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Trial registered on ANZCTR


Registration number
ACTRN12623000619640
Ethics application status
Approved
Date submitted
15/04/2023
Date registered
6/06/2023
Date last updated
6/06/2023
Date data sharing statement initially provided
6/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting early psychological care in the intensive care unit.
Scientific title
Evaluating the implementation of early psychological care in the intensive care unit: a single-site feasibility and acceptability pilot study (PICUP).
Secondary ID [1] 309463 0
None
Universal Trial Number (UTN)
Trial acronym
PICUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care 329718 0
Critical illness 329719 0
Psychological distress 329720 0
Condition category
Condition code
Mental Health 326614 326614 0 0
Other mental health disorders
Public Health 326843 326843 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to: (1) evaluate the feasibility of implementing early psychological screening and interventions at the time of a patient’s Intensive Care Unit (ICU) admission and; (2) Assess patient and ICU staff acceptability of the novel intervention. The study will have 2 phases: Phase 1 will deliver the psychological intervention to patients in the ICU and assess patient acceptability and; Phase 2 will assess staff acceptability of the intervention implementation.

PHASE 1 – Psychological intervention
Psychological screening - All consenting participants will be administered the Intensive Psychological Assessment Tool, a quick routine screening tool to detect acute psychological distress in ICU.
Stepped psychological care interventions - All identified at-risk participants will then be offered stepped psychological care. Following a hierarchical approach, patients will receive simpler interventions first and progress on to more complex interventions, as informed by patient needs.
Level 1: Participants presenting with normative / sub-thresholds ICU-related psychological distress will be offered psychological first aid, prevention, and monitoring. Participants will be offered basic education regarding common experiences in ICU and associated psychological complaints. Participants will receive information about preventing the onset or worsening of psychological symptoms through the promotion of safety and hope, arousal reduction, and connection with loved ones. This intervention can be administered in 1-2 sessions depending on participant’s tolerance of intervention. The intervention is expected to take between 30 to 60 minutes, depending on the participant's intervention tolerance and/or interfering symptoms (e.g., fatigue, pain), and will be conducted one on one.
Level 2: Participants who present with mild to moderate ICU-related psychological distress will be offered Cognitive Behavioural Therapy (CBT) for acute psychological distress. All participants who score equal or greater than 7 on the IPAT will be offered brief CBT interventions targeting psychological symptoms of concern. There are no recommended number of sessions for CBT as a brief intervention in ICU, and these may be dependent on participant’s treatment goals and length of ICU admission.
Level 3: Participants presenting with severe and persistent mood, anxiety, and trauma related disorders, who are resistant to interventions at Levels 1 and 2, will be offered specialised psychological interventions (e.g., comprehensive suicide/self-harm assessments, safety planning interventions).
The intervention will be delivered by a trained clinical psychologist working in the ICU. The interventions will be offered 48 hours into the patient’s ICU admission and when medically suitable, as determined by medical staff and clinical indicators.
Patient interviews - Interviews will be administered 90-day after hospital discharge, over the phone or videoconferencing. Interviews will last no longer than 60 minutes and will explore participants’ experiences of receiving early psychological care in ICU. Interviews will be conducted by a member of the research team not directly working in the ICU.
Phase 1 is anticipated to occur within 6 to 12 months.

PHASE 2 – Staff acceptability of intervention
Phase 2 will commence once the last participant in phase 1 has been recruited and all data collection timepoints have occurred. ICU clinical staff will be invited to participate in a semi-structured interview aiming to explore their perspectives regarding the implementation of the psychological intervention in ICU. Interviews will be completed in person at the Logan Hospital by a member of the research team not directly working in the ICU. Interviews will take no longer than 40 minutes to complete.
Intervention code [1] 325885 0
Early detection / Screening
Intervention code [2] 325886 0
Rehabilitation
Intervention code [3] 326042 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334478 0
Intervention feasibility will be assessed as a composite of the following measures:
• Time required to recruit to sample target (data from study records)
• Number of eligible participants required to recruit required sample target (data from study records)
• Rate of completion of the intervention (i.e., number of participants who access and complete all aspects of the intervention) (data from study records)
• Number of participants handed over to medical ward psychologist on ICU step-down (data from study records and hospital records)
The study will be deemed feasible if outcomes rates reach at least 80%, and recruitment
occurs within 12 months (data from study records).
Timepoint [1] 334478 0
Once the last recruited participants (N=40) has completed the 90-day post hospital discharge measures/interviews or at 12 months post-commencement of study.
Primary outcome [2] 334479 0
Patient acceptability of intervention:
Data from patient interviews will be coded and analysed through thematic analysis to generate meaningful themes identifying key perceptions, self-reported experience and factors that may contribute to future clinical care design.
Timepoint [2] 334479 0
90 days post hospital discharge.
Primary outcome [3] 334480 0
Staff acceptability of intervention:
Interview data to evaluate current service benefits and issues from the perspective of clinical staff.
A qualitative descriptive approach (Bradshaw et al., 2017) will be used, with the interview guide informed by the Consolidated Framework for Implementation Research (CFIR;
Damschroder et al., 2009). The CFIR analysis framework will be used to code and interpret the interview.

The following data will be collected directly from the participant at the time of the interview:
• Clinician discipline
• Role title
Timepoint [3] 334480 0
Recruitment will commence within 2 weeks of the ICU discharge of the last recruited participant in PHASE 1.
Secondary outcome [1] 420827 0
Feasibility of administering research measure - Hospital Anxiety and Depression Scale (HADS):
Participants will be administered the HADS, a validated 14-item self-rating scale developed to assess symptoms of anxiety and depression in a general medical population of patients (Zigmond and Snaith, 1983). Rate of completion at different timepoints will be used to assess feasibility. Completion of HADS will be tracked in study records.
Timepoint [1] 420827 0
The HADS will be administered three times: (1) within 24 hours of obtaining consent and prior to administering the psychological intervention; (2) prior to hospital discharge; and (3) 90 days post-discharge follow-up contact.
Secondary outcome [2] 420829 0
The following demographics will be collected from medical records:
• Days admitted to ICU
Timepoint [2] 420829 0
At time of ICU discharge
Secondary outcome [3] 420830 0
Patient’s levels of alertness and sedation score between +1 and –1 on the Richmond Agitation Sedation Scale (RASS; Sessler et al, 2002), a standardised assessment tool, as assessed by the treating medical officer and nursing staff.
Timepoint [3] 420830 0
At time of enrolment and at every contact with participant until hospital discharge.
Secondary outcome [4] 420831 0
Patient’s level of consciousness score 15 on the Glasgow Coma Scale Score (GCS; Teasdale & Jennett, 1974), a standardised tool, as assessed by the treating medical officer and nursing staff.
Timepoint [4] 420831 0
At time of enrolment and at every contact with participant until hospital discharge.
Secondary outcome [5] 421724 0
Days admitted to hospital. Data will be collected from the patient's electronic medical records at the time of discharge from hospital.
Timepoint [5] 421724 0
Time of hospital discharge

Eligibility
Key inclusion criteria
Participants - Patients:
• Patient is aged 18 years or greater
• Admitted to the ICU and who are expected to remain in the ICU greater than 48 hours
• Patient’s levels of alertness and sedation score between +1 and –1 on the RASS, as assessed by the treating medical officer and nursing staff at time of enrolment
• Patient’s level of consciousness score 15 on the GCS as assessed by the
treating medical officer and nursing staff at time of enrolment
• English-speaking

Participants - Clinicians:
All ICU clinicians employed in the ICU at the time of recruitment will be eligible to participate
in PHASE 2. Medical, nursing, and allied health clinicians working in the ICU will be invited to
take part in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants - Patients:
• Pre-existing cognitive or intellectual impairment
• Patient’s reason for ICU admission is due to a medical issue directly resulting from a
suicide of self-harm attempt; and/or the patient is identified to be experiencing active
symptoms of psychosis or mania, related to a mental illness, as determined by the
treating medical officer.
• Receiving end-of-life care
• Readmission to ICU within the current hospitalisation
• Previous enrolment in the PICUP study

Participants - Clinicians:
Nil.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a feasibility and acceptability pilot study, a formal sample size calculation is not
required. Published guidance for pilot studies recommend a recruitment target of N = 40
(Lancaster et al., 2004).

PHASE 1 – Feasibility data:
Feasibility descriptive data will be reported against set targets.

PHASE 1 – Patient semi-structured interviews:
Data from the patient interviews will be coded and analysed through thematic analysis to
generate meaningful themes identifying key perceptions, self-reported experience and factors that may contribute to future clinical care design.

