Remote Patient Monitoring for Ventilator Weaning

(HOMVent4Kids Trial)

Overseen By Leah Heolscher, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Progressive neuromuscular, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether remote patient monitoring (RPM) can improve care for children who need a ventilator at home. The goal is to determine if this approach reduces the need for breathing support and prevents emergency visits while supporting growth and daily activities. Suitable participants use a breathing machine at home and have a family caregiver involved in their care. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance the quality of life for children on ventilators.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring and adjusting ventilator settings for children using home breathing machines.

What prior data suggests that remote patient monitoring is safe for children on home ventilators?

Research shows that remote patient monitoring (RPM) can safely and effectively manage patient care. Past studies found that RPM improves patient safety and helps people adhere to their treatment plans. It also enhances patients' mobility and ability to perform daily activities. Another study found that RPM systems are generally safe and effective for patients requiring ventilators, offering flexibility to meet various needs. Although specific studies on RPM for children using ventilators at home are lacking, these findings suggest that RPM could be a safe and helpful option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the remote patient monitoring (RPM) bundle for ventilator weaning because it offers a new way to support patients transitioning off ventilators. Unlike traditional methods that rely heavily on in-person assessments, RPM enables continuous, real-time monitoring of patients' vital signs and respiratory status from a distance. This approach not only enhances the precision of weaning decisions but also allows for quicker intervention if complications arise, potentially improving patient outcomes and reducing hospital stays. By leveraging technology for real-time data analysis, RPM could revolutionize how ventilator weaning is managed, making it more efficient and patient-friendly.

What evidence suggests that remote patient monitoring is effective for ventilator weaning?

Research has shown that remote patient monitoring (RPM), which participants in this trial will receive, can effectively manage long-term health issues by providing healthcare teams with continuous information. Studies have found that RPM enhances communication and helps patients better care for themselves, leading to improved health outcomes. For patients using breathing machines at home, telemonitoring—a key component of RPM—has shown promise in improving care both at the start and during ongoing treatment. During the COVID-19 pandemic, RPM successfully monitored patients at home who required oxygen. These findings suggest that RPM can reduce the need for emergency care while supporting overall health improvement. ^{3 4 5 6 7}

Who Is on the Research Team?

Carolyn C Foster, MD, MS

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for children aged 0-17 who need a ventilator at home and have a caregiver trained in its use. The child must not be off ventilation during the day or turning 18 soon. They shouldn't be moving, transitioning care, in end-of-life care, or have conditions that don't allow reduced support.

Inclusion Criteria

The patient uses invasive mechanical ventilation at home during any portion of the day at time of enrollment.

I am 17 years old or younger.

The patient has at least one family caregiver (parent or other self-identified legal guardian) trained on home ventilator use who is willing to participate.

Exclusion Criteria

I do not need a ventilator to breathe during the day when I am awake.

The patient has planned a transition of care to another institution or move during the planned study period after enrollment.

The patient is living in long-term institution, transitional facility, or not within a stable home setting during the study period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Integration of longitudinal physiologic data and patient-reported outcome measures into routine clinical care to optimize home mechanical ventilation use

4 months

Remote monitoring with regular data reviews

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote patient monitoring (RPM) bundle

Trial Overview The study tests if remote patient monitoring (RPM) can help manage children's home ventilators better by providing detailed data to their healthcare team. It aims to safely reduce breathing support while avoiding emergencies and supporting growth and daily life participation.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Patients receiving the intervention.

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

Remote monitoring (RM) in patients undergoing automated peritoneal dialysis (APD) led to more frequent modifications of APD prescriptions compared to traditional APD, indicating improved personalization of treatment.

Patients using RM had significantly fewer in-person visits for emergencies, suggesting that RM enhances self-management and efficient use of healthcare resources without compromising the adequacy of dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Monitoring of Automated Peritoneal Dialysis Improves Personalization of Dialytic Prescription and Patient's Independence. Milan Manani, S., Crepaldi, C., Giuliani, A., et al.[2019]

Remote patient monitoring (RPM) significantly reduces hospitalizations for heart failure by 23% and for any cause by 13%, based on a meta-analysis of 21 randomized clinical trials involving 5715 patients.

RPM is cost-effective, saving between €300 to €1000 per patient compared to usual care, while also providing a slight increase in quality-adjusted life years (QALYs), making it a favorable option for heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic impact of remote patient monitoring: an integrated economic model derived from a meta-analysis of randomized controlled trials in heart failure. Klersy, C., De Silvestri, A., Gabutti, G., et al.[2022]

A survey of 3172 patients enrolled in a remote patient monitoring (RPM) program showed that 88.97% felt comfortable managing their health from home, indicating high patient engagement and satisfaction with the program.

