Published online May 7, 2007
PEDIATRICS Vol. 119 No. 6 June 2007, pp. e1280-e1287 (doi:10.1542/peds.2006-2471)
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ARTICLE

Chronic Ventilator Need in the Community: A 2005 Pediatric Census of Massachusetts

Robert J. Graham, MDa, Eric W. Fleegler, MD, MPHb and Walter M. Robinson, MD, MPHc

a Division of Critical Care, Department of Anesthesiology, Perioperative, and Pain Medicine
b Division of Emergency Medicine, Department of Medicine, Children's Hospital Boston, Boston, Massachusetts
c Division of Respiratory Medicine, Department of Pediatrics, IWK Health Centre, Dalhousie Medical School, Halifax, Nova Scotia, Canada


   ABSTRACT
TOP
 ABSTRACT
METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
OBJECTIVES. The purpose of this study was to describe the population of children with chronic mechanical ventilation in Massachusetts and their patterns of medical care.

PATIENTS AND METHODS. Investigators surveyed all of the Massachusetts home ventilator clinics, pediatric pulmonary services, hospital-based pediatric services for special health care needs, insurers, home care vendors, nursing agencies, the Massachusetts Department of Public Health, selected individual providers, and rehabilitation and long-term care facilities providing services to children with chronic respiratory support needs. Support was defined as daily use of noninvasive, negative-pressure, or invasive/transtracheal ventilators. Subsequent matching of demographic data, including date of birth, zip code, and gender supported maximal census yield without duplications. Geographic information systems were used to create distribution maps and estimate distances between children with chronic mechanical ventilator needs and key resources.

RESULTS. A total of 197 children were identified as requiring chronic mechanical respiratory support in Massachusetts in 2005, which was a nearly threefold increase in this population in the 15-year interval since the last census. Congenital or perinatal-acquired neurologic or neuromuscular disorders constituted the majority of primary diagnoses (n = 107 [54%]). Chronic lung disease attributed to prematurity represented only 7% of the sample.

CONCLUSIONS. Children receiving chronic mechanical respiratory support are a growing population. The shift in underlying diagnoses from pulmonary disease to neurogenic respiratory insufficiency has implications for hospital and community-based providers from all disciplines in extending services to the home setting. Barriers encountered when performing this study, however, reflect an overall lack of coordination among the many individuals and agencies involved in their care. Coordinated and centralized care efforts require a clear and managed flow of information; census reports such as this one are only the beginning. Direct needs assessments and quality-of-life surveys from families are needed to design and implement programmatic changes and advocacy efforts.

Key Words: epidemiology • respiratory diseases • medical home • chronic disease management • disabilities

Abbreviations: CSHCN—children with special health care needs • CPAP—continuous positive airway pressure • BiPAP—biphasic positive airway pressure

Children with special health care needs (CSHCN) represent an increasing segment of the population.1,2 Advances in medical therapies and expansion of the supportive care options have contributed to the survival of a subpopulation of children with highly complex medical conditions.3 Increasing the levels of support from advanced technologies, however, is not without burden or risk. CSHCN have an increased risk of unscheduled PICU admission.4 Dosa et al4 reported that those with previous "technology-assisted care" had a relative risk of 375 for PICU admission versus children without chronic illness. Slonim et al5 found that CSHCN and technology dependence placed children at significantly higher risk of reported medical errors during hospitalization. For children whose illness requires chronic use of mechanical ventilators, the struggle to provide safe, quality care in the least restrictive environment challenges caregivers from all disciplines.6

In 1980, Burr et al7 documented 14 children with ventilator dependence in Massachusetts. Subsequent censuses in 1987 and 1990 by Palfrey and colleagues8,9 through "Project School Care" documented significant increases with ~220 children in Massachusetts with tracheostomy in place; between 70 and 77 children were estimated to be supported by chronic mechanical ventilation. At the time, these investigators projected that advances in the use of pulmonary surfactant in the neonatal period, as well as increasing sophistication in early neonatal care, would reduce the number of prospective children requiring chronic ventilator support. Such a projection assumed that prematurity would remain the primary insult leading to the need for chronic ventilation.

There are now a host of childhood conditions that can lead to the final common pathway of ventilator dependence. Population studies in other countries10–13 have shown that children with neuromuscular diseases, central hypoventilation syndromes, spinal cord injuries, and craniofacial anomalies now compose the majority of children with tracheostomy and long-term ventilation needs. In addition to the shifting etiologies of chronic respiratory failure, advances in ventilator technology (eg, portable vents and better flow-trigger mechanisms) and extension of long-term respiratory support to other populations14,15 are likely to have changed the composition of the group first observed by Burr et al7 then canvassed by Palfrey.8,9 A new census would help care systems and providers respond to current needs of this growing population.

Given the shifting landscape of clinical care for this increasingly complex population of children, we hypothesized that the number of children requiring long-term support is greater than in previous surveys, the underlying disorders are no longer principally chronic lung disease, and the majority of patients are in the home care setting. Efforts to improve the care, safety, and quality of life for children with technology dependence and their families are contingent on a better understanding of the population. The purpose of this study was to describe the population of children with chronic mechanical ventilation needs in Massachusetts and the patterns of medical care for these children.


   METHODS
TOP
 ABSTRACT
 METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
Study Population and Methods
Mechanical support needs were predefined as follows: (1) daily use of noninvasive ventilator support, including facial continuous or biphasic positive airway pressure (CPAP or BiPAP); (2) negative-pressure ventilation; or (3) chronic invasive/transtracheal ventilators. We will use the term "transtracheal" to refer to ventilation delivered by tracheostomy. The amount of time on ventilator support was set at a minimum of 6 hours per day. We acknowledge that any amount of mechanical support implies a degree of medical fragility and the need for vigilant care and monitoring and is accompanied by technical equipment burdens.

Children whose chronic respiratory support needs were limited to oxygen supplementation alone were not included in the study. We recognize that the pulmonary and cardiac conditions for these children also impact their lives and development. Greater degrees of technology, however, may serve as surrogates for disability severity,16 suggest the need for additional therapeutic services, and present logistic challenges for community providers because of physical and safety constraints. Individuals past their 22nd birthday were also excluded, because this defines the principal end point of childhood educational services and the transition from Medicaid to Medicare reimbursement programs.

Investigators contacted all of the Massachusetts home care vendors, insurers, home nursing agencies, and rehabilitation and long-term care facilities that provide services to children with chronic respiratory support needs. An additional list of physicians and other providers was generated from screening of all home ventilator clinics, pediatric pulmonary services, hospital-based pediatric services for CSHCN, and critical care providers, as well as through inquiries at the Massachusetts Consortium for Children with Special Healthcare Needs. The Massachusetts Department of Public Health was contacted as the oversight body for the state Early Intervention Program, which would enroll any child ≤3 years old. Sampling from multiple sources and subsequent matching of demographic data, including date of birth, zip code, and gender, supported maximal census yield without duplications, as well as identification of potential overlap in services (Fig 1).


Figure 1
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  		FIGURE 1 Survey method. a Category included durable medical equipment companies/home care vendors, home nursing agencies, and the Massachusetts Early Intervention Program. b Sets of twins were identified by survey sources.

 
Study Outcome and Data Analysis
The primary end points were an accurate assessment of the numbers of children throughout Massachusetts who require chronic, mechanical respiratory support. Secondary end points were characterization of the basic needs of this population and the extent of statewide resource use through evaluation of basic demographics (eg, age, gender, and zip code), care site, hospitalization history within 12 months, nature of underlying respiratory insufficiency, duration of support needs, and description of actual respiratory support systems (eg, ventilators, monitoring, and identified medical providers).

Data were entered into an SPSS 14.0 (SPSS, Inc, Chicago, IL) database for recording and analysis. Random sampling methods to equal 10% of all of the database entries were instituted to test for consistency of data entry. Primary and secondary diagnoses were recorded. The principal condition leading to respiratory insufficiency was categorized as congenital or inherited neuromuscular disorder, spinal cord injury, chronic lung disease related to prematurity, other chronic lung disease, craniofacial or upper airway abnormality, and other. Age was calculated on the basis of date of birth and date of response by the survey participant.

Descriptive statistics were computed for the entire sample and for subgroups. {chi}2 tests were used to compare the support level groups with respect to categorical variables, such as gender and care site. Analysis of variance was used to compare the ages of the patients in each support level. Geographic information systems (ArcGIS 9.1, ESRI, Inc, Redlands, CA) mapped the locations of children with chronic mechanical ventilator needs and key resources by the latitude and longitude of the centroid of their zip code. Microsoft Excel 2003 (Microsoft, Redmond, WA) was used to calculate the distances between patients and between patients and tertiary pediatric facilities using a great circle distance calculation, which accounts for the curvature of the earth.17

An a posteriori analysis of child characteristics was performed to identify those associated with need for an acute care admission in the 6-month period before census. Fisher's exact tests were used to assess whether admission to an acute care hospital was associated with mechanical support modality, primary provider type, number of different monitoring methods, diagnostic category, age (3 levels: <4, 4–13, and ≥14 years), or gender. A multivariate logistic regression was also used to look at the association between the need for acute care hospitalization and these factors simultaneously, adjusting for age and gender.

The Children's Hospital Boston Committee on Clinical Investigation reviewed and approved the study protocol. Because this was an observational study without an intervention and without the presentation of any identifying data, the committee ruled that informed consent was not necessary. Because of the small size and nature of the population of interest, there was the possibility of identification of individuals even through limited identifiers. Participants entered into a "limited data set use agreement" with the investigators in accordance with the Health Insurance Portability and Accountability Act. Each covered entity also reviewed the study internally, requesting supplemental study material as needed. Exchange of data with the Massachusetts Department of Public Health regarding Early Intervention Program enrollees was limited to assure compliance with Family Educational Rights and Privacy Act regulations. Survey responders were not asked for additional information, and the investigators did not have access to clients. Individual children or families were not contacted at any time. All of the data from this descriptive study were pooled and reported anonymously to assure protection of confidentiality.


   RESULTS
TOP
 ABSTRACT
 METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
A total of 197 children were identified as requiring chronic mechanical respiratory support in Massachusetts in 2005. Ninety-eight children (50%) received CPAP or BiPAP, whereas 97 (49%) were on invasive/transtracheal ventilators and 2 (1%) had negative-pressure devices.

Patient Characteristics
Demographic characteristics are displayed in Table 1. The median and average ages were 8.9 and 9.6 years (SD ± 6.6), respectively. Age distribution is displayed in Fig 2. There was no difference in age between children receiving transtracheal support compared with those receiving noninvasive support. Reported data on age at onset of mechanical respiratory support was limited but was skewed toward infancy and early toddlerhood (Fig 3). Gender was skewed toward boys (110 boys vs 87 girls) but was not statistically significant ({chi}12 = 2.685; P > .10).


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  		TABLE 1 Patient Characteristics

 

Figure 2
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  		FIGURE 2 Current age of children receiving chronic mechanical respiratory support (n = 196 of 197).

 

Figure 3
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  		FIGURE 3 Age at onset of chronic mechanical respiratory support (n = 89 of 197).

 
A total of 138 (70%) children were identified as being cared for at home. Only 5 (3%) of the children were living in long-term care facilities. Forty-two children (21%) had been hospitalized in an acute care facility in the previous 6 months (Table 2).


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  		TABLE 2 Patient Care Sites

 
Table 3 shows the nature and frequency of underlying diagnoses of the study population. Congenital, inherited, or perinatal-acquired neurologic or neuromuscular disorders constituted the majority of primary diagnoses (n = 107 [54%]). Chronic lung disease attributed to prematurity represented only 7% of the sample. One of the 2 patients receiving negative-pressure ventilation had chronic lung disease of prematurity, whereas the other had severe neurologic impairment after an unspecified, childhood anoxic brain injury.


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  		TABLE 3 Principal Diagnoses According to Mode of Support

 
Thirteen children had spinal muscular atrophy type 1, composing 7% of the sample. The average age at onset for support in this cohort of children was 4.67 months, with a range of <1 to 9 months. Eight of the children were receiving transtracheal support and 5 were receiving noninvasive CPAP or BiPAP. Of this cohort, 10 lived at home, whereas the 3 adolescents with spinal muscular atrophy were identified as living in a group home or hospital school.

Medical Resources and Management
Pediatric pulmonologists were identified as the primary providers for ventilator management in 61% of children (Table 4). General pediatricians were also reported as participating in ventilator management, but medical providers could not be identified in nearly one fourth of the cases. Monitoring modalities for all of the children are displayed in Table 5.


