Economic Study of a Pediatric Tracheostomy Remote Home Monitoring Program (PTRHMP) Compared to Prolonged Hospitalization for Children With Tracheostomy

ABSTRACT

Background/Context

Home health nursing is considered critical to transition to at‐home care after pediatric tracheostomy. This diminishing resource contributes a barrier to at‐home care. Telemedicine (Bluetooth wireless technology for monitoring vital signs, Wi‐Fi data transfer to a centralized monitoring center for alarm response) could add support for families during this transition. This manuscript compares a retrospective evaluation of observed hospital costs to modeled estimates for a Pediatric Tracheostomy Remote Home Monitoring Program (PTRHMP): equipment alarm monitoring, call‐to‐home confirmation, and a centralized database of critical information for Emergency Medical Services (EMS) dispatch.

Key Methods

(1) Cost of Care Cohort analysis of in‐patient cost of care for pediatric tracheostomy patients using retrospective chart review. (2) Modeled cost estimates using a financial proforma developed by experts in the field. (3) Comparative Analysis of Cost of Care Cohort versus PTRHMP proforma. (4) Potentially avoidable Adverse Event analysis.

Results

Thirty‐three candidates met inclusion criteria for the Cost of Care Cohort Analysis. Average LOS was 31.6 days longer than target LOS, was influenced by average number of caregivers (p < 0.0001) and by age at tracheostomy placement (p = 0.038; 1), and averaged ($17,000/day billed, $3000/day payments received) 10 times the cost estimated for the PTRHMP proforma ($285 per patient‐day).

Conclusion

The widespread adoption of a Pediatric Tracheostomy Remote Home Monitoring Program (PTRHMP) appears to be technologically and financially tenable at one tenth the cost of in‐patient care. Patients under the age of 2 at tracheostomy placement may represent a separate subgroup for analysis. An implementation study is required to determine the level of safety compared to currently available conditions.

Level of Evidence

2—Cohort Study.

Pediatric tracheostomy is a life‐ and lifestyle‐changing event for families that enables children with critical airway disorders to develop at home within the family setting that comes at great risk. Harnessing technology for health monitoring and dispatch of first responders to support the caregiver is a currently technologically and financially achievable investment in the provision of quality healthcare.

1. Background

1.1. Introduction

Tracheostomy was invented for acute airway disorders and later popularized as a temporary, in‐hospital means by which to maintain the airway (See Appendix A: “An historical and sociologic review of pediatric tracheostomy”). In 1909, Dr. Chevalier Jackson championed consideration of tracheostomy safety, including candidate and timing selection and surgical skill. Over the last century pediatric tracheostomy been adapted for use to bridge infancy to respiratory independence for children with congenital craniofacial lesions, prematurity at the limits of survival with bronchopulmonary dysplasia and pulmonary hypertension, congenital high airway obstruction syndromes (CHAOS), acquired airway lesions, and/or short‐term ventilator dependence [1] in the critical care unit.

The portable home ventilator was developed in the late 1970s, and a major focus for use was on pediatric care (FDA‐approval for the L3 ventilator outside the hospital, 1977) [1]. Because this level of care remained cost‐prohibitive for many, Ronald Reagan signed the Tax Equity and Fiscal Responsibility Act/TEFRA (P.L. 97‐248) [2] in 1982 to provide financial support for at‐home care of disabled or critically ill children, including the technology‐dependent pediatric tracheostomy patient.

A large expansion of the use of pediatric tracheostomy in the at‐home care setting occurred between 2000 and 2015 as a result of several events [3, 4].

• –Advances in technology resulted in the development and availability of portable home technology for ventilation and oxygen monitoring (See Appendix A for details).
• –Research supported [5, 6], and the American Academy of Pediatrics (AAP) [7] endorsed the child's need for the home psychosocial environment for patient‐centered care as critical to development.
• –Federal healthcare policies shifted to encourage care of chronically ill patients in less‐costly at‐home environments [8, 9, 10, 11].

Between 1980 and2018, the incidence of tracheostomy placement at this institution was 3–5 per year. Between 2018 and2022, this institution ranged between 20 and25 per year, an observed 5‐fold increase in tracheostomy placement. In personal communications with other pediatric medical centers, the same trend has been observed across the nation. Engaging with and training families is time‐consuming, contributing to the length of stay (LOS) after tracheostomy. Few dedicated skilled nursing facilities accommodate children with tracheostomy and mechanical ventilation, and they are not equivalent to a home environment.

Home health nursing has been considered the critical bridge for the successful and safe transition in care. However, home health nursing hours and medical supplies remain costly for many families with tracheostomy‐dependent children [3, 4, 5]. Over the last two decades, the nursing sector has battled attrition, disproportionately within the home health sector [6, 12, 13, 14].

Technological advances including Bluetooth devices, Wi‐Fi data transmission, read‐through‐motion capability, and centralized alarm and data review have entered the durable medical equipment (DME) market. It is proposed that currently available technology is now affordable and widely available to be used to develop a Pediatric Tracheostomy Remote Home Monitoring Program (PTRHMP). This program model aims to support the patient and family during the transition to at‐home as an alternative to lengthy hospitalizations in the intensive care unit. This manuscript compares a retrospective evaluation of observed hospital costs to modeled estimates for a PTRHMP: equipment alarm monitoring, call‐to‐home confirmation, and a centralized database of critical information for Emergency Medical Services (EMS) dispatch.

2. Statement of Objective

The hypothesis is that a PTRHMP is both technologically possible and financially cost‐appropriate as an adjunct for at‐home Caregivers as an alternative to prolonged hospitalization.

3. Methods

1. Cost of Care Cohort Analysis: in‐patient cost of care for pediatric tracheostomy patients using retrospective chart review for hospital‐based billings and payments received and LOS analysis

2. Financial proforma: PTRHMP design and financial analysis completed in consultation with experts in post‐acute respiratory care (Eventa LLC; Livingston, TN)

3. Comparative Analysis: in‐patient billings and payments received versus PTRHMP cost data

4. Potentially Avoidable Adverse Event Analysis: at‐home preventable tracheostomy‐related adverse events were tabulated

A health economic analysis plan was not developed with economists, as this was a study of a proposal to define the costs of the program compared to the costs of prolonged hospitalization; it was not designed as a study of implementation.

3.1. Ethics Statement

The deidentified protected health information analyzed for this project was included in the data collected for the routine development of the tracheostomy registry and its use is incorporated into the existing IRB‐approved institutional data registry and the GTC registry. The financial data were analyzed separately, with a separate IRB‐approved exemption specifically for this work. All data were deidentified for evaluation before analysis was begun.

Every effort was made to adhere to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) throughout the duration of this project. Adherence to these guidelines ensures the transparent, consistent, and methodologically sound reporting of economic evaluations, thereby enhancing the clarity, credibility, and practical relevance of the study's findings. The team committed to providing necessary data and support to facilitate compliance with these standards and to contribute meaningfully to the production of a high‐quality, rigorously conducted evaluation by using the CHEERS 2022 CheckList.

3.2. Cost of Care Cohort—Subject Selection

The setting is a tertiary care free‐standing children's hospital in New Orleans, Louisiana.

The subjects were identified from the institutional data registry, using the following inclusion criteria:

• –Aged 0–18 years
• –Treated with tracheostomy placement (CPT 31600, “tracheostomy,” or CPT 31601, “tracheostomy under 2 years of age”)
• –Surgical tracheostomy and hospitalization were completed within the two‐year period spanning from January 1, 2021, to December 31, 2022

As is standard of care in this institution, all were open surgical tracheostomies (not percutaneous), and all were performed by fellowship‐trained pediatric otolaryngologists. All patients received routine postoperative tracheostomy management by the pediatric otolaryngology service and the respective intensive care service for the first week. They were followed by the multidisciplinary tracheostomy team during all subsequent weeks of the hospitalization, including bedside visits once weekly for full tracheostomy‐related examination and care planning. This was fully documented with standard notes in the EPIC record and catalogued for the GTC and the American College of Surgeons (ACS) database.