93.58% of participants expressed readiness to graduate from the RPM program after meeting their health goals, and 92.76% would recommend RPM to others, demonstrating the program's effectiveness in managing both acute and chronic conditions outside of traditional healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Satisfaction With a Multisite, Multiregional Remote Patient Monitoring Program for Acute and Chronic Condition Management: Survey-Based Analysis. Haddad, TC., Maita, KC., Inselman, JW., et al.[2023]

A retrospective review of 31 patients from the Mississippi Diabetes Telehealth Network Study revealed that African American participants experienced a significant increase in HbgA1c levels after the remote patient monitoring program ended, indicating a higher risk for worsening diabetes management post-intervention.

No other demographic factors, such as income or age, significantly influenced changes in HbgA1c levels, suggesting that targeted strategies may be necessary to support African American patients in maintaining their health outcomes after RPM programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effects of Remote Patient Monitoring in Patients Living with Diabetes: A Retrospective Look at Participants of the Mississippi Diabetes Telehealth Network Study. Davis, TC., Allen, AS., Zhang, Y.[2022]

Remote patient monitoring (RPM) can effectively identify early signs of COVID-19 infection in patients with chronic respiratory diseases, as demonstrated in three case reports involving 9 patients out of 1000 enrolled in a monitoring program.

The RPM system, which includes wearable health monitors and a smartphone app, detected physiological changes in patients at different stages of infection, allowing for earlier diagnosis and intervention, highlighting its potential for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Identification of COVID-19 Infection Using Remote Cardiorespiratory Monitoring: Three Case Reports. Polsky, M., Moraveji, N.[2021]

The ETAPES funding program in France, initiated in 2016 and operational since 2018, supports remote patient monitoring (RPM) specifically for patients with chronic heart failure (CHF) who are at medium or high risk of re-hospitalization, emphasizing the importance of patient education and training in this model of care.

The Satelia® RPM solution focuses on symptomatic monitoring, allowing patients to report their health status through simple questionnaires rather than relying on connected devices, which may enhance patient engagement and ease of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia® Cardio). Pages, N., Picard, F., Barritault, F., et al.[2022]

Remote patient monitoring (RPM) is a practical tool for tracking physical activity in outpatient care, providing more reliable data than self-reports, as demonstrated in four pilot studies across various medical specialties.

RPM can enhance the management of chronic diseases and rehabilitation by offering clinicians objective feedback on patient progress, although attention must be given to ensure all populations can access these digital health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. McCarthy, M., Jevotovsky, D., Mann, D., et al.[2023]

The Mayo Clinic's nurse-led remote patient monitoring (RPM) program has successfully supported nearly 22,000 patients, leading to significantly lower rates of hospitalization, ICU admissions, and mortality among those engaged with the program, particularly during the COVID-19 pandemic.

Patients with chronic conditions who utilized RPM after hospital discharge had a reduced likelihood of 30-day readmissions, demonstrating the program's efficacy in improving patient outcomes and satisfaction, with 95% of participants likely to recommend it to others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and implementation of a nurse-based remote patient monitoring program for ambulatory disease management. Coffey, JD., Christopherson, LA., Williams, RD., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10074164/

The role of telemonitoring in patients on home mechanical ... Telemonitoring is a promising method to improve home mechanical ventilation care, both during initiation and the follow-up period.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10730976/

Benefits and Challenges of Remote Patient Monitoring as ... Common benefits included continuous monitoring of patients to provide prompt care, improvement of patient self-care, efficient communication, increased patient ...

3. nursing.jmir.org nursing.jmir.org/2024/1/e44580/

Remote Patient Monitoring at Home in Patients With COVID-19 Background: During the pandemic, health care providers implemented remote patient monitoring (RPM) for patients experiencing COVID-19.

4. healthsnap.io healthsnap.io/remote-patient-monitoring-patient-outcomes-data-in-2023/

Remote Patient Monitoring: Patient Outcomes Data in 2023 HealthSnap's Remote Patient Monitoring program continues to deliver impactful results, reaffirming its pivotal role in chronic disease management.

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1255798/full

Digital health for remote home monitoring of patients with ... Our study confirms the safety of home remote monitoring of patients with COVID-19 who require oxygen, as well as our literature review.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11258279/

A systematic review of the impacts of remote patient ... RPM interventions demonstrated positive outcomes in patient safety and adherence. RPM interventions also improved patients' mobility and functional statuses.

7. publications.ersnet.org publications.ersnet.org/content/erj/48/3/648

Tele-monitoring of ventilator-dependent patients Many remote health monitoring systems are available, ensuring safety, feasibility, effectiveness, sustainability and flexibility to face different patients' ...