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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Remote patient monitoring (RPM) bundle, Telehealth Monitoring, Home Health Monitoring, Remote Health Monitoring?

Research shows that remote patient monitoring (RPM) has improved medical outcomes and care management for chronic conditions like heart failure, and it helps patients manage their health better at home. This suggests that RPM could also be effective for ventilator weaning by providing continuous care and monitoring outside of a hospital setting. ^{1 2 3 4 5}

Is remote patient monitoring generally safe for humans?

Remote patient monitoring (RPM) has been used safely for managing various chronic conditions like heart failure and diabetes, allowing patients to receive care at home. While the studies focus on effectiveness and patient satisfaction, they imply that RPM is a safe method for continuous health monitoring. ^{1 2 3 6 7}

How does remote patient monitoring for ventilator weaning differ from other treatments?

Remote patient monitoring (RPM) for ventilator weaning is unique because it allows continuous care and monitoring of patients in their homes, rather than in a hospital setting. This approach can improve patient engagement and outcomes by using technology to track health data and facilitate communication with healthcare providers, which is different from traditional in-person monitoring methods. ^{1 2 3 6 8}

What is the purpose of this trial?

Some children who are born very early or have other congenital conditions may develop severe, long-term lung problems that make them need to use a breathing machine to live at home. There are no studies that identify the best ways to monitor a home breathing machine or adjust its settings. Increasingly, healthcare systems are using information collected at home to make more informed decisions about a patient's healthcare treatment, which is called "remote patient monitoring". This study will ask whether using remote patient monitoring can provide more complete information to a child's team of doctors, nurses, and respiratory therapists to help a child's healthcare team and family make more informed decisions about a child's home ventilator care. The investigators are hypothesizing it can safely decrease the level of breathing support children need while also avoiding emergency and hospital care and supporting their growth, development, and participation in daily life.

Research Team

Carolyn C Foster, MD, MS

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Early Identification of COVID-19 Infection Using Remote Cardiorespiratory Monitoring: Three Case Reports. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Patient Satisfaction With a Multisite, Multiregional Remote Patient Monitoring Program for Acute and Chronic Condition Management: Survey-Based Analysis. [2023]

3. United States 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). [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Remote Monitoring of Automated Peritoneal Dialysis Improves Personalization of Dialytic Prescription and Patient's Independence. [2019]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. [2023]

7. United States 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. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Development and implementation of a nurse-based remote patient monitoring program for ambulatory disease management. [2023]