Long-term Ventilation at Home
Conditions
Keywords
Home mechanical ventilation, Ventilator assisted individuals, Virtual Intervention
Brief summary
The rising prevalence of ventilator assisted individuals (VAIs) who depend on Home Mechanical Ventilation (HMV) is an escalating public health challenge with important social and economic implications. VAIs are high cost users of the healthcare system, requiring competent healthcare and family caregivers for successful transition to HMV. The TTLive Study will evaluate the effect of a virtual transition intervention delivered through a virtual care platform, compared to usual care on emergent healthcare utilization, caregiver burden, health cost-effectiveness including cost of family caregiver time, and efficiency of clinical encounters for individuals newly transitioning to HMV.
Detailed description
Ventilator Assisted Individuals (VAIs) on HMVs are an ideal population for a virtual care platform that offers a comprehensive bundle of virtual care solutions, sophisticated enough for the complex care demands of this population. A first complex care demand is the challenging clinical follow ups that impose significant financial and medical costs associated with travel to healthcare appointments, and which can predispose these patients to adverse events during travel periods due to an inability to maintain access to some vital technology such as suctioning. A second complex care demand is the multiple transitions in care as some VAIs on HMVs move between and within healthcare sectors due to changing health status or care needs, and multi-morbidity. Formalized handovers between providers are lacking. This results in information gaps and additional and sometimes unnecessary time spent by healthcare providers searching for care plan documentation. A third demand is the lack of timely access to respiratory health professionals experienced in HMV and availability of home follow-up, particularly in the early stages of transition which impedes the transition process. Virtual Care can be defined as any interaction between patients and/or members of their circle of care, occurring remotely, using any form of communication or information technology, with the aim of facilitating or maximizing the effectiveness and quality of patient care. It includes electronic messaging, tele-consultations and tele-monitoring. The advantages of virtual care include the following: 1) enabling the preconditions for truly empowered patients and patient/family-centered care; 2) overcoming the silos of care, and 3) reducing redundancy within the healthcare system by greater knowledge sharing across healthcare sectors. Virtual care provides an opportunity to make healthcare better by overcoming constraints of distance, cost, and time. In TTLive Study, a multi-component platform delivered on an electronic tablet developed for complex care management at home is used in partnership with the patient, family and healthcare team to enable the following: 1) virtual home visits; 2) customizable care plans; 3) basic clinical workflows that incorporate reminders, completion of symptom profiles and tele-monitoring, and 4) secure communication via messaging, audio, and video calls. Investigators hypothesize that this virtual transition intervention will reduce emergent healthcare utilization, improve the experience of care, reduce caregiver burden, become more cost-effective than usual care, and enable more efficient use of healthcare provider time.
Interventions
DEVICEaTouchAway™ platform
Participants will receive multi-component Virtual Transition Intervention. The four components of the intervention comprise: (1) routine virtual clinic visits scheduled at the same frequency as usual care; (2) virtual care plan and action plan for respiratory infection/deterioration and management of ventilator issues; (3) remote, weekly and monthly monitoring of ventilator and cough assist metrics, VAI symptoms, and oxygen saturations; and (4) as needed clinical consultations triggered by identification of abnormal parameters or requested by the VAI or family caregiver.
Sponsors
The Hospital for Sick Children
West Park Healthcare Centre
The Ottawa Hospital
Sunnybrook Health Sciences Centre
London Health Sciences Centre
Children's Hospital of Eastern Ontario
McMaster Children's Hospital
Kingston Health Sciences Centre
Aetonix Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The research coordinator that is consenting the patient and doing the intervention allocation will be different than the research coordinator assessing the outcomes. The outcomes assessor will remain blinded as to whether the participant has received the intervention or not
Intervention model description
Multicenter, prospective 12 months, 7-centre, pragmatic, parallel group, randomized controlled trial with 1:1 allocation of individuals (children and adults) newly transitioning to Home Mechanical Ventilation (HMV) in Ontario that compares a virtual transition intervention to usual care provided by specialist HMV programs.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Participant Eligibility Criteria Inclusion Criteria: i. Individuals newly initiated (in-hospital or as an outpatient) on a ventilator for HMV prescribed by a participating ventilation program in the previous two months. ii. Reads, writes and understands English if does not have a caregiver than can do so. iii. Provides informed consent.
