU and psychological outcomes of ICU survivors

Timepoint [1]

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]

Composite outcome: Severity of illness of patient and effect on psychological stress in ICU survivors and their family members

Timepoint [2]

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]

Primary outcome 4: Incidence of Depression and Anxiety in family members of ICU survivors

Timepoint [3]

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?

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]

The Canberra Hospital - Garran

Recruitment hospital [2]

Nepean Hospital - Kingswood

Recruitment hospital [3]

John Hunter Hospital Royal Newcastle Centre - New Lambton

Recruitment hospital [4]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

2605 - Garran

Recruitment postcode(s) [2]

2747 - Kingswood

Recruitment postcode(s) [3]

2305 - New Lambton

Recruitment postcode(s) [4]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Canberra Hospital Private Practice Fund

Address [1]

Canberra Hospital, Yamba Drive, Garran, ACT 2605

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Maurice Sando Foundation Sponsorship Scheme 2015

Address [2]

Acute Care Medicine
Royal Adelaide Hospital Level 5 Eleanor Harrald Building, North Terrace, Adelaide, SA 5000

Country [2]

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]

Individual

Name [1]

Krishnaswamy Sundararajan

Address [1]

Royal Adelaide Hospital ICU,
Robert Gerard Wing, North Terrace, Adelaide, South Australia 5000

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Arvind Rajamani

Address [1]

Intensive Care Unit; Nepean Hospital
Derby St, Kingswood NSW 2747

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Prof Imogen Mitchell

Address [2]

Intensive Care Unit, The Canberra Hospital;
Building 4, Level 1; Yamba Drive; GARRAN ACT 2605

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Manoj Singh

Address [3]

Intensive Care Unit, Canberra Hospital
Building 12; Level 3; Yamba Drive; Garran, ACT 2605

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

A/Prof Rhonda Brown

Address [4]

Research School of Psychology
ANU College of Medicine, Biology and Environment
The Australian National University, Building 39, Science Road, CANBERRA ACT 0200

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

A/Prof Marianne Chapman

Address [5]

ICU, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Prof Frank VanHaren

Address [6]

Canberra Hospital Intensive Care Unit,
Yamba Drive, Garran, ACT 2605

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ACT Health Human Research Ethics Committee

Ethics committee address [1]

Building 10; Level 6; Canberra Hospital
PO BOX 11; Woden, ACT 2606

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/03/2015

Ethics approval number [1]

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

Dr Sumeet Rai

Address

Canberra Hospital Intensive Care Unit
Building 12, Level 3
Yamba Drive, Garran, ACT 2605

Country

Australia

Phone

+61261745707

Fax

[email protected]

Contact person for public queries

Name

Sumeet Rai

Address

Canberra Hospital Intensive Care Unit
Building 12, Level 3
Yamba Drive, Garran, ACT 2605

Country

Australia

Phone

+61261745707

Fax

[email protected]

Contact person for scientific queries

Name

Sumeet Rai

Address

Canberra Hospital Intensive Care Unit
Building 12, Level 3
Yamba Drive, Garran, ACT 2605

Country

Australia

Phone

+61261745707

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
7307	Study protocol					369002-(Uploaded-08-03-2020-07-07-57)-Study-related document.pdf
7308	Informed consent form	Long-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

Source	Title	Year of Publication	DOI
Embase	Long-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.	2019	https://dx.doi.org/10.1136/bmjopen-2018-023310

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically