Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000894796
Ethics application status
Approved
Date submitted
18/05/2022
Date registered
22/06/2022
Date last updated
3/08/2022
Date data sharing statement initially provided
22/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Feasibility and Acceptability of an Early Psychiatric Assessment after discharge from the Intensive Care Unit.
Scientific title
Early Psychiatric Assessment and Referral Intervention Study (E-PARIS): feasibility and acceptability of Early Psychiatric Assessment and Referral Intervention in adults after ICU discharge
Secondary ID [1] 307164 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EPARIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ptsd 326371 0
anxiety 326372 0
depression 326373 0
functional impairment 326374 0
Condition category
Condition code
Mental Health 323668 323668 0 0
Anxiety
Mental Health 323669 323669 0 0
Depression
Mental Health 323670 323670 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early Psychiatric Assessment and Referral Intervention
General Assessment (approximately 2 hours in total, including Standard Clinic Cares described below)

Psychiatric review will adhere to a standardised process informed by RANZCP guidelines, as described below.

Patients who provisionally agree to participate will be allocated to attend either when only business-as-usual cares are available, or when the intervention also is available using block randomisation in blocks of 4 or 6, in a 1:1 ratio, with the list generated by the study statistician (AB) and provided in enclosed envelopes to conceal allocation until verbal consent is provided. An appointment time will then be provided, but allocation to treatment or control will remain concealed to the participant at this stage. Patients who choose not to participate will be offered appointment times as per business-as-usual and will not be part of the study.

Participants allocated to the intervention group will attend the clinic on a day and time when the psychiatrist is in attendance. Consenting patients will see the psychiatrist after completing the standard clinical cares described above.

Prior to seeing the participant, the psychiatrist will review the clinical notes pertaining to their premorbid history, and their ICU admission. In addition, the psychiatrist will review the results of the baseline questionnaires, ICU notes and other relevant clinical information. The psychiatrist will discuss these results with the participant and explore how this information interrelates with their premorbid history, and their ICU experience.

The psychiatrist will conduct a comprehensive psychiatric review, including comorbid disorders, substance use, suicidal ideation, psychosocial stressors, social/emotional supports.

Diagnoses of any mental illnesses present will be made based on DSM-V criteria. Psychoeducation will be provided via informal discussion on any new mental illness present, with detail on how this interrelates with their critical illness recovery, and general lifestyle advice will be provided (exercise, healthy eating, sleep hygiene). This discussion will be guided by topics known to be salient to post intensive care recovery as described below, but exact process will be at the discretion of the treating psychiatrist.

Initial treatment for any new mental illness commonly seen in post-ICU populations will be provided as described below.

Management of Anxiety Disorder
Anxiety disorders will be managed according to the Royal Australian and New Zealand College of Psychiatrists guidelines. A brief synopsis is provided below.

Mild Severity – Education provided for Cognitive Behavioural Therapy (CBT), and letter sent to GP to make referral.
Moderate Severity – Referral for CBT as above or Medication* or CBT plus Medication
Severe – CBT plus medication

*As per RANZCP Guidelines Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin and Noradrenaline Reuptake Inhibitor (SNRI) antidepressants will be offered as first line in consultation with patient’s preferences and comorbidities. Where these cannot be utilised, Mirtazapine will also be considered.

Management of Mood Disorder
As with Anxiety disorders, Mood disorders will be managed according to the respective Royal Australian and New Zealand College of Psychiatrists guidelines for Mood Disorders. A brief synopsis is provided below.

Psychological Treatments
Education will be provided on approved psychological treatments for mood disorders:
CBT, Interpersonal Therapy (IPT), Problem-Solving Therapy, Behavioral Activation Therapy, Nondirective Supportive Therapy, and Short-Term Psychodynamic Psychotherapy.

Pharmacological Treatments
Pharmacological treatment will be considered in context with the patient’s medical comorbidities, preferences and prominent mood symptoms. RANZCP guidelines are summarised in the table below.