Study exclusion criteria were decannulation during this primary hospitalization, death during the hospitalization, and open account (not yet discharged).

Data points included basic demographics (age over or under 2 years at tracheostomy placement, sex assignment at birth, subject's family racial identification, insurance carrier, Child Opportunity Index (COI) for the subject's home address [15], number of trained caregivers, number of siblings, number of siblings under the age of 5 years). The COI was converted from a nominal to an ordinal data set for analysis (scaled 1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high). Additional data collected included the Billed Costs, the Payments Received, and the LOS.

3.3. Cost of Care Cohort—Data Collection

The total cost of care was obtained from the billing and the payment received for each study subject, then the LOS was used to calculate the daily data. The Total Billings and Billings per Subject‐Day and the Total Payments Received and Payments Received per Subject‐Day were calculated.

The ideal or “target” LOS was set using the 2022 mid‐year Global Tracheostomy Report for pediatric member hospitals; it was 121 days [16]. The institutional average LOS was tabulated. The difference between the target mean LOS and Study Aggregate LOS was calculated, labeled the Ideal Delta LOS. This data point was used to identify a potential remediable care gap.

3.4. Cost of Care Cohort—Methods for Statistical Analysis

All statistical analyses were conducted using SAS 9.4 (SAS Institute Inc., Cary, NC). All tests were conducted at the 5% level. The relationships between the demographic variables were evaluated using the Fisher's exact test.

Since the sample size was small and the normality assumption was not satisfied, group comparisons were performed using the Wilcoxon rank‐sum test.

3.5. Financial Proforma: Novel Program Design

Over an 18‐month period, an experienced and nationally recognized respiratory therapist directed a consulting firm that developed the financial and physical requirements for the implementation of this program [17]. The basic role for the PTRHMP, as delineated in collaboration with the consulting firm, was determined as follows:

• Establish DME partners “approved by hospital” for device set up and education of patient's caregivers.

• Provide 24/7 live monitoring with call‐to‐confirm alarm response by a certified respiratory therapist or paramedic of the patient's vital signs transmitted from their device to the call center.

• Escalation Policy:

  • ○
    In the event an alarm goes unanswered, a call goes out to the home.
  • ○
    In the event the call goes unanswered, then the EMS Dispatch is contacted with patient‐specific information by the center's certified respiratory therapist.
  • ○
    If the center's call is answered by a caregiver and distress is confirmed, EMS Dispatch is contacted with patient‐specific information by the center.
  • ○
    If the call is answered and all‐clear is given, the situation is noted.

This program is designed using the following materials and labor (See Figure 1):

• The Patient‐interface equipment: Masimo Rad‐97 multi‐function pulse oximeter and home ventilator (LTV, VOCSYN, and Trilogy currently meet criteria) with the transmission destination (IP address) for the monitoring center's Masimo PatientSafetyNet programmed in.

• Patient‐Monitoring Center interface: Patient‐home Wi‐Fi system to transmit the data.

• The Monitoring Center‐interface equipment: Masimo PatientSafetyNet, a software program and hardware system with a specific patient identifier code embedded.

• Active Clinical Monitoring: The PatientSafetyNet will be actively monitored 24/7 by a certified respiratory therapist and/or tracheostomy‐ and ventilator‐trained paramedic at the centralized call‐center; ventilator and pulse oximeter alarms that are unresolved after 30 s trigger a call‐to‐home for safety assessment.

• Patient‐Data to Activated EMS Dispatch: The patient demographics (name, DOB, home address, indication for tracheostomy, supplemental oxygen requirement, ventilator model and settings, local EMS dispatch information) are housed in the monitoring center, and upon need to dispatch an EMS call, the patient‐specific information is provided to the EMS Dispatch team for clinical support.

FIGURE 1.

The structure and flow of data through the Pediatric Tracheostomy Remote Home Monitoring Center (PTRHMP), as designed for the Call‐to‐Confirm Alarm Answer model in collaboration with Eventa LLC [18]. *Alarms not answered after 30 s were set as the initializing standard based on professional otolaryngologist and respiratory therapist opinions.

To achieve these goals, the consulting firm established that the total costs per month for equipment, staffing, and data analysis land at $68,400. The ideal number of enrolled patients monthly per 24/7 staffed certified respiratory therapist was calculated to be 8. The calculated PTRHMP Cost per Subject‐Day was calculated at $285.

3.6. Currency, Price Date, and Conversion

The currency is in US dollars, the price date was 2022 for the in‐patient hospitalization cohort (to capture an entire year) and 2023 for the program proposal (the year that the proposal design and calculations were completed).

3.7. Comparative Analysis

The Average Billing per Subject Day and Payment Received per Subject Day were each divided by the PTRHMP Cost per Subject Day to determine the number of monitoring days that could be paid for by eliminating each day of extended hospitalization. The Ideal Delta LOS was accepted as the potentially remediable care gap, with recovery of these days intended to open opportunities for care for more critically ill children and as a place to reduce potentially wasteful hospital care expenditures.

3.8. Potentially Avoidable Adverse Event Analysis

Adverse events were defined as preventable patient presentations to an emergency room with a tracheostomy‐related morbidity, that is, unplanned decannulation, tracheostomy tube obstruction. If the event was consistent with an ARQH No Harm event, it was not tabulated. Serious adverse events were considered those with resultant patient injury per the ARQH Levels of Harm. Charts were reviewed by the study author for all details.

3.9. Time Horizon

This proposal was defined in spring 2023 with the intention to pursue the development of the functional PTRHMP by summer 2024. Cost modeling does not change based on time in the program—there will be no reduction in costs over time due to fixed hardware and labor costs. Cost savings may be extrapolated based on:

• ○Reduced utilization of Acute Care services
• ○Reduced utilization of Emergency services
• ○Reduced level of care when weaning is appropriate

Quality of life scoring is not interpretable in the cost savings model but should be considered in the overall program evaluation of success.

3.10. Discount Rate(s)

There are no discount rates included within this proposal.

4. Results

Thirty‐three candidates met study inclusion criteria. Demographics are presented in Table 1. Males represented 55% of subjects, and 85% of subjects underwent tracheostomy tube placement under the age of 2 years. Medicaid was the predominant insurance carrier; there were five privately/commercially insured subjects in the study group (15% of the subjects). The overall racial identification of the subject families mirrored the demographics of the tracheostomy population at our institution over the last 20 years as well as the demographics of our community.

TABLE 1.

Basic demographics of all study subjects. The number of caregivers is the only statistically significant factor associated with Length of Stay (LOS).

	All subjects (N = 33)
		Mean (standard dev)	Median	p
Sex assignment at birth
Male	18 (55%)			0.722
Female	15 (45%)
Age at tracheostomy placement
Over 2 years old	5 (15%)			0.6269
Under 2 years old	28 (85%)
Racial/ethnic identification
White, Non‐Hispanic	14 (42%)			0.2777
Black, Non‐Hispanic	14 (42%)
Hispanic	5 (15%)
Insurer
Commercial/private	5 (15%)			0.2911
Medicaid	28 (85%)
Average Child Opportunity Index (COI)	2.2	2.12 (±1.22)	2 (“low”)	0.0627
Number of caregivers	1.8			< 0.0001.
Number of siblings under the 5 years of age	1.06	1.06 (±1.06)	1	0.1068

Note: Bold indicates statistically significant data point.

