None listed
Conditions
Brief summary
ECMO-PROMPT is a trial that focuses on improving the long-term disability, functional status and health outcomes for survivors of ECMO therapy. Providing the results of patient reported outcome measures (PROMs) to patients and their primary care clinicians at hospital discharge and beyond, is an intervention used in other patient groups to support the transition from hospital to home. In this study, ECMO survivors will have PROM monitoring. The intervention group will receive feedback and recommendations.
Interventions
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-Bro
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed