Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000293561
Ethics application status
Approved
Date submitted
5/01/2024
Date registered
21/03/2024
Date last updated
21/03/2024
Date data sharing statement initially provided
21/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient-Reported Outcome Measure Monitoring and Feedback in Critically Ill Patients Who Survive Extracorporeal Membrane Oxygenation (ECMO)
Scientific title
A Pilot Feasibility randomised controlled trial of Patient-Reported Outcome Measure Monitoring and Feedback to Improve Disability and Quality of Life in Critically Ill Patients Who Survive Extracorporeal Membrane Oxygenation (ECMO)
Secondary ID [1] 309106 0
None
Universal Trial Number (UTN)
U1111-1289-1554
Trial acronym
ECMO-PROMPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extracorporeal Membrane Oxygenation (ECMO) 330307 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326153 326153 0 0
Other physical medicine / rehabilitation
Cardiovascular 329408 329408 0 0
Other cardiovascular diseases
Respiratory 329409 329409 0 0
Other respiratory disorders / diseases
Public Health 329513 329513 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both intervention and comparator group will have Patient Reported Outcome Measures (PROMs) performed at hospital discharge by hospital nurses (and within 4 weeks of returning home from inpatient rehabilitation where applicable). Participants will complete the Modified Rankin Scale (mRS), EQ-5D-5L (Euroquol Group), WHO Disability Assessment Schedule (WHODAS 2.0), Barthel Index for Activities of Daily Living (Barthel-ADL) and Montreal Cognitive Assessment (MOCA-BLIND). PROMS will take approximately 30mins to complete

Patients enrolled in the intervention group will have the results of PROMs and any recommendations for follow up, together with general information about ECMO and complications provided to them and and their primary care practitioner (GP). This information will be in addition to any routine correspondence sent at hospital discharge.
Intervention code [1] 325554 0
Early detection / Screening
Comparator / control treatment
Both intervention and comparator group will have Patient Reported Outcome Measures (PROMs) performed at hospital discharge by hospital nurses (and within 4 weeks of returning home from inpatient rehabilitation where applicable). Participants will complete the Modified Rankin Scale (mRS), EQ-5D-5L (Euroquol Group), WHO Disability Assessment Schedule (WHODAS 2.0), Barthel Index for Activities of Daily Living (Barthel-ADL) and Montreal Cognitive Assessment (MOCA-BLIND).

Comparator group participants and their primary care providers will not have PROMs results nor specific correspondence regarding ECMO provided. No direct correspondence from the study team will be sent.
Control group
Active

Outcomes
Primary outcome [1] 334027 0
Number of patients eligible per month

Timepoint [1] 334027 0
Assessed at completion of recruitment via screening log
Primary outcome [2] 337345 0
Proportion of follow ups completed within two weeks of time point
Timepoint [2] 337345 0
Assessed at 2 weeks post hospital discharge and 6 weeks post discharge home from another facility (if applicable), collected via
Primary outcome [3] 337346 0
Proportion of letters mailed within two weeks of follow up
Timepoint [3] 337346 0
Assessed at 2 weeks post hospital discharge and 6 weeks post discharge home from another facility (if applicable)
Secondary outcome [1] 422848 0
Disability (measured by WHODAS 2.0)
Timepoint [1] 422848 0
6 and 12 months post commencement of ECMO, collected via EXCEL Registry
Secondary outcome [2] 422851 0
Functional independence (measured by Barthel-Activities of Daily Living)
Timepoint [2] 422851 0
6 and 12 months post commencement of ECMO, collected via EXCEL Registry
Secondary outcome [3] 422852 0
Cognitive function (measured by MoCA Blind)
Timepoint [3] 422852 0
6 and 12 months post commencement of ECMO, collected via EXCEL Registry
Secondary outcome [4] 422853 0
Health related quality of life (measured by EQ-5D-5L)
Timepoint [4] 422853 0
6 and 12 months post commencement of ECMO, collected via EXCEL Registry
Secondary outcome [5] 422854 0
Degree of disability/dependence (measured by Modified Rankin Score)
Timepoint [5] 422854 0
6 and 12 months post commencement of ECMO
Secondary outcome [6] 422855 0
Mortality
Timepoint [6] 422855 0
6 and 12 months post commencement of ECMO, collected via EXCEL Registry
Secondary outcome [7] 431523 0
Consent rate
Timepoint [7] 431523 0
Assessed at study completion from screening and enrolment logs
Secondary outcome [8] 431524 0
Loss to follow up rate
Timepoint [8] 431524 0
6 and 12 months post commencement of ECMO, collected via EXCEL Registry
Secondary outcome [9] 431525 0
Withdrawn consent rate
Timepoint [9] 431525 0
Assessed at study completion (12 months post commencement of ECMO) via withdrawal form

