MHealth Fairview Masonic Children’s Hospital

Overview of Study: Assist MHealth Fairview Masonic Children’s Hospital on a human-centered research project. This project focused on researching ways to improve a pediatric medical device (CPAP) and the use of the device within the inpatient and outpatient healthcare system.

Participants: 13 participants, including healthcare providers and caretakers within the inpatient and outpatient healthcare systems, took place in focus groups, journey mapping, interviews, and site visits.

Years: 2022-2024

Role(s): Individual Researcher

Impacts:

  • Specified the system-of-use components including the organizations, people, and technology.

  • Mapped multiple journey maps within the inpatient and outpatient healthcare systems.

  • Expanded the knowledge of specific medical device and healthcare system needs and barriers within the inpatient and outpatient healthcare systems.

  • Explored specific areas for opportunities that exist for medical device development and healthcare system innovation.

Pediatric Non-Invasive Ventilation (NIV) Devices are commonly associated with Obstructive Sleep Apnea but are also used to assists with a variety of respiratory disorders, insufficiencies, and failures.

NIVs have different parts (head harnesses, frames, interfaces, elbows, and tubes) that need to work together with a PAP Therapy Device to provide treatment.

Market Analysis:

Current market analysis shows that there are 12 FDA-approved and commercially available NIV devices for pediatric patients.

7 of the 12 pediatric NIV interfaces were nasal masks, 3 were oronasal masks and 2 were total/scuba masks.

Topic:

Problems to Solve:

1

To understand the system-of-use components and process when a pediatric NIV device is implemented within the inpatient and outpatient healthcare systems.

2

To identify the needs and barriers that occur within the inpatient and outpatient healthcare systems when pediatric patients rely on NIV devices.

3

To identify the opportunities for innovation for pediatric NIV devices and within the inpatient and outpatient healthcare systems.

  • Focus Groups

    • Journey Mapping

  • Semi-Structured Interviews

  • Site Visits

    • MHealth Fairview Sleep Clinic

    • Direct Medical Equipment Provider Office

    • Pediatric Department at MHealth Fairview Masonic Children’s Hospital

Research Approach: Qualitative Research

Emily tries a nasal mask!

I tried a nasal mask!

Results: System-of-Use Components

Above: Patient-Centered Map

Above: Hierarchy Map

Results: Customer Journey Maps

Above: Overview of Journey Maps (Escalation, De-escalation, and Outpatient Maps were presented individually)

Device

Availability of NIV Devices

  • There are only 12 pediatric-approved NIV devices currently on the market. However, they are not always available within the inpatient and outpatient healthcare system

  • Many of the available NIV devices have single-sized parts. When multiple sizes are available, there are not enough sizes to accommodate the population

  • The parts are packaged as a bundle/all-in-one size. If a patient needs different sizes for different parts, they may need to purchase an additional pediatric NIV device to accommodate (example: patient may need a small cushion and large harness)

  • Some pediatric NIV devices can only work with Single-circuit or Dual-circuit PAP Therapy Devices, not both. However, there are less Single-circuit PAP Therapy Devices within the inpatient healthcare system, which means they may only be able to use pediatric NIVs that work with Dual-circuit PAP Therapy Devices.

Fit of NIV Devices

  • Specific areas where fit issues were reported: Nasal Bridge, Nose, Cheeks, Ears, Philtrum, Top of Head, Side of Head, Back of Head

Maintenance of NIV Devices

  • Includes switching out devices, assessing skin injuries, cleaning device, and replacing device

Interactions with NIV Devices

  • Sleeping positions differ beyond ‘preferred use’ and issues arise when pediatric patients use these while they are awake

Results: Needs and Barriers

Pathway

Workload Distribution

  • Pediatric Critical Care Nurses, Pediatric Respiratory Therapists, Direct Medical Equipment Provider Team Members, and Caregivers ALL stated they have increased workloads due to the maintenance of the NIV device

Short-term Compliance

  • Insurance coverage ONLY if short-term compliance is achieved, which is 4 or more hours per day for 70% of days over a continuous 30-day period within the first 90 days of receiving the device

  • Short-term compliance is variable depending on patient (may take 3 months or up to a year)

Device

Alternative NIV Parts

Interface

  • Nasal pillows are only available for adult use

  • More alternative interface designs. Many interfaces are designed similarly

Versatile NIV Parts

Head Harness

  • More adaptability with the fit of the head harness, including the ability to switch out the pressure points

  • Quick release of the head harness is crucial for this population

Elbow

  • Single-circuit to Double-circuit adaptability to create more options for the inpatient healthcare providers

  • Being able to position the elbow in different ways would assist pediatric patients during sleep

Custom NIV Parts

Interface and Head Harness

  • Being able to customize parts based on the patients’ needs

Results: Opportunities

Pathway

Workload Distribution

  • Inpatient Healthcare System: Currently they are understaffed within the support and care positions within the inpatient healthcare system needed to keep up with the maintenance of the device. Creating more roles and providing training to others to assist would help with current reported burnout.

  • Outpatient: The outpatient healthcare system is not reimbursed for support and care. Even though they are putting in a lot of effort and energy to get patients to reach compliance.

Short-term Compliance

  • More realistic compliance, with a focus on efficacy instead of time