PHASE 2 – Clinician semi-structured interviews:
Interviews will be audio recorded and transcribed verbatim. The data from the interviews will be qualitatively reviewed by two members of the PICUP research project and relevant
statements will be coded using the CFIR framework (The Consolidated Framework for
Implementation Research; Damschroder et al., 2009).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/06/2023
Actual
Date of last participant enrolment
Anticipated
17/06/2024
Actual
Date of last data collection
Anticipated
13/09/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 40128 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 313658 0
Hospital
Name [1] 313658 0
Metro South Health Research Support - Study Education and Research Trust Account (SERTA)
Country [1] 313658 0
Australia
Primary sponsor type
Individual
Name
Jessica Hampton
Address
Psychology Department
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook
QLD, 4131
Country
Australia
Secondary sponsor category [1] 315451 0
Individual
Name [1] 315451 0
Prof Elizabeth Ward
Address [1] 315451 0
Centre for Functioning and Health Research
Suite 304, 3rd Floor, Buranda Village
Cnr Cornwall Street and Ipswich Road, BURANDA QLD 4102
Country [1] 315451 0
Australia
Secondary sponsor category [2] 315452 0
Individual
Name [2] 315452 0
Prof Hayden White
Address [2] 315452 0
Deputy Director Intensive Care Unit
Logan Hospital
Cnr Armstrong and Loganlea Rd
Meadowbrook, QLD, 4131
Country [2] 315452 0
Australia
Secondary sponsor category [3] 315453 0
Individual
Name [3] 315453 0
Kellie Sosnowski
Address [3] 315453 0
Nurse Unit Manager Intensive Care Unit
Logan Hospital
Cnr Armstrong and Loganlea Rd
Meadowbrook, QLD, 4131
Country [3] 315453 0
Australia
Secondary sponsor category [4] 315454 0
Individual
Name [4] 315454 0
Lynette Morrison
Address [4] 315454 0
Research Coordinator Intensive Care Unit
Logan Hospital
Cnr Armstrong and Loganlea Rd
Meadowbrook, QLD, 4131
Country [4] 315454 0
Australia
Secondary sponsor category [5] 315455 0
Individual
Name [5] 315455 0
James Banham
Address [5] 315455 0
Psychology Department
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook
QLD, 4131
Country [5] 315455 0
Australia
Secondary sponsor category [6] 315456 0
Individual
Name [6] 315456 0
Marilia Libera
Address [6] 315456 0
Psychology Department
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook
QLD, 4131
Country [6] 315456 0
Australia
Secondary sponsor category [7] 315457 0
Individual
Name [7] 315457 0
Chanelle Louwen
Address [7] 315457 0
Allied Health
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook
QLD, 4131
Country [7] 315457 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312825 0
Metro South Hospital and Health Service Human Research Ethics Committee (EC00167)
Ethics committee address [1] 312825 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 312825 0
Australia
Date submitted for ethics approval [1] 312825 0
07/02/2023
Approval date [1] 312825 0
24/03/2023
Ethics approval number [1] 312825 0

Summary
Brief summary
With advances in medicine, more people are surviving critical illnesses. The psychological impact of critical illness and intensive care units (ICU) on survivors is considerable. Psychologists have a unique opportunity to contribute to early rehabilitation in ICU. However, there is a need to evaluate whether providing psychological services early in a patient's recovery can be done. The current research aims to study whether implementing a psychology service in the Logan Hospital ICU is feasible and accepted by both patients and staff. Recruited patient participants will be screened for psychological distress using validated measures at different times in their recovery, and they will receive psychological care as required. Evaluation of the implementation of the ICU psychology service will involve collecting feasibility outcomes, the degree to which patients find the model of care acceptable, as well as staff perceptions of the service after its implementation. The current research findings will inform future research regarding the implementation of embedded psychology services within ICU and guide the development of such a service within the Logan Hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126050 0
Ms Jessica hampton
Address 126050 0
Psychology Department
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook, QLD 4131
Country 126050 0
Australia
Phone 126050 0
+61 7 3299 8858
Fax 126050 0
+61 7 3299 8280
Email 126050 0
[email protected]
Contact person for public queries
Name 126051 0
Jessica Hampton
Address 126051 0
Psychology Department
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook, QLD 4131
Country 126051 0
Australia
Phone 126051 0
+61 7 3299 8858
Fax 126051 0
Email 126051 0
[email protected]
Contact person for scientific queries
Name 126052 0
Jessica Hampton
Address 126052 0
Psychology Department
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook, QLD 4131
Country 126052 0
Australia
Phone 126052 0
+61 7 3299 8858
Fax 126052 0
Email 126052 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
Lack of informed consent or ethics approval to share.


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.