The average COI for the subjects' home address was 2.2, which translated to “community resources in the low to moderate range.” The average number of caregivers identified and fully trained prior to discharge was 1.82. All subjects had insurance approval for Home Health Nursing, up to 40 h per week for all subjects. No subject in this study (0 of 33) had a Home Health Nurse available at the time of discharge to home. The single most influential factor influencing the LOS was age at tracheostomy placement. Subjects with placement over the age of 2 years had statistically significantly shorter hospitalization after tracheostomy placement (p = 0.0381) (See Table 2).

TABLE 2.

Controlling for length of stay (LOS), each demographic was assessed and is reported below as a comparison risk.

Factor	Estimate	Standard error	p
COI	−4.67	16.88	0.7843
Number of siblings	−24.15	19.122	0.2193
Gender
Female vs. male	27.91	41.242	0.5053
Insurer
Commercial/private vs. Medicaid	−2.29	59.42	0.9696
Race
Black vs. White	54.87	42.36	0.2081
Hispanic vs. White	16.15	60.03	0.7903
Caregiver structure
1 vs. 2/3	54.46	75.258	0.4766
Age
Over age 2 vs. under age 2 years	−119.01	54.08	0.0381

Note: Italics indicates statistically significant values. For example, the Black subjects had a mean LOS that was nearly 55 days longer than the White subjects. Age of tracheostomy placement, over or under 2 years of age, was the only statistically significant influential factor: Subjects over 2 years of age at tracheostomy had a mean LOS 119 days shorter than the subjects under 2 years of age (p < 0.0381). Note that the standard errors are very large, due to the low power of the study (0.33) and the high variance.

The Cost of Care data is compiled in Table 3. This demonstrates billing, payments received, and daily assessment for all Subjects. The “target” LOS was set at 121 days, per the GTC mean LOS. The average LOS was longer than the “target” by 31.6 days, or 1 month.

TABLE 3.

Financial data for all subjects over the 2‐year study period.

	All subjects (N = 33)
	Mean	Standard deviation	Median
Total hospital days	5004
Length of stay (LOS)	151.6	109.9	130
Difference between mean length of stay and target length of stay (LOS = 120 days or less)	31.6	108.9	10
Total CHARGES	$87,597,461.06
CHARGES per day	$17,406.53	$4067.41	$16,471.53
Total PAYMENTS	$14,335,105.67
PAYMENTS per day	$3328.95	$2385.18	$2531.90
Total reduction in billing by meeting target	$18,442,033.70
Total reduction in payment received by meeting target	$3,017,993.06

Note: For 33 subjects, 5004 hospital days were accounted for, examining the charges billed (CHARGES) and the payments received (PAYMENTS). The Mean LOS was 151.6 days, which was 31.6 days longer than the target (ideal) LOS, defined using the Global Tracheostomy Collaborative mean LOS for member pediatric institutions as of mid‐year 2022 (120 days).

The reduction of in‐hospital costs represents approximately $17,000 healthcare dollars billed per day if achieving the target (GTC mean) discharge goal. Further dissected, payments comprised an average of $3000 per patient‐day of actual healthcare dollars spent.

4.1. Program Design Cost Analysis

According to the personal communication from the consulting firm, the cost of 1 month of extended remote home monitoring for pediatric tracheostomy patients 24 h daily, 7 days per week is projected at $68,400 per 8‐patient group. This cost decreases with the addition of patients to the system. The projected cost per patient‐day with a minimum 8‐patient grouping is $285 for outpatient continuous at‐home event monitoring with a telephone safety call, with EMS activation when indicated, and with direct communication of patient medical data to the EMS team at activation. Table 4 details the breakdown of the $285/day PTRHMP cost into the following components: Equipment, Staffing (e.g., 24/7 monitoring FTE assumptions), Software/licensing, Overhead or infrastructure. Table 5 details the basic sensitivity analysis relating cost per patient‐day variation with enrollment (e.g., 6, 8, 10 patients per RT).

TABLE 4.

The breakdown of the $285/day PTRHMP cost into the following components: Equipment, Staffing (e.g., 24/7 monitoring FTE assumptions), Software/licensing, Overhead or infrastructure.

# of pts	Staffing	Overhead/inf	Software license	Equipment and supplies
1	99%	0.18%	0.1%	0.5%
2	97%	0.36%	0.4%	2.0%
3	94%	0.52%	0.9%	4.3%
4	90%	0.67%	1.5%	7.4%
5	86%	0.79%	2.2%	11.0%
6	81%	0.90%	3.0%	14.9%
7	76%	0.98%	3.8%	19.0%
8	71%	1.05%	4.6%	23.2%

TABLE 5.

The basic sensitivity analysis relating cost per patient‐day variation with enrollment (e.g., 6, 8, 10 patients per RT).

# of pts	Daily labor cost	Overhead/infrastructure	Daily supp cost	Daily access cost	Avg daily equip cost	Per diem cost
1	$1632.00	$3.00	$3.45	$1.67	$4.86	$1644.98
2	$816.00	$3.00	$6.90	$3.33	$9.73	$838.96
3	$544.00	$3.00	$10.35	$5.00	$14.59	$576.94
4	$408.00	$3.00	$13.80	$6.67	$19.45	$450.92
5	$326.40	$3.00	$17.25	$8.33	$24.32	$379.30
6	$272.00	$3.00	$20.70	$10.00	$29.18	$334.88
7	$233.14	$3.00	$24.15	$11.67	$34.04	$306.00
8	$204.00	$3.00	$27.60	$13.33	$38.90	$286.84

For all study subjects, the savings in healthcare dollars generated by each one‐day decrease in hospitalization are offset by enrollment in the program for 11.7 days.

4.2. Potentially Avoidable Adverse Events Analysis

Among the study subjects with unplanned readmissions to the emergency room, there were four potentially preventable adverse events in the first 6 months after discharge to home. Three were serious adverse events. One preventable adverse event had no sequela; three preventable adverse events with adverse sequelae were identified: two airway obstructions due to tracheostomy tube mucous plugging and one ventilator power failure. All three resulted in anoxic brain injury that was so severe that the families opted to allow a natural death.

5. Discussion

The incidence of pediatric tracheostomy has increased. We observed increased inpatient census consequently. Since 2018, the average daily census for pediatric tracheostomy patients at our institution has been tracked. The average daily census for each month, reflecting the gradual rise in case numbers as reported herein, is visible in Figure 2. This represents increased utilization of in‐patient hospitalization and potentially critical care resources over this time frame. Optimizing the LOS after pediatric tracheostomy improves access to inpatient care for other patients while enhancing the opportunity for the pediatric tracheostomy patient to experience an improved quality of life in the home. This transition, however, must be accomplished safely.

FIGURE 2.

Trach Daily Census 2018–2022 with 5‐year daily census point peaks for each month. The black arrow indicates the low point at the onset of the COVID19 crisis. The dotted black rectangle represents the annual summer plateau in census.

5.1. Purpose

Families and physicians have been dependent upon Home Health Nursing to support successful transitions in care to home. However, Home Health Nursing has faced its challenges. The nursing attrition problem has been the topic of countless studies, and it is not a new phenomenon but was clearly in full force by 2000 [6, 13]. The Home Health Nursing sector has suffered disproportionately, and in our region, we are seeing close to zero new assignments [14]. Therefore, to support our families through the transition to home, to facilitate meaningful calls for emergency medical services, and potentially to help patients progress through care to the safety of stable or tracheostomy‐independent living, we may need to consider alternatives such as the PTRHMP. There are currently a few trends‐monitoring programs, such as the UMass‐Dartmouth Oxygen Remote Home Monitoring Program for NICU graduates and the Eventa LLC monitoring center for adult skilled nursing and ventilator facilities. However, the conception of this project is the first proposed use of monitoring for children (and adults) at home, and there is no program offering live alarm‐response monitoring in the United States.