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  		TABLE 4 Principal Medical Provider for Respiratory Care

 

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  		TABLE 5 Monitoring Modality According to Support Mode

 
Figure 4 shows the geographic distribution of children throughout Massachusetts and their proximity to one another on the basis of the zip code of the primary place of residence available for 157 (78%) of 197 children. Geographic information system calculations estimate that the average distance between children with chronic mechanical respiratory support needs is 3.5 miles. Nine children have no other comparable children and an additional 6 have only 1 other comparable child living within a 10-mile radius, as demonstrated by the 10-mile buffer zones in Fig 4. The average distance to an acute-care hospital with pediatric intensive care resources is 16.7 miles, and 85.9% of identified patients live within 30 miles of such a facility.


Figure 4
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  		FIGURE 4 Geographic distribution of children with chronic mechanical respiratory support. This map is projected in the State Plane Coordinate system: Massachusetts Mainland based on the North American Datum of 1983, which minimizes distortion of the state but does project the 10-mile buffers, which are true circles, as ellipses. a Socially isolated is defined as 0 to 1 child within a 10-mile radius.

 
Patient Characteristics Associated With Need for Acute Care Services
Mechanical support mode, diagnostic category, age category, and gender were not significantly associated with need for an acute care hospitalization in the 6 months before census enrollment in bivariate analyses. Acute care admission varied by provider type, with patients identified as being managed by general pediatricians being significantly more likely to require admission than those patients of pulmonologists or other pediatric subspecialists (47%, 24%, and 8%, respectively; Fisher's P = .03). Patients with ≥2 monitoring methods were significantly more likely to have been admitted to an acute care facility (no method: 13%; 1 method: 16%; ≥2 methods: 47%; Fisher's P < .001). In multivariate logistic regression, provider type did not significantly predict the need for acute hospital admission ({chi}22 = 2.9; P = .23). Patients with ≥2 monitoring methods were significantly more likely than those with no monitoring methods to have experienced acute status (odds ratio: 6.0; 95% confidence interval: 2.2–16.2; {chi}22 = 16.9; P < .001).


   DISCUSSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
In Massachusetts,197 children required chronic mechanical respiratory support in 2005. The underlying cause for respiratory insufficiency was principally congenital, inherited, or perinatal-acquired neurologic or neuromuscular disorders for children receiving either noninvasive or transtracheal ventilation.

Our findings demonstrate a nearly threefold increase in this population in the 15-year interval since the study by Palfrey et al.8,9 The 1987 and 1990 censuses found 41 and ~70 children requiring "respirators," respectively. In addition, the clinical characteristics of the population seem to have shifted. A higher percentage of children receive ventilation for reasons related to neurologic or neuromuscular diseases as compared with children suffering from the sequelae of prematurity. This shift may be a result of advances in neonatal care, as suggested by Palfrey et al,8,9 but may also reflect the expansion of service to children with primary neurologic or neuromuscular impairments. Similar patterns have been documented in the United Kingdom,10 Japan,18 and Canada.13 CPAP and BiPAP usage has also expanded, which may be a product of increasing availability of equipment sized for younger children, as well as improved home care monitoring technology and changing practice patterns, which avoid tracheostomy.

The findings of the present study are important given the increasing emphasis on community inclusion and implementation of the medical home model. In this survey, 70% of children requiring chronic mechanical ventilation lived at home. Managing chronic ventilation for a child at home requires a tour de force of family and community resources, placing significant strain on family dynamics and finances. Although many of these families will requires support in the form of structural home adaptation, equipment delivery and maintenance, and transportation adaptations, these tangible needs may be less daunting than those requiring human capital. The greatest challenges for many of these families may relate to the allocation of human resources both inside and outside the family. In this context, it is worth noting that many census contributors could not identify a medical provider responsible for ventilator management, suggesting that access to appropriate physician services is not universal. Without physician supervision, coordination of care may become more difficult. When identified, bivariate analysis suggested that involvement of pediatric subspecialists was associated with less reporting of admission to an acute care facility, but this was not born out in the multivariate regression analysis. Qualitative interviews with Early Intervention Program staff revealed that physicians were not a consistent resource for the nonmedical community providers (R.J.G., D. M. Pemstein, MSW, and J. S. Palfrey, MD, unpublished data, 2007). Although allocation and availability of home care nursing or personal care assistants were not assessed as part of this study, they are also crucial factors when considering potential isolation, safety concerns, and the burdens placed on families and friends.

