Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001038583
Ethics application status
Approved
Date submitted
31/07/2024
Date registered
28/08/2024
Date last updated
28/08/2024
Date data sharing statement initially provided
28/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-intensive care allied health clinic for Intensive Care Survivors.
Scientific title
Evaluate the feasibility of an allied health-led follow-up service to enhance recovery for intensive care survivors.
Secondary ID [1] 312636 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 334594 0
Post Intensive Care Syndrome 334595 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331188 331188 0 0
Other physical medicine / rehabilitation
Public Health 331189 331189 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
The intervention to be provided is an allied health (AH)-led follow-up service. Participants randomised to the intervention will be triaged based on discipline-specific screening tools for follow-up care from one (or more) of three AH disciplines: Dietetics, Physiotherapy and Psychology, as above. All patients will be contacted via telephone within one month of hospital discharge and baseline health related quality of life will be assessed using the EQ-5D-5L. Additionally the discipline specific screening tools will be done: Mini-Nutritional Assessment-Short Form for dietetics, Barthel Index for Activities of Daily Living for physiotherapy and Hospital Anxiety and Depression Scale and the Impact of event scale-revised tool will be used for psychology.
The intervention will be provided from one-month post-hospital discharge, to up to six months post-hospital discharge. The intervention will be delivered face-to-face where possible (particularly the initial appointment with each discipline), with the option to receive the service via telehealth where required/preferred. The frequency and duration of the sessions will vary between 30 minute and one-hour sessions at clinician discretion with a maximum of 3 sessions per discipline overall.
In each session, personalised strategies to address Post Intensive Care Syndrome (PICS) symptoms will be devised with patients and their families (as appropriate). Dieticians will discuss nutritional plans with participants and may prescribe meal plans, meal supports and supplements. Physiotherapists will discuss training goals with participants and may prescribe an aerobic and strength training program based on this. Psychologists will assess specific patient goals and may use brief skills-based interventions to support patients in self-management techniques to address their goals. Adherence to intervention (% attendance, % completed inter-session work) will be collected and number of intervention sessions attended by mode of delivery (face to face versus telehealth.
Intervention code [1] 329155 0
Rehabilitation
Comparator / control treatment
Usual Care
Participants will receive follow-up at the discretion of the treating medical team and the participants GP as per usual care.
Control group
Active

Outcomes
Primary outcome [1] 338952 0
Feasibility of an AH-led model of care. (Composite primary outcome).
Timepoint [1] 338952 0
6 months post intervention commencement.
Secondary outcome [1] 438020 0
Secondary outcome measures to be evaluated at 6 months post intervention commencement include healthcare utilisation (ED presentations and unplanned hospital admissions).
Timepoint [1] 438020 0
6 months post intervention commencement.
Secondary outcome [2] 438116 0
Physical function
Timepoint [2] 438116 0
Baseline and 6 months post intervention commencement.
Secondary outcome [3] 438117 0
Malnutrition status
Timepoint [3] 438117 0
6 months post intervention commencement.
Secondary outcome [4] 438118 0
Malnutrition Risk
Timepoint [4] 438118 0
Baseline and 6 months post intervention commencement.
Secondary outcome [5] 438119 0
Psychological distress
Timepoint [5] 438119 0
Baseline and 6 months post intervention commencement.
Secondary outcome [6] 438120 0
Post-traumatic stress
Timepoint [6] 438120 0
Baseline and 6 months post intervention commencement.
Secondary outcome [7] 438121 0
Health-related quality of life
Timepoint [7] 438121 0
Baseline and 6 months post intervention commencement.
Secondary outcome [8] 438122 0
Allied health services received from hospital discharge to 6-months.
Timepoint [8] 438122 0
6 months post intervention commencement.

Eligibility
Key inclusion criteria
Inclusion criteria:
- Aged equal to or greater than 18 years of age
- Greater than or equal to 7 day RAH ICU admission
- Discharged to the hospital ward for active care
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
- Not for discharge home
- Non-English speaking persons requiring an interpreter
- Unable to complete questionnaires or attend face to face or telehealth clinic
- Unlikely to survive 6-months as per treating medical team
- For discharge overseas or interstate, and not receiving ongoing healthcare management within the SA Health network.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following informed consent, participants will be randomised to either: 1) usual care or 2) intervention. Allocation will be in a 1:1 fashion via a randomisation schedule developed by a research staff member not involved in patient recruitment, data collection, or data analysis using random.org online random number generator. The schedule will be saved as a password-protected file on the shared hospital server.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A total sample size of 120 (60 per group) meets pilot study recommendations to determine feasibility by estimating outcome variability and event rates with minimal bias and an appropriate level of precision. Initial estimates of group differences in outcomes will be used to inform selection of outcomes for an efficacy trial. Summary statistics will be presented as mean (standard deviation), median [interquartile range] or counts
(percentages). Descriptive statistics will be used to analyse feasibility outcomes of recruitment, attrition and completeness of outcome measure assessment at 6-months (number (%)). Variability of outcomes will be summarised with standard deviations and CIs.
Differences between groups in secondary outcomes including emergency department presentations, unplanned hospital admissions, screening tools (MNA-SF, Barthel Index, HADS, IES-R) and quality of life (EQ-5D-5L) will be assessed using Student’s t-test and Mann-Whitney as appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2024
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
120
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26878 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 42940 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 317071 0
Hospital
Name [1] 317071 0
Intensive Care Unit, Royal Adelaide Hospital
Country [1] 317071 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 319320 0
None
Name [1] 319320 0
Address [1] 319320 0
Country [1] 319320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315819 0
Central Adelaide Local Health Network Health Research Ethics Committee
Ethics committee address [1] 315819 0
Ethics committee country [1] 315819 0
Australia
Date submitted for ethics approval [1] 315819 0
24/04/2024
Approval date [1] 315819 0
03/07/2024
Ethics approval number [1] 315819 0

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

Contacts
Principal investigator
Name 135906 0
A/Prof Lee-anne Chapple
Address 135906 0
Intensive Care Unit, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 135906 0
Australia
Phone 135906 0
+61 8 70741763
Fax 135906 0
Email 135906 0
[email protected]
Contact person for public queries
Name 135907 0
A/Prof Lee-anne Chapple
Address 135907 0
Intensive Care Unit, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 135907 0
Australia
Phone 135907 0
+61 8 70741763
Fax 135907 0
Email 135907 0
[email protected]
Contact person for scientific queries
Name 135908 0
Lee-anne Chapple
Address 135908 0
Intensive Care Unit, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 135908 0
Australia
Phone 135908 0
+61 8 70741763
Fax 135908 0
Email 135908 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be made available upon direct request to the primary investigator and reviewed case-by-case by the management committee.
When will data be available (start and end dates)?
Data will be made available from the time of publication up until 15 years post study commencement in-keeping with data management outlined in the ethics application.
Available to whom?
Anyone will be eligible to apply
Available for what types of analyses?
Scientific analyses
How or where can data be obtained?
Data will not be placed in a public repository but will be directly sent to approved individuals or institutions after consideration of their application to PI Associate Professor Lee-anne Chapple ([email protected]).


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.