5.2. Demographic Influences Over Discharge/Barriers to Care

The ideal or “target” LOS, chosen as the mean LOS for the Global Tracheostomy Collaborative member pediatric institutions in the United States, after tracheostomy is 121 days. Ideally, the average LOS at our institution would be reduced by 31.6 days (1 month) to achieve the target.

The traditionally reported barriers to care include insurer, race/ethnicity, and community resources (COI). None of these were found to be statistically significant contributors to barriers to discharge. We reviewed additional suspected factors including multiple‐child households, two or more siblings under the age of 5, and single‐parent caregiver. Only the single‐parent caregiver status was statistically significant (p < 0.0001), specifically related to those with noted long delays in discharge due to nonmedical problems. At this institution, a mandatory two‐caregiver rule was instituted 2 years prior to this study, marking a programmatic change that was suspected to represent a barrier to discharge. Moreover, this represented a socioeconomic disadvantage that the hospital team could not overcome, with consequent challenges in caregiver availability for training, caregiver lack of housing and transportation, and caregiver employment. Moreover, no subject in this study was able to have an assigned Home Healthcare Nurse at the time of discharge to support the caregivers, regardless of finances.

When specifically controlling for LOS, the statistical analysis revealed that the placement of the tracheostomy under the age of 2 years was significant. The average stay for subjects under the age of 2 years was 119 days longer than the average LOS for subjects over 2 years (p = 0.0381). This is due, in part, to the ongoing medical needs of the premature infant. However, the primary motivation for early tracheostomy in this patient group is to expedite the transition to therapies and home care. Therefore, one might expect that this remains a modifiable factor with the correct decision‐making and clinical support. This is additionally critical to future analyses, as it defines for us two distinct clinical groups that deserve distinct analysis of outcomes and performance measures, beyond the level of surgical complexity that was the primary consideration at the time of surgery.

5.3. Financial Comparisons

At our institution, tracheostomy placement with the goals of supporting at‐home patient‐centered care has increased 500% over the last 5 years (average 1980–2017 = 5, average 2018–2023 = 25). The in‐patient average daily census supports increased on‐site support, education programs, and resource utilization. Lengthy stays beyond the essential medical needs can be expensive and prevent other children from receiving the acute care they need. The hospital billing for a tracheostomy patient was calculated around $17,000 per patient‐day; the hospital recovers approximately $3000 per patient‐day in payments received. Our institutional average LOS was 31.6 days longer than our target. Reducing the in‐patient LOS by 31.6 days represents approximately $94,800 per patient in dollars spent on that patient for in‐patient care.

The calculated monitoring center cost to pilot this novel pediatric tracheostomy safety initiative, the PTRHMP, was calculated at $285 per patient‐day, which would be $9006 per patient for the 31.6 days of recovered hospital days or less than 1/10th the recovered healthcare dollar cost for in‐patient care. For every three additional in‐hospital days, those healthcare dollars could purchase 1 month of participation in the PTRHMP.

Saving hospital dollars per tracheostomy patient frees healthcare dollars to spend on other healthcare costs, be it the monitoring program, the tracheostomy tubes, and/or other children's needs. Disposition of pediatric tracheostomy patients to at‐home care in a safe and supported environment improves the patient and family quality of life, reduces chances of hospital‐acquired infections, and promotes the cognitive and psychosocial development of the child that patients are unable to achieve in the isolation of a patient room and confinement to a crib or bed in the hospital [3, 4]. Timely disposition opens the acute or intensive care hospital room, permitting physician, nursing, and respiratory staff to attend to other patients in need of acute or critical care.

5.4. Potentially Avoidable Adverse Events Analysis

Serious adverse event with mortality occurred in three of 33 patients at home in the study period, representing a 9% morbidity/mortality rate despite comprehensive training (please refer to Appendix B) and close follow‐up care. One of the events was related to accidental decannulation, one was an unrecognized mucous plug, and one was a ventilator failure. One patient was left in the care of an untrained individual unprepared to act in the emergency. One patient was with both trained parents; the event occurred in the first 48 h after arrival at home, and the parents activated 911, but neither took the practiced steps to troubleshoot the tracheostomy effectively. In these tracheostomy‐specific events, the proper steps to assess and correct the situation were not taken by any bedside caregiver in the home environment, nor were they taken by the local Emergency Medical Services (EMS) dispatched to the home, nor the local hospital clinicians. One was corrected by the Flight Team dispatched to transfer the child, and one was corrected by this institution's respiratory therapist upon arrival in the Trauma Bay (Tracheostomy emergencies are now considered Trauma events and prioritized to the Trauma Bay with full staffing upon arrival). In all three of these events, a Home Health Nurse, PTRHMP paramedic, or PTRHMP respiratory therapist could have potentially provided advice resulting in further education for the caregiver at the bedside and a life‐saving step.

5.5. Proposal

One important alternative to the prolonged hospitalization is to harness currently available and developing technology to bring the extra support to the family. Hence, we proposed the development of a PTRHMP to provide caregiver back‐up monitoring as follows:

• –For all tracheostomy patients for a minimum of 4 weeks (1 month) from discharge, until the first follow‐up visit to determine stability at home.
• –For all ventilator‐dependent children during the minimum 4 weeks from discharge AND during ventilator transitions (aka “weans”)
• –For all tracheostomy patients for 7 days after decannulation and/or tracheocutaneous fistula closure

5.6. Funding

Any novel program must demonstrate its financial prowess beyond its moral appropriateness. There are several potential pathways to fund a PTRHMP. In the first pathway, the unused Home Healthcare Nursing dollars already dedicated within the patient's insurance program could be redirected toward monitoring until a Home Health Nurse can be identified, trained, and back‐up monitored. These are healthcare dollars that are not being spent on the patients when the patient is ready for discharge because there is no nurse available to take the job. As stated, this institution did not have a single patient discharged with a Home Health Nurse assigned in this 2‐year period. This pathway will require a “legislative policy study” wherein the existing legislative policy is reviewed to determine feasibility within existing rules.

A second pathway is to develop direct contracts between the PTRHMP and insurers, such as Eventa LLC has done since the inception of this program in collaboration with the managed Medicaid programs in Tennessee.

The third pathway is to route federal funds directed to each state that has developed its own Tax Equity and Fiscal Responsibility Act/TEFRA (P.L. 97‐248), or “Katie Beckett” program [2]. This would support the monitoring program, consistent with the initial concept (or “spirit”) of the act. This might require revisiting each state's adopted version of the 1982 Act signed into law by President Ronald Reagan. As a result of this study, the State of Louisiana has already taken two steps toward codification. In 2023, a House Resolution (LA HB 107) [19] was drafted and unanimously approved to study the financial impact of such a program. In 2024, the findings were submitted with a unanimously approved referendum to codify (LA HB 896, Act 749) [20] into law the Louisiana Home Monitoring Program Law.

5.7. Study Limitations

This study's sample size was determined by the parameters of time, examining the effects of tighter safety restrictions on transition to home care. This was specifically chosen to encompass completed hospitalizations from surgery to discharge in a defined time‐period; it was also the time‐period during which our program specified that there must be “two trained Caregivers” per family.

Pediatric tracheostomy is considered a rare disease (estimated 33,500–54,900 children in the United States have a tracheostomy [21], and “rare disease” is defined as less than 200,000 [18]). While larger studies with longer time frames could improve some deeper analyses, they introduce different biases, including inflation, shifts in healthcare secondary to effects of the COVID crisis, regional variations of culture and resources, and insurance and healthcare billing and reimbursement variations.

