Psychological Stress in intensive care survivors

• Register: ANZCTR
• Last refreshed on: 16 March 2020
• Main ID: ACTRN12615000880549
• Date of registration: 24/08/2015
• Prospective Registration: No
• Primary sponsor: Sumeet Rai
• Public title: Psychological Stress in intensive care survivors
• Scientific title: Psychological stress in post intensive care survivors and their family members
• Date of first enrolment: 03/07/2015
• Target sample size: 300
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000880549.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Sumeet Rai

• Name: Dr Sumeet Rai

Key inclusion & exclusion criteria

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

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.


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Anxiety

Mental Health - Other mental health disorders

Mental Health - Depression

Post Traumatic Stress Disorder (PTSD);Anxiety;Depression;
Post Traumatic Stress Disorder (PTSD)
Anxiety
Depression

Intervention(s)

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.

Primary Outcome(s)

Incidence of Depression and Anxiety in ICU survivors[At 3 and 12 months using a 21 point Depression Anxiety Stress Scale (DASS 21)]

Incidence of PTSD in ICU survivors[At 3 and 12 months using Post Traumatic Stress Scale (PTSS 14) and Revised Impact of Event Scale (IES-R)]

Incidence of PTSD in family members of ICU survivors[At 3 and 12 months using revised Impact of Event Sale (IES-R)]

Secondary Outcome(s)

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

Primary outcome 4: Incidence of Depression and Anxiety in family members of ICU survivors[At 3 and 12 months using DASS -21 tool]

Composite outcome: Severity of illness of patient and effect on psychological stress in ICU survivors and their family members[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 ID(s)

Nil known

Source(s) of Monetary Support

Maurice Sando Foundation Sponsorship Scheme 2015

Canberra Hospital Private Practice Fund

Secondary Sponsor(s)

Krishnaswamy Sundararajan

Ethics review

Status: Approved
Approval date: 24/03/2015
Contact:

ACT Health Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 10/03/2020
• Date Completed: 31/07/2019