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
22/11/2024
Date data sharing statement initially provided
21/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
ECMO PROMPT: Patient-Reported Outcome Measure Monitoring and Feedback in Critically Ill Patients Who Survive Extracorporeal Membrane Oxygenation (ECMO)
Scientific title
ECMO PROMPT: 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 authorised research personnel (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). The Lawton-Brody Independant Activities for Daily Living (IADL) will be completed at 4-weeks. 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) at each time point the PROMs are collected. 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 the end date of each time point.
Primary outcome [3] 337346 0
Proportion of letters mailed within two weeks of follow up
Timepoint [3] 337346 0
Assessed at 2 weeks post the end date of each time point.
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
Patient ineligible for Medicare

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
12/12/2024
Actual
Date of last participant enrolment
Anticipated
15/11/2025
Actual
Date of last data collection
Anticipated
15/01/2026
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 hospital [2] 27358 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [3] 27359 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 40540 0
3004 - Melbourne
Recruitment postcode(s) [2] 43448 0
3220 - Geelong
Recruitment postcode(s) [3] 43449 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 317885 0
Charities/Societies/Foundations
Name [1] 317885 0
Australian and New Zealand Intensive Care Foundation
Country [1] 317885 0
Australia
Primary sponsor type
University
Name
Monash University
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
Dr Lisa Higgins
Address 125002 0
Monash University, School of Public Health and Preventive Medicine, 553 St Kilda Road, Melbourne VIC 3004
Country 125002 0
Australia
Phone 125002 0
+61 399030343
Fax 125002 0
Email 125002 0
lisa.higgins@monash.edu
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
curtis.hopkins@monash.edu
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
lisa.higgins@monash.edu

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


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.