There are several limitations to our survey. First, we suspect that our total count is an underrepresentation of the population of children with chronic mechanical respiratory support needs. Although we received complete data from many sources (hospital-based providers, long-term care and rehabilitation centers, community physicians, and the Massachusetts Early Intervention Program) and one of the third-party payors, there were sources of information that were limited. In particular, we were disappointed that we could not access information from the durable medical equipment companies and the state-based insurer MassHealth to complete this census. Secondly, census data were collected over an 8-month period. This lengthy registry reflected time needed to address source-specific requirement for release of data, external data retrieval, and logistics of exchange. Attrition because of aging out or death and additions to the populations during the period of the census were likely but should not have impacted on approximate prevalence estimates. Finally, because of differences in the interpretation of limited personal identifiers between investigators and sources, the demographic data were not complete in every identified case. Some census contributors also provided incomplete data, including care site, age at onset of support, medical resources, and management, because of deficiencies in their own records. As a consequence, bivariate and multiple regression analysis of patient characteristics and need for admission to an acute care facility were also limited and do not reflect the individual patient who may have required repeated or prolonged admission. The significant relationship identified between the number of monitoring modalities and acute hospitalization likely reflects the underlying degree of illness.

This census demonstrates that children receiving chronic mechanical respiratory support are a small but growing population with implications for hospital and community-based providers from all disciplines. The shift in underlying diagnoses from pulmonary disease to neurogenic respiratory insufficiency suggests a change in the population needing expert services to remain in the home setting. Complex care requires communication and coordination; for these children and their families, communication and collaboration between multiple medical subspecialties, therapists, and home/community providers is essential. Yet, the difficulty of performing a simple census of these children suggests an overall lack of coordination among the many individuals and agencies involved in their care. Difficulty in accessing even limited clinical status records, as we encountered in performing this census, will hamper both recognition of the need for coordinated programs for this population and the implementation of such programs. It also bears recognition that these barriers to health services research were encountered in a region where there is an abundance of academic institutions and tertiary care pediatric facilities. It may be that electronic medical charts will improve the situation, but we are not optimistic. The difficulty of counting these children is more discouraging in light of the evidence that innovative and coordinated programs of care for medically vulnerable children are successful. Comprehensive programs, such as the Ventilator Assisted Children's Home Program in Pennsylvania, have established standards of care, demonstrated cost savings, and decreased mortality among enrollees.19–21

Coordinated and centralized care efforts require a clear and managed flow of information; census reports such as this one are only the beginning. Consistent identification of these children is pivotal when providing services. Direct needs assessments and quality-of-life surveys from families are needed to design and implement programmatic changes and advocacy efforts. Delineation of shortages of homecare nursing is necessary as are innovative programs and policy to foster growth in this area. Use of medical passports,22 improved discharge planning,23 coordinated follow-up,19,24 support for homecare nursing, creative use of Web-based technology, parent-to-parent support groups, and other strategies should be studied to enhance patient care, outcomes, and satisfaction and to limit the burden of care.


   ACKNOWLEDGMENTS
 
This study was supported by a grant from the Thoracic Foundation (Boston, MA).

We thank Peter Forbes, MA (Clinical Research Program, Children's Hospital Boston) for statistical assistance and Ingrid Liff, BA, Judith S. Palfrey, MD, and all of the survey participants for contributions to the implementation and completion of this study. The Massachusetts Consortium for Children With Special Health Care Needs also facilitated our contacts with numerous providers and insurers.


   FOOTNOTES
 
Accepted Nov 17, 2006.

Address correspondence to Robert J. Graham, MD, Children's Hospital Boston, M/SICU Office, Farley 517, 300 Longwood Ave, Boston, MA 02115-5724. E-mail: robert.graham{at}childrens.harvard.edu

The authors have indicated they have no financial relationships relevant to this article to disclose.


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PEDIATRICS (ISSN 1098-4275). ©2007 by the American Academy of Pediatrics




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