Prominent Symptom(s) Preferred Medication
Anxiety SSRI/SNRI
Cognitive Difficulties Duloxetine, Vortioxetine
Sleep Disturbance Mirtazapine, Agomelatine
Fatigue Bupropion
Pain Duloxetine, Tricyclic Antidepressant (TCA)
Melancholia TCA

Management of Post-Traumatic Stress Disorder (PTSD)
As with Anxiety disorders and Mood disorders, PTSD will be managed according to the respective Royal Australian and New Zealand College of Psychiatrists guidelines for PTSD, utilising a stepped care approach. A brief synopsis is provided below.

Psychological Treatments
Where indicated, education will be provided on Trauma Focused CBT (TF-CBT), and Eye Movement Desensitisation and Reprogramming (EMDR). Letter sent to GP to make referral for the agreed-on therapy.

Pharmacological Treatments
Pharmacological treatment will be discussed in circumstances where any of the following applies:

• The participant is unwilling or not in a position to engage in or access recommended psychological therapy.
• The participant has a comorbid condition or associated symptoms (e.g., clinically significant depression and high levels of dissociation) where SSRIs are indicated.
• The participant’s circumstances are not sufficiently stable to commence recommended psychological therapy (as a result, for example, of significant ongoing life stress such as domestic violence).
• The participant has not gained significant benefit from recommended psychological therapy.
• There is a significant wait time before psychological treatment is available.

First line medications considered will be SSRIs and SNRIs. Additional medications with evidence for PTSD such as Prazosin and Quetiapine will be considered where appropriate.

Mental Illness not related to ICU presentation
Where a patient has a pre-existing mental illness which is already being managed by their GP or other service, no further intervention will be provided.

Where a new mental illness is identified or suspected, but unrelated to their ICU admission, contact details for relevant services will be provided to the participant and the psychiatrist will notify the patient’s GP of the diagnosis and advise referral for ongoing review and treatment as indicated.

Intervention Follow-up
The Psychiatrist will follow-up all patients where an intervention is initiated 4-6 weeks after their appointment via phone call (~5-10 min, or longer if the participant has clinical concerns they wish to discuss). If there has been least partial clinical response, a letter will be sent to the participant’s GP recommending continuing current cares with ongoing monitoring. If there has been no response or a non-urgent deterioration, a letter will be sent to the GP suggesting referral for ongoing psychiatric review.

Imminent risks
If at clinic assessment the participant appears to require inpatient psychiatric treatment, or there is concern of an imminent risk such as (suicidal ideation with intent and plan), or an urgent clinical deterioration, the participant will be directed to the Redcliffe Emergency Department for immediate review by their local mental health service.

If the imminent risk is identified during the intervention follow-up, the participant will be encouraged to attend their local hospital for urgent review by the mental health service.

Adherence to suggested interventions will be evaluated in the follow-up survey through a structure health service access questionnaire.
Intervention code [1] 323617 0
Early detection / Screening
Comparator / control treatment
Standard Clinic Cares (approximately 1 hour in duration)
As per the Standard Operating Procedure, patients attending the clinic participate in an interview, screening and assessment process followed by the opportunity to provide feedback.

Conducting an Interview
1. ICU admission reviewed to understand context, severity of illness and possible ailments.
2. Patient contacted through face to face, telehealth or telephone appointment.
3. Introduction and purpose of interview

Example: “Thank you for coming in, the clinic runs to provide additional support to patients discharged from ICU. Research is being conducted to help us understand the impact our treatment is having on those surviving ICU admissions.”

4. Gain confirmation to discuss admission details and conduct assessments.
Example: “Do you recall your admission in ICU? Would you like me to explain what occurred?”

If a patient declines and does not wish to talk about admission details, this is respected and staff move onto the assessment phase of the process.

5. Timeline of admission; from origin of admission to discharge. Key points and treatments received (i.e. Intubation, CPR, Medications received, OT, Extubation) are discussed.
6. Assessment form and standardised tools completed (see below):.

Routine Assessments
EQ-5D-5L
HADS
IES-R
Katz index of independence in activities of daily living
Montreal Cognitive Assessment / MOCA – BLIND

Assessment
History
• Electronic medical record and discharge summary reviewed.
• Events surrounding initial presentation used to begin the conversation about admission.
• ICU events such as issues and interventions encountered discussed.
• Staff are respectful of a patient's decision not to revisit their hospital admission in detail.

Assessment
• Assessment of body systems
• Patient asked to self-assess their quality of life and functional ability pre and post ICU
• Further assessment and referral to specialist services considered as appropriate.

Psycho- social
• Social history encompassing pre and post ICU admission
• Questions of relationships, employment, housing, and social interactions. Staff review services that may be able to alleviate additional stress.
• Patient's recollection of their admission explored, mindful that some patients will not remember anything about their time in ICU while others recall vivid memories.
• Acknowledging their feelings and experiences by explaining the prevalence and causes of hallucinations and delusions
• Staff consider possible referral for counselling services.

Feedback (conducted at end of assessment)
• Review current processes.
• Explore services that may be required.
Control group
Active

Outcomes
Primary outcome [1] 331416 0
Feasibility
To address the primary outcome, the Post Appointment Questionnaire is a 7 item self-reported acceptability measure that has been specifically developed for this study. It has been adapted from similar surveys used in previous acceptability studies. Questions focus on whether the participant found their appointment helpful, how confident they feel about managing any psychological symptoms they have or may develop, and how optimistic they feel about their recovery.
Timepoint [1] 331416 0
Immediately post clinic appointment.
Secondary outcome [1] 409771 0
Health Service Utilisation
The Health Services Use Questionnaire will be conducted via phone interview 6 months after their appointment.

It has 11-items and been adapted from a questionnaire utilised in a recent injury vulnerability study. It explores how often the participant has attended a range of clinical, allied health and alternative health services, whether these services were helpful for their mental health, and for those think they needed more help from health professionals than was accessed, the main reason they didn’t get this help.
Timepoint [1] 409771 0
6 months post appointment
Secondary outcome [2] 409772 0
Self Efficacy
The General Self Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life
Timepoint [2] 409772 0
6 months post clinic appointment.
Secondary outcome [3] 409979 0
Employment Status
The Patient Employment Information Questionnaire has been amended from a Questionnaire previously used in epilepsy research and reworded to relate to the patient’s ICU admission. It consists of seven questions around changes to employment and income since their ICU admission.
Timepoint [3] 409979 0
6 months post appointment
Secondary outcome [4] 409980 0
Physical Function
The EQ-5D-5L is a standardised, non-disease specific instrument for measuring health-related quality of life and is validated in a critical care population. It consists of a 5-question questionnaire. The five domains assessed are mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Timepoint [4] 409980 0
6 months post appointment
Secondary outcome [5] 409981 0
Anxiety
The Hospital Anxiety and Depression Scale (HADS) is a questionnaire consisting of two subscales measuring patients’ symptoms of anxiety and depression. Each subscale consists of seven items scored from 0 to 3, resulting in a subscale score range from 0 to 21. A subscale score above 7 suggests clinically significant problems. The questionnaire has been validated among general medical patients as well as critically ill patients.
Timepoint [5] 409981 0
6 months post appointment
Secondary outcome [6] 409982 0
PTSD
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 is a self-report measure that can be completed by patients in a waiting room prior to a session or by participants as part of a research study. It takes approximately 5-10 minutes to complete.
Timepoint [6] 409982 0
6 months post appointment
Secondary outcome [7] 409983 0
Employment Status
The Patient Employment Information Questionnaire has been amended from a Questionnaire previously used in epilepsy research and reworded to relate to the patient’s ICU admission. It consists of seven questions around changes to employment and income since their ICU admission.
Timepoint [7] 409983 0
6 months post appointment
Secondary outcome [8] 411110 0
Depression

