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Trial registered on ANZCTR


Registration number
ACTRN12615001079538
Ethics application status
Approved
Date submitted
17/09/2015
Date registered
14/10/2015
Date last updated
25/02/2019
Date data sharing statement initially provided
25/02/2019
Date results provided
25/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient preferences for receiving an early intervention after critical illness to improve psychological recovery
Scientific title
Patient preferences for receiving an early intervention after critical illness to improve psychological recovery
Secondary ID [1] 287493 0
Nil known
Universal Trial Number (UTN)
U1111-1174-5837
Trial acronym
PRINCIPLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 296237 0
Depression 296238 0
Posttraumatic stress symptoms 296239 0
Condition category
Condition code
Mental Health 296508 296508 0 0
Anxiety
Mental Health 296509 296509 0 0
Depression
Mental Health 296510 296510 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive Care Unit (ICU) diary intervention: in addition to standard care participants will receive a narrative account of their clinical condition and progress prepared jointly by the ICU staff and family members throughout the patient’s ICU stay. The ICU diary will be retained by ICU staff when the participant is discharged to the ward and will be provided to the participant when she/he indicates readiness to receive the diary (between five days and three months after ICU discharge). The diary will be given to the patient in the form of a booklet containing narrative text from staff and family members. The patient will be made aware of the diary 5 days post ICU discharge or as soon after as possible when they are in the hospital wards. The diary will be checked for appropriateness prior to being given to the patient. The number of entries will be monitored (as this is a pilot study).

Individualised care intervention: provision of an individualised summary of the ICU experience prepared by ICU staff and based on the User Centred Critical Care Discharge Information. The ICU experience summary will include the following information: reason for ICU admission, date of ICU admission, length of ICU stay, how the patient arrived to the ICU (by ambulance, transferred from another hospital, family member or friend brought them, etc.), discharge location (medical ward, surgical ward, home, etc.) and a summary of the important elements of the patient’s ICU journey such as the patient’s diagnosis, treatments and procedures.
This summary will be given to the participant in hospital after consenting, and when each participant considers he or she is ready to receive the information. Each participant will be followed up with at least one telephone call 2 weeks post hospital discharge. The purpose of the telephone call is to discuss any problems that the patient may be experiencing and attempt to address these. The ICU Registered Nurse or Research Assistant (with training from psychologist) will perform the phone call. Additional strategies that will be available to the participant include a supported visit to ICU, discussion of challenges the participant is currently experiencing, psychological counselling and provision of detailed information outlining additional support options available. The information regarding the additional support options available will be provided as part of the telephone call and individualised written information.
Intervention code [1] 292876 0
Prevention
Comparator / control treatment
Standard treatment: this will incorporate usual practice. Specific information provision or psychological care is extremely limited at Princess Alexandra Hospital ICU and is dependent on individual assessment and referral for specific services. This is usually arranged by the GP post-hospital discharge.
Control group
Active

Outcomes
Primary outcome [1] 296135 0
Hospital Anxiety and Depression Scale (HADS)
Timepoint [1] 296135 0
Prior to hospital discharge, 3 and 6 months after ICU discharge
Primary outcome [2] 296136 0
Posttraumatic Stress Disorder Checklist – Civilian Version 5 (PCL-5)
Timepoint [2] 296136 0
Prior to hospital discharge, 3 and 6 months after ICU discharge
Secondary outcome [1] 317588 0
Patient Health Questionnaire – 9 (PHQ-9) score. The PHQ-9 is a screening instrument that contains 9 questions assessing depression symptoms.
Timepoint [1] 317588 0
5 days after ICU discharge
Secondary outcome [2] 317589 0
Generalized Anxiety Disorder 7-item (GAD-7) score. The GAD-7 is a screening instrument that contains 7 questions assessing anxiety symptoms.
Timepoint [2] 317589 0
5 days after ICU discharge
Secondary outcome [3] 317590 0
Intensive Care Psychological Assessment Tool (IPAT). The IPAT ) is a screening instrument designed to detect acute distress and the risk of future psychological morbidity in critically ill patients so that appropriate interventions can be implemented.
Timepoint [3] 317590 0
5 days after ICU discharge
Secondary outcome [4] 317591 0
Assessment of Intervention Acceptability