5.8. Real World Implications

As of 2025, there have been many well‐publicized breaches of protected information that are well‐known in the community. The data contained within this system are anticipated to be considered data subject to HIPAA, and therefore families, treating hospitals, and monitoring centers would be expected to protect the data at the minimum necessary standards expected of the healthcare system. While medical‐legal liability is always a concern, it is expected that both the monitoring center and the monitored patient's Caregivers would have a clear understanding that the system is not a substitute for high‐quality care provided in the home by appropriately trained Caregivers.

Technology literacy has lagged surprisingly in the population of Caregivers for children, and this author has observed three major health systems instituting campaigns to engage young parents of children to participate in the developing technologies of patient care portals. This suggests that despite the presumed technology literacy expected of the generation of parents, they do need to be engaged at a fundamental level until they are competent. High‐quality Caregiver training programs aim to teach to a minimum level of literacy, numeracy, and healthcare literacy. This technology literacy would be anticipated to be similar. On the other hand, parents who have engaged with their child's care have shown that their healthcare literacy is actually higher than their nontracheostomy peer population by 12 months from discharge [22], speaking to the great potential for parental success over time. In short, any newly introduced technology requires Caregiver training for competency prior to discharge from the institution.

Future studies could focus on parameters for implementation, short‐ and long‐term outcomes analysis, and safety studies. Should we have the opportunity to add this program to the existing pathways for discharge, data collected may better inform us of its healthcare benefits and its limitations or pitfalls.

6. Conclusions

The widespread adoption of a PTRHMP appears to be technologically feasible using available equipment and financially tenable at one‐10th the cost of in‐patient care. Patients under the age of two at tracheostomy placement may represent a separate subgroup for analysis. An implementation study is required to determine the level of safety compared to currently available conditions.

Disclosure

I am the sole original author, and I have produced this work myself.

Conflicts of Interest

The author declares no conflicts of interest.

Appendix A. An Historical and Sociologic Review of Pediatric Tracheostomy in the United States

The First Four Millennia

Tracheostomy and its consequences have been evolving for five millennia. The unification of Upper and Lower Egypt was represented in a hieroglyph that depicted the heart and lungs, signifying the relative importance of both in ancient Egyptian culture. In as much, hieroglyphs depict tracheostomy as early as 3100 bce (See Figure A1). The Rig Veda, or the sacred book of Hindu medicine, mentions tracheostomy around 2000 bce, and it includes a description of the healing process for the tracheal cartilages (A1). In 326 bce, Alexander the Great is memorialized for saving a soldier who aspirated a bone by opening his trachea with his sword (A2). Homer (8 bce) and Asclepiades (2 ce) are equally credited with descriptions of this clinical procedure in Ancient Greece (A1).

More than a millennium passed before Italian Brasavola (1546) “saved the first human life” in modern history with a surgical tracheostomy. Yet when Fabricius described this as a surgical procedure (1617), and he referred to it as the “Scandal of Surgery” and refused to perform the procedure. Habricot (1620) detailed a case series of four patients, publishing the first book about tracheostomy. George Martin of Scotland contributed the recommendation to use a double‐lumen tube in 1730 (A1).

Carron performed the first recorded pediatric tracheostomy in 1722, for an aspirated bean. A century later, Bretonneau (1826) performed the first pediatric tracheostomy in the setting of infectious disease—a case of diphtheria. His pupil, Trousseau, reported by 1833 to have saved 200 children who would have otherwise been lost to diphtheria if not for the procedure (A1).

From here forward, tracheostomy was further applied to the treatment of tuberculosis and poliomyelitis; for crush injuries of the chest as high‐speed trauma increased with automotive developments; for management of prolonged intubations; (A3) for treatment of chronic aspiration; and for management of chronic conditions requiring long‐term mechanical ventilation (A3).

Modernization of the Procedure

In 1909, laryngologist Chevalier Jackson presented to the American Laryngology, Rhinology and Otology Society his observation of the many risks, the benefits, and the room for improvement in tracheostomy technique, patient selection, and surgical timing to reduce iatrogenic injury (A4). Specifically quoted from his dissertation:

For with an obstructed larynx, the artificial respiration is never efficient for complete oxygenation of the blood. The trachea, under these circumstances is opened by a stab, rather than an incision, and it is small wonder if the percentage of mortality is almost as high as of stab wounds, inflicted with homicidal intent. In the hands of the most skillful and experienced, the incision is usually badly placed; in the hands of the unskilled or the excitable, serious accidents have occurred, such as the opening of the esophagus or a large vessel … There is no time for asepsis or hemostasis; the opening is made at the bottom of a pool of blood, and the first inspiration necessarily pumps clots, and possibly pus (A4).

Advances in medical care (including vaccination), adoption of commercial product safety measures (i.e., poison labeling as proposed by Dr. Jackson), and public health education about airway risks to children reduced many acute obstructive diagnoses (A5). Concurrently, advances in critical care medicine with sedation and mechanical ventilation created new opportunities for the use of tracheostomy to prevent laryngeal injury during acute but prolonged respiratory failure (A6). So while tracheostomy was invented for acute airway disorders and later popularized as a temporary, in‐hospital means by which to maintain the airway, it became adapted to other uses:

• Bridging infancy to respiratory independence for children with congenital craniofacial lesions,

• Surmounting the pulmonary injury of prematurity at the limits of survival with bronchopulmonary dysplasia and pulmonary hypertension,

• Bypassing congenital high airway obstruction syndromes (CHAOS) and acquired airway lesions.

• Overcoming short‐term (and later long‐term) ventilator dependence in the critical care unit (A7).

By the 1990s, research supported the child's need for the home physical and psychosocial environment for patient‐centered care, critical to childhood development. In 2012, the American Academy of Pediatrics began to endorse this transition in care with the adoption of the concept of “children with medical complexity” (A8).

The History of Mechanical Ventilation

Mechanical ventilation is nearing the end of its first century: the polio epidemic in the 19020s led to the invention of the Iron Lung, patented in 1927 (A9). Evolved through the “anesthesia machine” and the intensive care mechanical ventilator, the portable home ventilator was developed in the late 1970s. The United States Food and Drug Administration approved the use of the L3 ventilator outside the hospital for home ventilation in 1977 (A7). A major focus for use was on pediatric care (A7). However, this level of care remained cost prohibitive for many.

In 1981, the parents of a three‐year‐old child made a landmark decision not to keep her institutionalized. Katie Beckett had sustained infantile encephalomyelitis and required long‐term mechanical ventilation. Her family did not qualify for Medicaid support, and a legislative action resulted a year later in the Tax Equity and Fiscal Responsibility Act/TEFRA (P.L. 97‐248), signed by Ronald Reagan (1982) (A10). In many states that adopted the legislation, the resulting programs were named in her honor as the Katie Beckett Medicaid Program or Katie Beckett Waiver Program (A10). This action permits the state to ignore family income for children who are disabled and/or technology dependent. Specifically, this provides benefits to qualified children 18 years of age and under who qualify as disabled individuals under §1614 of the Social Security Act and who live at home rather than in an institution.

Transition to At‐Home Pediatric Tracheostomy

Pediatric tracheostomy in the United States remained predominantly utilized for in‐hospital care into the early 2000s, given the risks posed to children and the limitations of many outlying community resources (A11). Expansion of the use of pediatric tracheostomy in the at‐home setting (A12, A13) occurred between 2000 and 2015, the result of several events:

• –Advances in technology resulted in the development and availability of portable home technology for ventilation and oxygen monitoring.
• –Permanent and progressive incapacitation was no longer considered a terminal and unsupported diagnosis for tracheostomy and mechanical ventilation.
• –Research supported (A14, A15) and the American Academy of Pediatrics (AAP) (A16) endorsed the child's need for the home psychosocial environment for patient‐centered care as being critical to development.
• –Federal healthcare policies shifted to encourage care of chronically ill patients in less‐costly at‐home environments (A16, A17, A18, A19).