Exclusion criteria
i. Projected life expectancy of ≤ 2 months. ii. Significant cognitive impairment and absence/inability of a family caregiver to use aTouchAway™ or complete questionnaires. iii. Uncontrolled psychiatric illness. iv. No internet access (SIM cards and data costs will be covered by the project budget). v. Currently enrolled in a research study to evaluate another eHealth platform or care coordination. vi. Plans to move outside of Ontario within the next 12 months. Caregivers Eligibility Criteria Caregiver Inclusion Criteria: i. Primary caregiver of an individual newly initiated (in-hospital or outpatient) on a ventilator for HMV prescribed by a participating clinic in the previous two months; ii. Reads, writes and understands English; and iii. Provides informed consent. Eligibility Criteria for the Qualitative Interviews Investigators will exclude those participants: i. Unable to communicate verbally for the duration of an interview Inclusion Criteria for Healthcare Providers in the Circle of Care for the Intervention Group Healthcare provider of an individual from a participating centre i. Use of the aTouchAway for at least five participant encounters ii. Provides informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ED Visits: ED visit rates at 12 months determined using health administrative databases | 12 months± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| To measure caregiver reported sense of mastery (Pearlin Mastery Scale; scores range up to 28, higher scores = higher mastery), if no caregiver available then patient reported sense of mastery will be utilized | 12 months± 4 weeks | To measure caregiver reported sense of mastery, an outcome that is often linked to patient empowerment using the Pearlin Self-Mastery Scale, if no caregiver available then patient reported sense of mastery will be utilized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospital admissions and days in hospital over 6 months using health administrative databases. | 6 months± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Number of hospital admissions and days in hospital over 12 months using health administrative databases. | 12 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Hospital free survival using health administrative data at 6 months. | 6 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Hospital free survival using health administrative data at 12 months. | 12 Months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Time to first ED visit and first hospital admission. | 12 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Overall survival at 6 months. | 6 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Overall survival at 12 months. | 12 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Respiratory and non-respiratory causes of death at 6 months. | 6 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Respiratory and non-respiratory causes of death at 12 months. | 12 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Number and type of outpatient specialist visits at 6 months. | 6 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Number and type of outpatient specialist visits at 12 months. | 12 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Number of family physician visits at 6 months. | 6 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Number of family physician visits at 12 months. | 12 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Homecare service use at 6 months. | 6 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Homecare service use at 12 months. | 12 months ± 4 weeks | Using health administrative databases and the Ambulatory Health Care Record-modified |
| Change in Zarit Burden Interview Score from baseline to 6 months.The 22 items are assessed on a 5-point Likert scale, ranging from 0 = 'never' to 4 = 'nearly always'. | 6 months ± 4 weeks | Caregiver Outcome |
| Change in Zarit Burden Interview Score from baseline to 12 months.The 22 items are assessed on a 5-point Likert scale, ranging from 0 = 'never' to 4 = 'nearly always'. | 12 months ± 4 weeks | Caregiver Outcome |
| Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 6 months | 6 months ± 4 weeks | Health Related Quality of Life Outcome |
| Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 12 months | 12 months ± 4 weeks | Health Related Quality of Life Outcome |
| Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only | 6 months ± 4 weeks | Care Coordination Outcome |
| Incremental Cost Effectiveness Ratios (ICER) of Virtual Transition intervention compared to usual care in improving patient utility from a societal perspective and using a one-year time horizon | 12 months ± 4 weeks | Economic Outcome |
| Mean monthly healthcare costs (public, private and caregiver lost time) over 6 months | 6 months ± 4 weeks | Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified |
| Mean monthly healthcare costs (public, private and caregiver lost time) over 12 months | 12 months ± 4 weeks | Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified |
| Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool | 12 months ± 4 weeks | HealthCare Provider Outcome |
| Process Measure Outcomes | 12 months ± 4 weeks | n(%) of 5 clinic visits conducted virtually as opposed to face to face |
| Process Measure Outcome- Qualitative Interviews | 6 months ± 4 weeks | Qualitative interviews to explore the experience with the aTouchAway intervention by study participants, caregivers and healthcare providers |
| Process Measure Outcome- Site focus Groups | 24 months ± 4 weeks | Our LIVE study data has shown reduction in ED visits due to the pandemic and since ED Visits are the primary outcome for TtLIVE, as a process measure, we will conduct a one-time focus group to generate a hierarchy of important study primary and secondary outcomes with participating sites. Site focus groups: Every participating site will get an opportunity to participate in a 30-60-minute focus group to discuss and rank outcomes relevant to their practice over zoom |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORReshma Amin, MD, MSc
The Hospital for Sick Children
PRINCIPAL_INVESTIGATORLouise Rose, PhD
King's College London
PRINCIPAL_INVESTIGATORAndrea Gershon, MD, MSc
Sunnybrook Health Sciences Centre
Outcome results
None listed