Eligibility
Key inclusion criteria
1. Received ECMO therapy in ICU for >24 hours;
2. Adults aged 18 years old or more.
3. Expected to survive to hospital discharge;
4. Enrolled in the EXCEL registry.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Documented pre-existing medical diagnosis of cognitive impairment e.g. dementia;
Not expected to reside in Australia for 12 months following randomisation;
No regular GP or unable to identify a primary care practice.
Patient opts out of EXCEL Registry’s long-term follow up
Hospital length of stay >5 months post ECMO commencement

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)
Central randomisation will be performed using a secure study database
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with variable block sizes and stratification by ECMO mode
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
Statistical methods / analysis
A sample size of 40 ECMO survivors has been chosen to demonstrate feasibility of the study intervention.
Baseline data and feasibility outcomes will be summarised by group using means and SDs, counts and proportions, or medians and interquartile ranges as appropriate.
Change in WHODAS score to 6 months will be summarised using means and standard deviations in each group, and compared using paired t-tests. Additional secondary outcomes will be compared using chi-square tests for equal proportion, student t-tests or Wilcoxon rank sum tests in accordance with the underlying distribution of the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2024
Actual
Date of last participant enrolment
Anticipated
15/03/2026
Actual
Date of last data collection
Anticipated
22/03/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24890 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 40540 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 315889 0
Hospital
Name [1] 315889 0
Alfred Health
Country [1] 315889 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road, Melbourne, 3004
Country
Australia
Secondary sponsor category [1] 318035 0
None
Name [1] 318035 0
Address [1] 318035 0
Country [1] 318035 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312533 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 312533 0
Ethics committee country [1] 312533 0
Australia
Date submitted for ethics approval [1] 312533 0
Approval date [1] 312533 0
23/03/2023
Ethics approval number [1] 312533 0

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

Contacts
Principal investigator
Name 125002 0
Ms Jayne Sheldrake
Address 125002 0
Alfred Health, Level 2, 541 St Kilda Rd, Melbourne VIC 3004
Country 125002 0
Australia
Phone 125002 0
+61 3 9076 0700
Fax 125002 0
Email 125002 0
[email protected]
Contact person for public queries
Name 125003 0
Curtis Hopkins
Address 125003 0
Australian and New Zealand Intensive Care Research Centre, Monash University, Level 3 553 St Kilda Rd, Melbourne VIC 3004
Country 125003 0
Australia
Phone 125003 0
+61 3 9903 0343
Fax 125003 0
Email 125003 0
[email protected]
Contact person for scientific queries
Name 125004 0
Dr Lisa Higgins
Address 125004 0
Australian and New Zealand Intensive Care Research Centre, Monash University, Level 3 553 St Kilda Rd, Melbourne VIC 3004
Country 125004 0
Australia
Phone 125004 0
+61 3 9903 0343
Fax 125004 0
Email 125004 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?
IPD and related data dictionaries are available
When will data be available (start and end dates)?
6 months after publication with no end date determined
Available to whom?
Case-by-case basis at the discretion of the Management Committee
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Contact the management committee via Dr Lisa Higgins - [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.