ECMO-PROMPT
A Pilot Feasibility RCT of Patient-Reported Outcome Measure Monitoring and Feedback to Improve Disability and Quality of Life in Critically Ill Patients Who Survive Extracorporeal Membrane Oxygenation
A multi-centre, randomised, controlled, parallel-group, two-sided superiority pilot trial.
Aims:
To determine whether providing early feedback of Patient Reported Outcome Measures (PROMs) to patients and their primary care practitioners at:
- Discharge from hospital (the hospital where the participant was enrolled into ECMO-PROMPT)
- Within 4 weeks following patient discharge from another acute hospital/rehabilitation facility (if applicable)
- 6 months and 12 months following ECMO commencement (through the EXCEL registry long-term follow up)
is a feasible intervention that can be implemented nationally through the EXCEL Registry.
Rationale:
In recent years, the use of extracorporeal membrane oxygenation (ECMO) has doubled in Australia and internationally. ECMO is one of the most advanced types of life-support, temporarily acting as a heart/lung for a patient by replacing carbon dioxide with oxygenated blood whilst the heart/lung recovers. Whilst ECMO therapy is life-saving, data suggests for those patients that do survive ECMO, many are left suffering disability for prolonged periods of time following hospital discharge. ECMO-PROMPT is a trial that focuses on improving the long-term disability, functional status and health outcomes for survivors of ECMO therapy.
PROMs can be thought of as self-reported questionnaires, where participants answer a series of questions relating to their physical and mental state at various points in time. By recording each patient’s PROMs at various time-points, these valid and reliable questionnaires can be fed back to patients and their primary care clinicians for out-of-hospital assessments. The purpose of this is to bring awareness to patients and their treating GP of any abnormalities or early indicators of developing conditions so that the patient can respond and be treated accordingly.
The ECMO-PROMPT pilot study aims to assess whether PROM monitoring and feedback is a feasible intervention for a national rollout, and to see if there is any early indication that PROM monitoring and feedback does in fact improve disability status 6 months following ECMO (when compared to usual care).
Progress:
HREC approval has been obtained and 3-4 sites are expected to participate. The study is yet to commence recruitment. Recruitment is expected to commence in November 2024. A target of 40 participants will be enrolled at sites across Australia.
Trial Registration:
The study has been registered with the Australian New Zealand Clinical Trials Registry: ACTRN12624000293561