An interventional study of virtual ward early discharge in Cardiovascular, sponsored by The Leeds Teaching Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by The Leeds Teaching Hospitals NHS Trust · Not applicable, Interventional, and Supportive care
Observational studies have suggested that early discharge (24hrs with follow up virtually by telephone) of patients who are low risk and have had successful treatment following ST elevation myocardial infarction is safe. This has not been tested in a randomised controlled trial. In this trial the study team propose to identify low risk patients and randomise them to usual care or early discharge and follow up virtually by telephone. The primary endpoint would be readmission to hospital or all cause death up to 30 day following the event. If the outcome is positive, the study will assist early discharge of patients, reduce length of stay, potentially improve patient well being and have positive financial implications for the health service
The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 101 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For the standard group and study participants the clinical records will be reviewed to check if any primary or secondary endpoints were met. They will be contacted at 30 days for a telephone consultation after the index event (time from when patient was admitted), and they will be asked to fill in a patient satisfaction questionnaire
Patients who are randomised to the study group will receive a blood pressure monitor and instructions on how to use the device and transfer data to the study team. The study nurses will contact the patient every day for 3 days following their discharge and perform an virtual ward round assessment by telephone (see table). This will determine whether the patient continues to be monitored via the virtual ward, or whether they need to be referred to the clinical team. They will be issued with an emergency contact number out of hours (coronary care unit LGI) and the nursing hub will operate from 8am to 5pm 7 days a week. They will be referred to the community cardiac rehabilitation service whilst on the pathway.
Other: virtual ward early discharge
Patients who are randomised to the study group will receive a blood pressure monitor and instructions on how to use the device and transfer data to the study team. The study nurses will contact the patient every day for 3 days following their discharge and perform an virtual ward round assessment by telephone (see table). This will determine whether the patient continues to be monitored via the virtual ward, or whether they need to be referred to the clinical team. They will be issued with an emergency contact number out of hours (coronary care unit LGI) and the nursing hub will operate from 8am to 5pm 7 days a week. They will be referred to the community cardiac rehabilitation service whilst on the pathway.
30-day all-cause mortality or any rehospitalisation
(time starts at admission of patient). No randomised controlled trials (RCTs) have compared 24-48 hours discharge to \>48 hours discharge in low-risk STEMI patients. To the knowledge there has been a prior meta-analysis included 5 RCTs comparing discharge at 48 to 72 hours versus \>72 hours and this was found to be safe(4). The 30-day event rate of any hospitalisation or all-cause death that was available from 3 RCTs was 31/489 (6.3%) in the routine care arm and 21/515 (4.1%) in the early discharge arm. For a non-inferiority design, assuming an event rate of 6% in the routine care arm and 4% in the very early discharge arm and a non-inferiority margin of 2.5%, 290 patients would be needed in each arm to provide 80% power, at 5% significance level. To allow for approximate 3-4% drop-out rate, it is intended to recruit 600 patients in total
Time frame: 24-48 hours
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The Leeds Teaching Hospitals NHS Trust →