The Hospital Anxiety and Depression Scale (HADS) is a questionnaire consisting of two subscales measuring patients’ symptoms of anxiety and depression. Each subscale consists of seven items scored from 0 to 3, resulting in a subscale score range from 0 to 21. A subscale score above 7 suggests clinically significant problems. The questionnaire has been validated among general medical patients as well as critically ill patients. The Hospital Anxiety and Depression Scale (HADS) is a questionnaire consisting of two subscales measuring patients’ symptoms of anxiety and depression. Each subscale consists of seven items scored from 0 to 3, resulting in a subscale score range from 0 to 21. A subscale score above 7 suggests clinically significant problems. The questionnaire has been validated among general medical patients as well as critically ill patients.
Timepoint [8] 411110 0
6 months post appointment

Eligibility
Key inclusion criteria
People discharged from the participating ICU will be eligible to participate if they are:
• Meets the Post-ICU Clinic criteria
o ICU admission >48hrs
o Nil cognitive impairment that prevents participation
• Aged 18 years or over
• Residing in Australia
• Sufficiently fluent in English to complete recruitment and data collection processes
• Able to provide a GP with which the research team can correspond about the intervention
• Likely to be contactable at the 6-month follow-up time
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 6 months
• Unable or unwilling to provide consent to participate for the duration of the study
• Provide consent, but do not provide baseline or 6-month follow-up data
• Unlikely to remain contactable for 6 months after their clinic appointment

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The demographics and results of the Baseline Outcome Measures Bundle will be described using proportions and associated 95% confidence intervals and compared between intervention and control groups to check the integrity of the randomisation.

Responses to the Post Appointment Questionnaire will be assumed to be additive and averaged to produce the primary outcome measure. Differences between groups will be assessed using t-test.

Changes in secondary outcome measures between baseline and 6 months will be compared between intervention and control groups to identify any clinically and statistically significant differences using ANCOVA regression with patients results at baseline fitted as a covariate. The model residuals will be checked to look for outliers and bi-modality. Leave-one-out sensitivity analyses will be used to look for patients that strongly influence the results.

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.

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
Not yet recruiting
Date of first participant enrolment
Anticipated
25/08/2022
Actual
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
19/06/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22392 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 37557 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 311467 0
Hospital
Name [1] 311467 0
Redcliffe Hospital
Country [1] 311467 0
Australia
Primary sponsor type
Hospital
Name
Redcliffe Hospital
Address
Anzac Ave
Redcliffe
QLD 4020
Country
Australia
Secondary sponsor category [1] 312867 0
University
Name [1] 312867 0
University of Melbourne
Address [1] 312867 0
Level 3, Alan Gilbert Building, 161 Barry Street, Carlton VIC 3053
Country [1] 312867 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310936 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 310936 0
Ethics committee country [1] 310936 0
Australia
Date submitted for ethics approval [1] 310936 0
12/04/2022
Approval date [1] 310936 0
13/05/2022
Ethics approval number [1] 310936 0
HREC/2022/QPCH/86123

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

Contacts
Principal investigator
Name 119414 0
A/Prof Dylan Flaws
Address 119414 0
Caboolture Hospital
McKean St
Caboolture QLD 4050
Country 119414 0
Australia
Phone 119414 0
+61 0422379639
Fax 119414 0
Email 119414 0
[email protected]
Contact person for public queries
Name 119415 0
Dylan Flaws
Address 119415 0
Caboolture Hospital
McKean St
Caboolture QLD 4050
Country 119415 0
Australia
Phone 119415 0
+61 7 5433 8888
Fax 119415 0
Email 119415 0
[email protected]
Contact person for scientific queries
Name 119416 0
Dylan Flaws
Address 119416 0
Caboolture Hospital
McKean St
Caboolture QLD 4050
Country 119416 0
Australia
Phone 119416 0
+61 7 5433 8888
Fax 119416 0
Email 119416 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
Some of the survey questions relating to previous trauma are sensitive in nature, and this information will not be shared at the individual participant level to respect privacy and confidentiality.


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
SourceTitleYear of PublicationDOI
EmbaseA protocol for a pilot randomised controlled trial of an Early Psychiatric Assessment, Referral, and Intervention Study (EPARIS) for intensive care patients.2023https://dx.doi.org/10.1371/journal.pone.0287470
N.B. These documents automatically identified may not have been verified by the study sponsor.