None listed
Conditions
Brief summary
For people with sleep and breathing problems, wearing a breathing machine and mask (non-invasive ventilation, NIV) when sleeping makes them less sleepy during the day and helps them have a better quality of life. Our team led research showing that using NIV when sleeping reduces the rate of decline in breathing function and can improve the life expectancy in people with Motor Neurone Disease. Motor Neurone Disease (MND) is a rare progressive terminal neurological disease with an average life expectancy of two to five years. The benefits of NIV are relatively largest in MND, but it is believed that all people who need NIV will benefit from its’ use. For patients to receive the greatest benefit from NIV, it is recommended the breathing machine and mask are worn for more than four hours a night. Currently, people with sleep and breathing problems referred to the Victorian Respiratory Support Service are set up with a breathing machine and mask during an admission to the Austin Hospital. These admissions can be burdensome and time consuming for patients, their families and carers. An ever-increasing demand for inpatient beds can also further delay access to NIV and increase burden and anxiety. Once on NIV, troubleshooting usually involves going to the hospital or a nurse from the Victorian Respiratory Support Service Outreach nursing team visiting the patient’s home. Additionally, in light of the coronavirus pandemic (COVD-19), research studies investigating alternative models of care that do not require patients to visit the hospital (telehealth) are needed. In this study we will allocate people to one of two groups (50/50 chance) and each group will receive a different model of care: 1) current model of care (usual care) which involves starting non-invasive ventilation at Austin Hospital or 2) NIV@Home (intervention) which involves starting non-invasive ventilation at home with follow up phone calls from a physiotherapist. We will compare the results to see if the NIV@Home model of care results in similar non-invasive ventilation use.
Interventions
The intervention “NIV@Home” will involve home implementation of non-invasive ventilation (NIV) with remote patient monitoring (tele-monitoring).
A suitable qualified physiotherapist from the specialist NIV service provider will perform the non-invasive ventilation set up and deliver the education in participants' homes. Non-invasive ventilators with cloud-based monitoring software and associated equipment will be provided to participants. Education resources will be standardised across NIV@Hom
The intervention “NIV@Home” will involve home implementation of non-invasive ventilation (NIV) with remote patient monitoring (tele-monitoring). A suitable qualified physiotherapist from the specialist NIV service provider will perform the non-invasive ventilation set up and deliver the education in participants' homes. Non-invasive ventilators with cloud-based monitoring software and associated equipment will be provided to participants. Education resources will be standardised across NIV@Home (intervention) and usual care (control) arms using an information booklet tailored to the participant detailing their equipment list, setup, cleaning and maintenance and relevant clinical contacts. No specific advice will be given to trial participants regarding recommended usage beyond that provided clinically. This advice is provided by treating clinical staff commencing with medical staff at initial discussion about referral, at setup and at clinical review. This typically includes recommendations to “use overnight, or as much as tolerated per day”. Physiotherapy staff will review non-invasive ventilation usage weekly for 12 weeks after home implementation using the cloud-based monitoring software. If non-invasive ventilation usage has averaged less than four hours per night for a week (non-adherent), then initial contact via telephone and/or email will be made to discuss usage and troubleshoot. At this time, all other cloud-based device signals will be made available to the physiotherapist for review to assist with troubleshooting (some or all of the following depending on device; intentional and unintentional leak, pressures, estimated alveolar volume, proportion of ventilator assisted individual breaths). Any non-invasive device alterations that are deemed necessary will be made remotely. A home visit will be conducted if deemed clinically appropriate. In both trial arms, clinical contact or review initiated by the ventilator assisted individual will be managed according to current policies and procedures (initial phone contact followed by Outreach nursing home visits or hospital outpatient attendance or re-admission as required). As in the usual care arm, ventilator assisted individuals will be encouraged to contact the Outreach service as necessary to address any concerns.
Sponsors
Austin Health
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
Adults (aged 18 years and older) referred to the Victorian Respiratory Support Service at Austin Health for initiation of non-invasive ventilation (NIV) deemed clinically suitable by the referring respiratory physician.
Exclusion criteria
Potential participants will be excluded if there is no mobile network coverage in their homes to enable non-invasive ventilation device data uploads, clinical instability, unable to provide informed consent, not proficient in English or unacceptable home visit staff safety risk.
Outcome results
None listed