Assessment of acceptability: patients and family members will be invited to complete the Assessment of Intervention Acceptability questionnaire that is based on that used Gwadry-Sridhar and colleagues (1) to measure acceptability of information provision. The Assessment of Intervention Acceptability questionnaire has been developed specifically for use in this study. Questionnaires will be mailed at 3 and 6 months for participant to complete.
(1) Gwadry-Sridhar, F., et al., Instruments to measure acceptability of information and acquisition of knowledge in patients with heart failure. Eur J Heart Fail, 2003. 5(6): 783-91.
Interviews to assess acceptability: interviews will be conducted via telephone by the ICU Research Nurse or Research Assistant with participants from each of the relevant groups including patients, family members and clinicians. Themes will be broad, with open-ended questions aimed at exploring perceived benefits and disadvantages of the intervention and associated facilitators and barriers of receiving and using the intervention. Interviews will be audiotaped and transcribed verbatim to enable thematic analysis. Interviews will be carried out at 3 and 6 months after ICU discharge.
Timepoint [4] 317591 0
3 and 6 months after ICU discharge

Eligibility
Key inclusion criteria
Patients: Consecutive patients who meet the inclusion/exclusion criteria will be invited to participate.
Inclusion criteria:
1. ICU patients with expected ICU LOS >48 hours
2. Able to speak and understand English
3. Glasgow Coma Scale (GCS) 14 – 15 prior to leaving ICU
4. Expected survival beyond hospital (in consultation with the ICU clinical team) of at least 1 month

Family members: Family members of the patients who meet the above inclusion criteria will be invited to participate in the study.

Clinicians: Clinicians who care for patients in the intensive care and have been involved in contributing to the ICU diary or the ICU discharge summary will be invited to participate in the study.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Patients who are not able to receive the intervention or be followed up post discharge (e.g. overseas patients, prisoners)
2. Patients with active psychotic impairment of a history of organic impairment

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient participants and/or family members will be approached by the ICU Research Nurse within 48 - 96 hours of ICU admission for initial consent regarding participation in the study. Informed consent will be then be obtained from the patient after discharge from the ICU to the ward.

The purpose of gaining initial consent from the patient (if able) or the family member is to receive an indication of whether the patient is likely to wish to participate in the study. All patients who indicate a likely desire for participation (or have their family members indicate) will have an ICU diary commenced for them and also have an ICU Discharge Summary prepared on their discharge to the ward, however neither of these items will be provided to the patient until after they have consented to participate in the study. Diaries or discharge summaries of those patients who choose not to participate will be disposed of in a secure manner.
Screening for psychological compromise will occur approximately 5 days after ICU discharge and will be performed using the recognised instruments of the Patient Health Questionnaire – 9 (PHQ-9), the Generalized Anxiety Disorder 7-item (GAD-7) scale and the recently developed Intensive Care Psychological Assessment Tool (IPAT).

Patient participants will be allocated to study groups using a partially randomised process based on the results of the screening process and patient preferences. Screening, registering of participants in the web-based randomisation portal and allocation to group based on randomisation will be conducted by the ICU Research Nurse.

Patient participants who are screened as being ‘distressed’ will be offered a choice of the intervention they receive, while patients who are screened as ‘not distressed’ will be allocated to study groups following computer-generated random assignment using a 1:1:1 ratio. This dual process of randomisation will help to ensure that:
-patients who are experiencing psychological distress are not exposed to an intervention that they do not wish to receive
-by having some participants who are randomised to group allocation this will enable assessment of whether the belief in a specific intervention increases the effectiveness of that intervention.