Technological advances resulted in the development of truly portable home ventilation and oxygen monitoring. Portable pulse oximetry had been invented during World War II (Millikan), using a massive metal earlobe probe for monitoring oxygen levels for safety during flights (A20). It was applied to medical uses in 1972 when Aoyagi developed standardized measurements in Japan. The American Society of Anesthesiologists declared it to be a Standard of Care in 1986, and then it was gradually adopted in healthcare from the late 1980s through the 1990s. In 1995, the first finger‐tip pulse oximeters reached the market. In 2000, Medicare accepted billing for in‐office measurements using pulse oximeters. But it was not until 2007 that the first FDA‐approved pulse oximeters appeared on the market for home use (A21).

In 2013, the well‐publicized case of Jahi McMath opened controversy over the diagnosis of brain death and the use of indefinite tracheostomy and ventilator dependence. Jahi had undergone a tonsillectomy that was complicated by post‐operative hemorrhage and secondary anoxic brain injury. While the majority of the clinicians' assessments supported the diagnosis of “brain death,” several questioned the diagnosis and her prognosis. AS such, the family denied the validity of this diagnosis and refused to allow a natural death. In a high‐profile and publicized series of events, the family used the court system to mandate placement of a tracheostomy by transferring her body from California, where she was considered legally dead, to New York, where “brain death” can legally be overlooked through a religious exemption. Over the remaining 4.5 years of her life, she was reported to be responsive to sound. This contributed to public questions regarding the validity of EEG and radionuclide cerebral perfusion scan in the diagnosis of brain death. Subsequently, public trust in the medical community began to erode in the wake of these difficult conversations (A22).

In 2017, the Neuromuscular Network via TREAT‐NMD.org published “The Standards in Care for Spinal Muscular Atrophy” (A23). On the heels of medical developments and gene therapy, this revealed a new official position that reversed the decades‐long dogma of tracheostomy and ventilator avoidance for disorders of progressive neuromuscular decline. Indefinite tracheostomy‐ and ventilator‐dependence consequently became a more popular and accessible option. Simultaneously, the AAP began developing policies to adapt to the shortage of home healthcare personnel. They developed the guidelines “Financing of Pediatric Home Health Care” and “Home Health Care of Children and Youth with Complex Health Care Needs” (A24).

These developments opened opportunities in many communities for children to transition to at‐home care with a tracheostomy and home health nursing oversight. The goals of this care are improved cognitive and social development within the biological family as opposed to the historical long‐term institutionalization with relative physical and psychosocial isolation.

The Statement of the Current Challenge: Supporting the Technology‐Dependent Child‐Family Unit

Increasing Use of Tracheostomy

Between 1980 and 2018 the incidence of tracheostomy placement at this institution was 3–5 per year. Across pediatric institutions, the need for tracheostomy alone has not diminished:

• –The incidence of prematurity has not decreased.
• –Airway instability due to prolonged intubation has not disappeared.
• –Preventable injuries due to motor vehicles, firearms, and nonaccidental trauma continue.
• –Congenital risk factors for airway compromise, such as craniofacial disorders, vascular malformations, neonatal tumors, and heart disease, persist despite even the best of prenatal care.

Between 2018 and 2022, this institution observed a 5‐fold increase in tracheostomy placement. In personal communications with other pediatric medical centers, the same trend has been observed across the nation.

Duty and Consequence

The consequences of the use of tracheostomy, and its complications, for the pediatric patient are quite profound. Central conceptually is the requirement that the patient's family embodies the full responsibility of the medically complex, technology‐dependent child in their own home 24 h a day, 7 days a week (24/7). Particularly with children who are not yet school age, this means that caregivers have no limit to their “duty hours” and are providing care at a level that many pediatric hospitals still consider to be an obligatory intensive care unit level service (Some medical facilities will permit intermediate level care; few permit standard acute level care for patients with tracheostomy with or without a ventilator).

Pediatric institutions that offer tracheostomy engage families in an institutionally developed training program with often limited standardization in the care for patients with tracheostomy in the hospital. There are limitations to recommendations for standardization of critical care steps at home. While research and years of personal experience support that families can (A12, A13) be trained to provide routine and emergency care, it must still be respected that they are not clinicians and they lack trained and experienced clinical support systems in the home (i.e., the Code Team, Rapid Response Team, Intensive Care Unit). Herein, the value of the Home Health Nurse becomes critical to safety, particularly during the transition to at‐home care.

Medicare Versus Medicaid

At‐home care is dramatically less costly than in‐hospital care, yet home health nursing hours and medical supplies remain costly for many families with tracheostomy‐dependent children (A12, A13, A14). Families often rely upon public insurance (Medicaid). In contrast to adult healthcare, the uses of these funds are legislated by the states rather than a uniform federal program. In many states, the implementation of the Medicaid programs has been delegated to one or more private healthcare management entities, further fragmenting the processes for families and threatening equitability.

Some states offer programs supporting ventilator‐assisted patients with at‐home care but not those with tracheostomy only (A14, A25). Some states offer long‐term care facilities under the supervision of the American Health Care Association that will accept patients under the age of 18 years with ventilator requirements; however, families must relinquish medical decision‐making rights. In some locations, medical daycare may be available during work hours and staffed by nurses, respiratory therapists, and Early Intervention specialists, regulated by the state's Department Human Services. Home health nurses traditionally provide clinical support in the home and with support to attend school. Over the last two decades, the nursing sector has battled attrition, disproportionately within the home health sector (A15, A26, A27, A28).

Institutional Experience

This free‐standing tertiary pediatric institution joined the Global Tracheostomy Collaborative (GTC) in 2018 with the goals of improving in‐hospital and local/regional safety with tracheostomy by implementing the five key‐drivers of the GTC process (See Appendix B). According to the mid‐year 2022 GTC data reports, our institutional post‐tracheostomy length of stay was increasing rather than decreasing. Notable changes were related to new institutional regulations: The new pulmonologists had trained at centers with community resources beyond those available in this locale. The clinicians now required “two fully trained caregivers, 24 hours daily 7 days per week with ‘eyes on the child’ all night long.”

The nursing shortage affected a lack of trained and available home health nurses. The increase in demand resulted from a 5‐fold increase in tracheostomy placement and the general lack of availability of two caregivers for full‐time bedside care. These factors created new socioeconomic barriers to at‐home care that were observed to create nonmedical delays in length of stay with the potentially preventable unnecessary utilization of costly additional resources.

Facing the Future

Technological advances including Bluetooth devices, Wi‐Fi data transmission, read‐through‐motion capability, and centralized alarm and data review have come onto the durable medical equipment market. One path forward is the use of existing technology to support families during transition. The proposed Pediatric Tracheostomy Remote Home Monitoring Program (PTRHMP) as an adjunct to support optimal home health nursing for transition to the at‐home care environment may be a financially sensible extension of support to enable the at‐home Caregiver. Alternatives and/or additional advances may lie in the development of Artificial Intelligence (AI) projects that support continuous monitoring, safe and efficient support weaning strategies, early detection of patient deterioration, and emergency response algorithms.

For the time being, we have no choice but to embrace this. We must develop better ways to prevent tracheostomy but also to support the tracheostomized child and her family. Pediatric tracheostomy is not going away.

