None listed
Conditions
Brief summary
Extracorporeal membrane oxygenation (ECMO) is an advanced life support machine used to support critically ill people with severe heart and/or lung disease. While ECMO can be lifesaving, death during ECMO is common and recovery after this treatment is often slow and difficult, with people facing serious problems with their physical health, memory, mental well-being, and day-to-day functioning. It can also be hard for them and their families to find the right support to help with these issues after hospital discharge. The ECMO-RECOVERY study will test a new intervention to support patients after they leave the hospital following ECMO treatment. This intervention includes use of digital platform (similar to an app) on a mobile phone, tablet or computer and access to a specialised recovery coordinator for regular check-ins through video or phone. Patients will set recovery goals, track their symptoms, and access health information through the app. Their general practitioner (GP) will also receive updates to guide ongoing care. This study will include 227 adult patients who have received ECMO from several hospitals in Australia. Of these patients, roughly half will receive standard care following ECMO, while the other half will receive the ECMO-RECOVERY intervention. We will compare the two groups to see if the intervention helps reduce disability, and improve quality of life, functional status, psychological well-being and cognitive function after ECMO.
Interventions
Adult survivors of ECMO are recruited on the ward and randomised to the intervention or standard care group.
ECMO-RECOVERY intervention
The intervention encompasses virtual contact with a recovery coordinator through the digital platform (app) that includes
-Schedule of 9 virtual visits through video calling from the app (each visit approximately 30 minutes in duration)
-Ability to message the recovery coordinator
-Assistance with setting and monitoring goals during virtual visits
-Access to
Adult survivors of ECMO are recruited on the ward and randomised to the intervention or standard care group. ECMO-RECOVERY intervention The intervention encompasses virtual contact with a recovery coordinator through the digital platform (app) that includes -Schedule of 9 virtual visits through video calling from the app (each visit approximately 30 minutes in duration) -Ability to message the recovery coordinator -Assistance with setting and monitoring goals during virtual visits -Access to tailored educational resources on the app The trial will offer a mix of educational resources developed by relevant peak bodies and bespoke resources developed for the trial. The Recovery Coordinator will assign resources based on the symptom profile of the participant as assessed during each virtual visit. Pre-existing educational resources used are listed below: 1. My Life after ICU: https://www.mylifeaftericu.com/ 2. VECMOS patient resources: https://www.vecmos.org.au/for-patients/ 3. Nutrition resources (PDFs) • Cooking for One, Food Fortification, Protein (Dietitian Connection) • High Protein High Energy Diet (NEMO, Queensland Government, March 2024) 4. Heart failure and Exercise (PDF) – Dr Kate Hayes and Alfred Health 5. Life Lines (PDFs) Topics- Altered Sensation, Anxiety, Breathlessness, Cough, Difficulty sleeping, Dizziness, Fatigue, Flashbacks, Incontinence, Mood, Nausea, Nutrition, Swallowing, Voice change 6. Explain my procedure videos: Topics- ECMO, Ventilation, Induced Coma, Delirium, Recovery after ICU, Swallowing, Voice change, Breathing Recovery, Nutrition 7. Guy’s and St Thomas’ resources: • Critical care recovery website- https://www.criticalcarerecovery.com/ • Video- After having ECMO- Extracorporeal membrane oxygenation (ECMO) - After having ECMO | Guy's and St Thomas' NHS Foundation Trust • PDFs- Voice care after ICU, Sleep hygiene, desensitization program 8. ICU Steps (PDF)- Physiotherapy and Recovery after ICU 9. ICU Digital pathway Patient videos https://youtube.com/playlist?list=PLlEkbSroEPVdiwQmgHOJkiAspAAUXj3L2&si=wRDGlscf9jmIn8jM -Tailored recommendations to support recovery, including feedback of recommendations to the patient's nominated GP, and -Completion of patient-reported outcome measures (PROMs) via the app. If required, the recovery coordinator will offer assistance with PROM completion. The Recovery Coordinator will be a clinical staff member from the hospital where the patient underwent ECMO, e.g., a nurse or a physiotherapist. They will be trained to provide the intervention and equipped with an Operations manual that details the intervention. The digital platform (app) will be provided by Datos Health who will configure its Open Care platform for this trial. The e-platform will allow monitoring elements of intervention delivery via audit trails and logs. Trial monitoring in accordance with a monitoring plan will be undertaken to check protocol deviations and monitor adherence. The Recovery Coordinators will be trained in trial procedures, trial protocol, including specific intervention components e.g., Goal setting. The training will be conducted through site visits and by the CPI and a specialist resource person to cover training on Goal setting and an online 1/2 day workshop 2 weeks before trial commencement. A process evaluation will be undertaken to evaluate the fidelity of the intervention through semi-structured interviews of patients, GPs and Recovery Coordinators, to understand the barriers and facilitators influencing implementation.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who received ECMO in the ICU; 2. Age greater than or equal to 18 years; 3. Patients expected to survive to hospital discharge; 4. Patient enrolled in the EXCEL ECMO registry.
Exclusion criteria
1. Anticipated life expectancy <6 months due to a condition unrelated to ECMO; 2. Patient has a documented pre-existing medical diagnosis of cognitive impairment, e.g., dementia; 3. Unwilling and/or unable to use the website or app version of the e-platform; 4. Patient or Person responsible is unable to provide informed consent; 5. Patient not expected to reside in Australia for 6 months following randomisation; 6. Patient does not have a regular GP or is unable to identify or nominate a GP/primary care practice; 7. Patient received heart and/or lung transplant during their current admission; 8. Patient planned to receive mechanical circulatory support (e.g., ventricular assist device) post-hospital discharge; 9. Patient from Non-English-Speaking Background (NESB) with limited English proficiency that precludes communication with the recovery coordinator 10. Patients with a recovery navigator as part of routine clinical care or research study at the site that provides a similar intervention comprising virtual visits through video calling, goal setting, tailored resources, recommendations and feedback to GPs in addition to PROMs collection.
Outcome results
None listed