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Assessing the Feasibility and Acceptability of an Early Psychiatric Assessment after discharge from the Intensive Care Unit.

Early Psychiatric Assessment and Referral Intervention Study (E-PARIS): feasibility and acceptability of Early Psychiatric Assessment and Referral Intervention in adults after ICU discharge

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000894796
Acronym
EPARIS
Enrollment
10
Registered
2022-06-22
Start date
2023-03-09
Completion date
2024-01-18
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Mental illness is unfortunately common after intensive care. A recent large cohort study of 4,943 ICU survivors in the UK found the prevalence of anxiety, depression, and PTSD to be 46%, 40% and 22% respectively, with 18% meeting criteria for all three conditions. At present, while many hospitals operate a post-ICU clinic, there is no agreement in literature as to the best model of care, and to-date the inclusion of a psychiatric assessment has not been evaluated. This study seeks to assess the feasibility and acceptability of including a psychiatric review in addition to standard cares, as well as estimate the effect size this review might have on symptom burden and quality of life to support power calculations for a fully powered RCT if the intervention is deemed both feasible and acceptable.

Interventions

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 ra

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.

Sponsors

Redcliffe Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026