References

• A1.J. Borman and J. T. Davidson, “History of Tracheostomy,” British Journal of Anaesthesia (1963), https://www.bjanaesthesia.org/article/S0007‐0912(17)42845‐5/fulltext.
• A2.“The Bulletin,” 2021, Norfolk and Norwich University Hospital, Norwich, UK, https://rcoa.ac.uk/sites/default/files/documents/2021‐04/Pages%20from%20Bulletin127_May%202021_Alexander%20the%20Great%20and%20Thrachetomy%20by%20Dr%20Karan%20Verma.pdf.
• A3.R. M. Kacmarek, “The Mechanical Ventilator: Past, Present, and Future,” Respiratory Care 56, no. 8 (2011): 1170–1180, https://doi.org/10.4187/respcare.01420.
• A4.M. D. Chevalier Jackson, “Tracheotomy,” 1909, ALROS Meeting, https://onlinelibrary.wiley.com/doi/10.1288/00005537‐190904000‐00003.
• A5.“Down the Hatch and Into Medical History,” NYTimes, January 10, 2011, https://www.nytimes.com/2011/01/11/health/11swallow.html.
• A6.P. Arcand and J. Granger, “Pediatric Tracheostomies: Changing Trends,” Journal of Otolaryngology 17, no. 2 (1988): 121–124.
• A7.R. N. Westhorpe and C. Ball, “The Bird Ventilator,” Anaesthesia and Intensive Care 40, no. 4 (2012): 585–585. https://doi.org/10.1177/0310057X1204000401.
• A8.C. Foster, “Shortage of Home Care Personnel Highlights Need to Strengthen Policies, Research, Systems of Care,” AAP News, December 10, 2019, https://publications.aap.org/aapnews/news/13514.
• A9.Accessed February 28, 2025, https://www.sciencemuseum.org.uk/objects‐and‐stories/medicine/iron‐lung.
• A10.“Katie Beckett Fact Sheet,” accessed July 5, 2023, https://dhcf.dc.gov/service/tax‐equity‐and‐fiscal‐responsibility‐act‐tefrakatie‐beckett.
• A11.P. A. Kuster and L. K. Badr, “Mental Health of Mothers Caring for Ventilator‐Assisted Children at Home,” Issues in Mental Health Nursing 27, no. 8 (2006): 817–835, https://doi.org/10.1080/01612840600840588.
• A12.C. King, “Long‐Term Home Mechanical Ventilation in the United States,” Respiratory Care 57, no. 6 (2012): 921–932, https://doi.org/10.4187/respcare.01741.
• A13.M. Lynch, “Home Care of the Ventilator‐Dependent Child,” Children's Health Care 19, no. 3 (1990): 169–173, https://doi.org/10.1207/s15326888chc1903_6.
• A14.S K. Chau, A. W. Yung, and S. L. Lee, “Long‐Term Management for Ventilator‐Assisted Children in Hong Kong: 2 Decades' Experience,” Respiratory Care 62, no. 1 (2017):54–64, https://doi.org/10.4187/respcare.04989.
• A15.E. R. Elias, N. A. Murphy, and Council on Children with Disabilities, “Home Care of Children and Youth With Complex Health Care Needs and Technology Dependencies,” Pediatrics 129, no. 5 (2012): 996–1005, https://doi.org/10.1542/peds.2012‐0606.
• A16.“Summary of Benchmark Changes (NHEA 2004),” CMS.org, U.S. National Health Expenditure Accounts, https://www.cms.gov/Research‐Statistics‐Data‐and‐Systems/Statistics‐Trends‐and‐Reports/NationalHealthExpendData/Downloads/benchmark2004.pdf.
• A17.“Summary of Benchmark Changes (NHEA 2009),” CMS.org, U.S. National Health Expenditure Accounts, https://www.cms.gov/research‐statistics‐data‐and‐systems/statistics‐trends‐and‐reports/nationalhealthexpenddata/downloads/benchmark2009.pdf.
• A18.“Summary of Benchmark Changes (NHEA 2014),” CMS.org, U.S. National Health Expenditure Accounts, https://www.cms.gov/research‐statistics‐data‐and‐systems/statistics‐trends‐and‐reports/nationalhealthexpenddata/downloads/benchmark2014.pdf.
• A19.“Summary of Benchmark Changes (NHEA 2019),” CMS.org, U.S. National Health Expenditure Accounts, https://www.cms.gov/files/document/summary‐benchmark‐changes‐2019.pdf.
• A20.Oxygen FAQ, “When Was the First Pulse Oximeter Invented?” Millikan Review of Scientific Instruments (1942), Severinghaus et al., Journal of Clinical Monitoring (1986), Open critical Care.org.
• A21.“History of Pulse Oximetry,” AmperorDirect USA, amperordirect.com.
• A22.A. Shewmon and N. Salamon, “The Extraordinary Case of Jahi McMath,” Perspectives in Biology and Medicine 64, no. 4 (2021): 457–478, https://doi.org/10.1353/pbm.2021.0036.
• A23.“Treat‐NMD.Org,” accessed February 26, 2023, https://treat‐nmd.org/resources‐support/care‐overview/.
• A24.Simpser, M. L. Hudak, and Section on Home Care, Committee on Childhealth Financing, “Financing of Pediatric Home Health Care,” Pediatrics 139, no. 3 (2017): e20164202, https://doi.org/10.1542/peds.2016‐4202.
• A25.L. A. Aday, D. H. Wegener, R. M. Andersen, and M. J. Aitken, “Home Care for Ventilator‐Assisted Children,” Health Affairs 8, no. 2 (1989): 137–147A.
• A26.“New Data Show Enrollment Declines in Schools of Nursing, Raising Concerns About the Nation's Nursing Workforce,” 2023, https://www.aacnnursing.org/news‐data/all‐news/new‐data‐show‐enrollment‐declines‐in‐schools‐of‐nursing‐raising‐concerns‐about‐the‐nations‐nursing‐workforce.
• A27.C. Takawira, T. C. Marufu, A. Collins, L. Vargas, L. Gillespie, A. Almaghairbi, “Factors Influencing Retention Among Hospital Nurses: Systematic Review,” British Journal of Nursing (2021), https://doi.org/10.12968/bjon.2021.30.5.302.
• A28.Baboolall and G. Berlin, “Nurses and the Great Attrition,” Podcast: McKinsey & Company, 2022, https://www.mckinsey.com/industries/healthcare/our‐insights/nurses‐and‐the‐great‐attrition#/.

FIGURE A1.

This timeline represents the recognized history of the use of tracheostomy from ancient history through the age of Chevalier Jackson in the early 1900s and up to the 2011 endorsement of at‐home care for technology‐dependent children.

Appendix B. The Institutional Experience

Global Tracheostomy Membership and Key Drivers

Baseline

This free‐standing tertiary pediatric institution joined the Global Tracheostomy Collaborative (GTC) in 2018 with the goals of improving hospital and local/regional safety with pediatric tracheostomy by implementing the five key drivers of the GTC process. At the time of enrollment, there was no institutional data on tracheostomy, including but not limited to indications for placement, in‐hospital outcomes, surgical complications, disposition process, and long‐term outcomes including death or decannulation. Each unit had its own policies and documentation. Each surgeon had their own set of expectations.

Year One

In year one, the consensus in surgical opinion was achieved through a Survey‐Monkey general assessment for areas of congruence and divergence. All surgeons performing the procedure met to review the areas of divergence to develop a pathway for consensus. Surgical technique was left open to the surgeon's discretion and the patient's condition. Routine care practices were established.

Hospital‐wide, the staff was surveyed for knowledge and comfort with skill sets, from which was formed the Needs Assessment to develop the broad staff education platform.

A multidisciplinary collaborative conference to review airway disorders and management requirements was developed. The team was able to develop common consultation pathways for Pierre Robin Sequence, a set of orders for nebulized treatments for Pseudomonas aeruginosa species and Methicillin‐resistant Staphylococcus aureus with respect to maintaining antibiotic stewardship for ciprofloxacin, and an open relationship with palliative care to support families during the transition to/through tracheostomy dependence.

The multidisciplinary clinic was established; it consisted of two otolaryngologists, full‐time participation of the respiratory therapist with the most experience with care and education for tracheostomy, and part‐time ad lib participation by a speech pathologist with experience and skill in feeding and speech. The clinic was held once monthly.

All tracheostomy placements from 1980 through the present were reviewed, including archived data. This data were transferred into the institutional GTC RedCap database. A standard procedure for data collection to enroll patients moving forward was developed. The first institutional data analysis was completed.

Uniform bedside signage for all units was implemented. Standardized notes were created for the newly implemented Epic program that would permit proper and consistent documentation of the tracheostomy‐related events while collecting information for the GTC Database.

Year Two

In year two, the broad staff online education program for nursing and respiratory staff was implemented. Routinely, nurse‐educators provided basic life support training for the designated Caregivers within the formal American Heart Association Heartsaver community life support training program.

The pediatric tracheostomy informational booklet (See Figure B1) was developed as the start of Caregiver education in making the decision to proceed to tracheostomy, the first step in family engagement. The informed consent was expanded to include more detailed information about the risks and benefits of surgery. The risks of Caregiver burnout were added. The team adopted an unwritten policy that the tracheostomy informed consent process required a caregiver to come to the hospital and be present for consent and surgery, as it was the firm belief that tracheostomy placement was not “the same as IV placement.”

FIGURE B1.

Pediatric tracheostomy informational booklet. Medical illustration courtesy of StreamStudios, Philadelphia, PA.

Patients and caregivers were equipped with red Emergency Go‐Bags (See Figure B2) and blue rolling Equipment Go‐Bags. Caregivers were educated on the optimal ways to pack and use the bags, with the understanding that the “Red‐Bag goes wherever the child goes.”

FIGURE B2.

Red Emergency Go‐Bag. Photo courtesy of author.

Weekly multidisciplinary bedside rounds commenced, and in those rounds every tracheostomy tube was changed by the team members and/or their skin care is completed (for recent tube changes). In this way, every neck and every stoma are fully inspected by the members of the team.

A standardized bedside organizer was developed to keep tracheostomy supplies organized in the same place for every patient; each new tracheostomy patient received one labeled for their personal use, and the organizer went home with the patient. Upon readmission, a hospital‐use identical organizer was placed at the bedside through admission for routine and emergency care (See Figure B3).

FIGURE B3.

Standardized bedside organizer. Photo courtesy of author.

Year Three

The Epic Note Type “Safe Trach” was created to permit the team to leave more clearly identified notes and to run filtered searches specifically for tracheostomy team notes.

The Tracheostomy Clinic expanded to include dedicated otolaryngology, respiratory, speech therapy, audiology, and gastroenterology providers. Pulmonology was available in the same workspace but was incompletely incorporated.

The online educational platform for Caregivers in English and Spanish was implemented using the very same information and imagery as the staff training platform but tailored to a broader public reading level. It was paired directly with the content of an educational binder. The goal was to keep the critical words the same but improve conceptual learning for Caregivers while enhancing their understanding of their child's medical conditions.

A hospital‐wide fundraiser event was aimed at developing a dedicated pediatric simulation center. The tracheostomy training for staff and families was selected as the core and first simulation program to be run. The collaborative multidisciplinary airway conference became AMA PRA Category 1 CME accredited.

A protocol was developed for the use of the Home Sterilizer for training parents for its implementation during the Home Trial, and for confirming nursing training as trainers for use. Sterilizers were purchased and given to each new tracheostomy family.

Year Four

In year four, standardized information was stored in the “Altered Airway” Epic FYI function, and details included were standardized using an Epic Smartphrase. This would enable the chart of a patient with a tracheostomy to be flagged upon opening with information that would potentially enhance tracheostomy safety with admissions (See Figure B4).

FIGURE B4.

Airway Alteration Chart Advisory in Epic using FYI functionality.

Data points were added to the standard operative notes and post‐operative notes to permit the hospital data analysts to voluntarily gather the information to add to the American College of Surgeons (ACS) database on peri‐operative care and complications.

The Tracheostomy Clinic again expanded to include fully incorporated otolaryngology, pulmonology, cardiology, gastroenterology, nutrition, speech pathology, audiology, and dentistry specialists. The in‐patient Tracheostomy Team additionally included palliative care support for most patients, due to the high risks of morbidity and mortality.

An internal quality assurance project examining bacterial cultures from tracheostomy patients and from patients intubated with endotracheal tubes was undertaken. There was a high incidence of coliform infections, and therefore two new safety steps were implemented:

1. The Clean Workspace was developed. A heavy effort was undertaken to educate the staff to use a clean waterproof surface for setting up tracheostomy care supplies and to encourage handwashing and gloving among healthcare providers AND the patient's home Caregiver.

2. Dedicated protocols for the intensive care unit, the emergency department, and the nurse triage line were developed with Infectious Disease and Infection Control experts on staff. These were specific to the care of the tracheostomy patient with a fever and a change in secretions with the goal of improvements in the diagnosis and management of “tracheitis”.

Year Five

In year five, the hospital formed a dedicated committee for a standard Home Trial process. This process took 8 months, resulting in a new and uniform policy across all units and an Epic workflow.

The staff knowledge base and comfort with tracheostomy‐specific skill sets were revisited using a Survey Monkey study with the same questions as the original needs assessment but incorporating the current measures in place. Two modifications resulted:

1. The existing general training platform was updated with additional chapters for the safety steps incorporated over the three‐year interval and

2. An emergency response training module was built dedicated to responders for pediatric patients with tracheostomy.

The hospital's tracheostomy care policies were reviewed and renewed. The tracheostomy decannulation policy was formalized.

Across all 5 years, family engagement events for our active patients and our graduates were held. In year one, there was a family carnival; year two, an Easter Egg hunt; year three, a Virtual World Airway Day Celebration; and then in years four and five, the program hosted Family Day at the Zoo.

Affects

With all these measures in place, this institution observed an increase in the number of patients with tracheostomy transferred into the facility and receiving primary tracheostomy placement at this facility. The incidence of tracheostomy placement per year escalated from 5 to 25 between year one and year five. Prior to year one, there was no more than 1 decannulation per year; by year five, the program averaged 15 decannulations per year.

By the end of year three, discharges of patients to at‐home care with trained caregivers were considered “efficient,” with few socioeconomic barriers and few medical barriers to discharge. The process lasted a maximum of 6 weeks but averaged closer to 4 weeks after surgical tracheostomy placement. Home health nursing availability was intermittent but not absent. Readmissions in the first month after discharge were exclusively related to feeding tube problems. No patients suffered at‐home anoxic injury. Several patients expedited their decannulation process by intentional self‐decannulation and were admitted for observation for safety. One patient sustained a water‐dump from the ventilator tubing without sequelae.

During year four, the two senior pulmonologists retired from the facility, and the newer pulmonologists that had trained at centers with more robust community resources demanded that the precise same care requirements be met for discharge. While this was not a problem with any element of the general care protocols nor the education program, the primary barrier to discharge developed related directly to the new unwritten policy of “24 hours‐7 days per week availability of at least two full‐ trained Caregivers with ‘eyes on the patient’ in the house at all times.” The nursing shortage, the lack of trained and available home health nurses, the increase in demands with a 5‐fold increase in tracheostomy placement, and the general lack of availability of 2 Caregivers for full‐time bedside care created a barrier to at‐home care that few families could overcome.

By year five, the mid‐year analysis demonstrated a dramatic lengthening of the overall average length of stay (LOS) and the LOS after tracheostomy surgery, now beyond the GTC means. Year four and year five were marked by the complete unavailability of home health nursing for pediatric patients with tracheostomy in Louisiana. Year five was marked by several at‐home morbidity events with devastating injury leading to patient loss and the impetus and means by which to begin the development of this program conceptually.