Home-based Optimization of Mechanical Ventilation in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2025-10-24

Brief Summary

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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.

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Detailed Description

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This is a single-arm, non-randomized, open-label trial using remote patient monitoring for chronic management of invasive home mechanical ventilation in children. The investigators hypothesize that integration of longitudinal physiologic data and patient reported outcome measures into routine clinical care over 4 months can optimize home mechanical ventilation use by 1) reducing the level home mechanical ventilation level of support, 2) improving patient and family quality of life, specifically participation in daily activities and patient's lung symptoms, and 3) improving family-reported shared decision-making and child's access to ventilator care. The investigators will also evaluate its usability within family life and provider workflows and assess early implementation outcomes.

Conditions

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Ventilator Weaning

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Arm

Patients receiving the intervention.

Group Type EXPERIMENTAL

Remote patient monitoring (RPM) bundle

Intervention Type OTHER

Patient-families will be given a "remote patient monitoring (RPM) bundle" with tools to measure objective and subjective information about the child at home that are shared with the home ventilator provider team through an electronic dashboard. The tools include a device to measure carbon dioxide, a digital tablet, a digital weight scale, and a digital application that connects to the child's electronic health record. Each child will be assigned an individualized remote monitoring schedule (timing and data type) based on their indication for ventilation and ventilator regimen at enrollment.

Interventions

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Remote patient monitoring (RPM) bundle

Patient-families will be given a "remote patient monitoring (RPM) bundle" with tools to measure objective and subjective information about the child at home that are shared with the home ventilator provider team through an electronic dashboard. The tools include a device to measure carbon dioxide, a digital tablet, a digital weight scale, and a digital application that connects to the child's electronic health record. Each child will be assigned an individualized remote monitoring schedule (timing and data type) based on their indication for ventilation and ventilator regimen at enrollment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patient uses invasive mechanical ventilation at home during any portion of the day at time of enrollment.
* The patient is 0 to 17 years old.
* 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.
* The primary parental participant reads and speaks either English or Spanish.

Exclusion Criteria

* The patient has progressive neuromuscular or other condition for which decreasing support during the day is not anticipated.
* The patient is already off of ventilation during the day while awake.
* The patient will turn 18 during participation.
* The patient has planned a transition of care to another institution or move during the planned study period after enrollment.
* The patient is in active hospice or similar end-of-life care at time of study enrollment.
* The patient is living in long-term institution, transitional facility, or not within a stable home setting during the study period.

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No