Allocation concealment will be achieved through use of an online randomisation service offered by Griffith University. Blinding of patient participants, family members and healthcare team providers to the intervention is not possible. Research personnel conducting all long term follow-up will be blinded to group allocation, as will those undertaking statistical analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patient participants who are screened as being ‘distressed’ will be offered a choice of the intervention they receive, while patients who are screened as ‘not distressed’ will be allocated to study groups following computer-generated random assignment using a 1:1:1 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size:
Patients: Based on previous studies, we estimate approximately one-third of patient participants will have psychological compromise after critical illness, and that we will retain approximately 75% of participants in the study at 6 months. A final cohort (at 6 months) of 30 patient participants in each group is desired to ensure adequate data for assessment of feasibility, therefore a total sample size of 120 patient participants at enrolment is required. The PAH ICU admitted 659 patients in the 2013/14 year with length of stay >48 hours, therefore recruitment within the time period is feasible.
Family members: a convenience sample of 30 – 40 family members will be sought to complete the acceptability questionnaires with a sub-sample of approximately 20 family members invited to participate in the interviews to provide more detailed data regarding the acceptability of the interventions.
Clinicians: a convenience sample of 20 clinicians will be sought to provide their perspective of the acceptability of the interventions.

Data analysis: Feasibility and acceptability measures will be assessed using descriptive statistics and identification of problematic points in the research process or content of the interventions. Data from the interviews assessing acceptability will be analysed thematically, and will be used to explain and enhance our understanding of acceptability and further refine the interventions. Baseline group comparisons of outcomes will use both instrument scores and frequency of psychological compromise, with relative counts, percentages and odds ratios used to summarise treatment impact and enable calculation of sample size for a future efficacy study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/10/2015
Actual
18/08/2016
Date of last participant enrolment
Anticipated
19/10/2017
Actual
20/03/2018
Date of last data collection
Anticipated
Actual
1/10/2018
Sample size
Target
180
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4356 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 10579 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 292068 0
Government body
Name [1] 292068 0
Queensland Health

Country [1] 292068 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
237 Ipswich Rd, Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 290743 0
University
Name [1] 290743 0
Griffith University
Address [1] 290743 0
170 Kessels Road, Nathan QLD 4111
Country [1] 290743 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293551 0
Metro South Health Service District Human Research Ethics Commitmee
Ethics committee address [1] 293551 0
Ethics committee country [1] 293551 0
Australia
Date submitted for ethics approval [1] 293551 0
11/08/2015
Approval date [1] 293551 0
15/10/2015
Ethics approval number [1] 293551 0
HREC/15/QPAH/535

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

Contacts
Principal investigator
Name 60426 0
Prof Leanne Aitken
Address 60426 0
Nursing Practice Development Unit
Building 15
Princess Alexandra Hospital
Wooloongabba QLD 4012 Australia
Country 60426 0
Australia
Phone 60426 0
+61 (7) 3176 7256
Fax 60426 0
+61 (7) 3176 7356
Email 60426 0
l.aitken@griffith.edu.au
Contact person for public queries
Name 60427 0
Maria Castillo
Address 60427 0
Nursing Practice Development Unit
Building 15
Princess Alexandra Hospital
Wooloongabba QLD 4012 Australia
Country 60427 0
Australia
Phone 60427 0
+61 (7) 3176 7291
Fax 60427 0
+61 (7) 3176 7356
Email 60427 0
isabel.castillo@griffithuni.edu.au
Contact person for scientific queries
Name 60428 0
Maria Castillo
Address 60428 0
Nursing Practice Development Unit
Building 15
Princess Alexandra Hospital
Wooloongabba QLD 4012 Australia
Country 60428 0
Australia
Phone 60428 0
+61 (7) 3176 7291
Fax 60428 0
+61 (7) 3176 7356
Email 60428 0
isabel.castillo@griffithuni.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be made publicly available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
Documents were uploaded by study researchers but have since been removed.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4006Plain language summaryNo The objective of this study was to examine the fea... [More Details]
4572Study results articleYes NOVEMBER 2020 Castillo MI, Mitchell M, Davis C,... [More Details]
4573Other filesNo Aitken LM, Mitchell M, Davis C, Castillo I, Powell... [More Details]

Documents added automatically
No additional documents have been identified.