None listed
Conditions
Brief summary
Brief summary Bronchiolitis is a common chest infection in infants and some babies need short-term hospital observation in an Emergency Department Short-Stay Unit. This study will test whether selected infants with mild bronchiolitis who need short-stay observation can be safely cared for at home through a virtual Emergency Department Short-Stay Unit model. Infants in the virtual care group will receive hospital-level care at home using wearable monitoring devices that continuously measure oxygen levels, heart rate and breathing rate. They will also receive regular virtual nursing observations, daily paediatrician-led virtual ward rounds and 24-hour access to the virtualKIDS clinical support line. This will be compared with usual care in a physical hospital Emergency Department Short-Stay Unit. The main purpose of the study is to determine whether virtual short-stay care at home is not worse than hospital short-stay care in terms of the need for oxygen treatment within 7 days. The study will also look at safety, hospital re-presentations, length of stay, family and clinician experience, and costs. Study hypothesis We hypothesise that, for carefully selected infants with mild bronchiolitis, virtual Emergency Department Short-Stay Unit care at home with wearable monitoring and regular clinical review will be non-inferior to physical Emergency Department Short-Stay Unit admission, as measured by the need for oxygen therapy within 7 days of randomisation.
Interventions
The intervention is a virtual Emergency Department Short-Stay Unit (EDSSU) admission, delivered as an alternative to physical EDSSU admission for infants with mild bronchiolitis who have been assessed in the Emergency Department as requiring short-stay observation. The intervention provides hospital-level observation and clinical support at home through wearable remote patient monitoring, scheduled audiovisual nursing reviews, daily paediatrician-led virtual ward rounds, 24/7 access to clinical
The intervention is a virtual Emergency Department Short-Stay Unit (EDSSU) admission, delivered as an alternative to physical EDSSU admission for infants with mild bronchiolitis who have been assessed in the Emergency Department as requiring short-stay observation. The intervention provides hospital-level observation and clinical support at home through wearable remote patient monitoring, scheduled audiovisual nursing reviews, daily paediatrician-led virtual ward rounds, 24/7 access to clinical support, and clear escalation pathways back to hospital if required. Care is delivered by the virtualKIDS nursing and medical team, with oversight from paediatricians experienced in paediatric acute care and virtual models of care. The intervention is delivered individually to each participant in their home using audiovisual telehealth, telephone support when required, and continuous wearable remote monitoring. Each infant allocated to the virtual EDSSU arm will be fitted with the Masimo SafetyNet™/Radius PPG™ remote patient monitoring system. The Masimo Radius PPG™ sensor/probe is applied to an appropriate peripheral site according to manufacturer instructions and local clinical training. The device connects to the Masimo SafetyNet™ application and supports remote monitoring of oxygen saturation, heart rate and respiratory rate by the virtualKIDS team. Families are provided with education on device use, probe positioning, troubleshooting, expected observations, and when to contact the virtualKIDS team. A backup Masimo Radius PPG™ probe is provided in case the primary probe fails, dislodges or cannot provide reliable readings. The monitoring system is used continuously for the duration of the virtual EDSSU admission, with alerts and prompts available to parents/carers and clinicians in the virtualKIDS Command Hub. Continuous monitoring is complemented by scheduled 4-hourly reviews, including a full audiovisual assessment by a trained virtualKIDS nurse. These reviews include assessment of heart rate, respiratory rate, oxygen saturation, work of breathing and hydration, aligned with usual paediatric observation and escalation processes. Infants also receive a daily paediatrician-led virtual ward round. The intervention begins after consent, randomisation and allocation to the virtual EDSSU arm, once the infant has been assessed in the Emergency Department as requiring EDSSU-level observation. Monitoring commences when the infant is discharged home under the virtual EDSSU model and continues until the infant is clinically ready for discharge or requires escalation to hospital-based care. A final face-to-face Acute Review Clinic appointment is used for discharge assessment and device removal, unless the infant is escalated earlier for hospital assessment. Parents/carers have 24/7 access to the virtualKIDS clinical support line and may self-escalate at any time if they are concerned. Adherence and safety are supported through parent/carer education, continuous remote monitoring, scheduled 4-hourly clinical reviews, device alerts, backup equipment, a 24/7 support line and predefined escalation criteria. If the device, application, probe, internet connection or audiovisual connection cannot be restored, or if the infant cannot be safely monitored for more than four hours, this is treated as a technology failure and the infant is directed to return for hospital assessment. Remote patient monitoring is used as an enabling technology; the study is evaluating the virtual EDSSU model of care, rather than the device alone. The study will assess whether the virtual EDSSU model is non-inferior to physical EDSSU admission. The primary outcome is the proportion of participants requiring oxygen therapy within 7 days of randomisation. Secondary outcomes include length of stay, ED re-presentation, admission or transfer to physical care, adverse events, technology failure, parent/carer confidence and preparedness, acceptability to families and clinicians, and health-system and family costs.
Sponsors
Sydney Children's Hospital Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
3 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
1. Infant aged 3 months to less than 12 months, corrected age. 2. Presenting to the Emergency Department with mild bronchiolitis, as defined by the PREDICT bronchiolitis guideline. 3. Assessed by the treating Emergency Department doctor as requiring Emergency 4. Department Short-Stay Unit admission for observation. 5. Parent or legal guardian is able to provide written informed consent. 6. Parent or legal guardian is willing for the infant to be randomised to either physical 7. Emergency Department Short-Stay Unit care or virtual Emergency Department Short-Stay Unit care at home. 8. For infants allocated to the virtual care arm, the family must have reliable internet connectivity through wireless or cellular network, and be able to return to hospital for in-person review or escalation if required. 9. For infants allocated to the virtual care arm, the family must be able to attend a final in-person Acute Review Clinic appointment for discharge assessment and device removal.
Exclusion criteria
1. Unclear diagnosis at presentation. 2. Chronic medical condition or other clinical safety concern, including but not limited to congenital heart disease or chronic lung disease. 3. Gestational age less than 37 weeks. 4. Any concern regarding child safety or welfare. 5. Requirement for oxygen supplementation after Emergency Department observation. 6. Requirement for intravenous antibiotics or ongoing nasogastric or intravenous rehydration. 7. Does not live within one hour’s drive of the hospital. 8. Poor or unreliable internet connectivity that cannot be resolved by the study team or the parent/legal guardian, for participants allocated to the virtual care arm. 9. Previously recruited to the study. 10. Practical barriers that cannot be reasonably addressed and would prevent safe home monitoring or timely return to hospital if escalation is required.
Outcome results
None listed