An Enhanced Medical Home for High-Risk Chronically Ill Children
An Enhanced Medical Home for High-Risk Chronically Ill Children
The purpose of this study is to assess whether an enhanced medical home providing
 comprehensive care is cost-effective in preventing serious illness (death, pediatric
 intensive care admission, or hospital stay >7d) among high-risk chronically ill children.
INTRODUCTION

 Although the patient-centered medical home is widely recommended to promote cost-effective
 healthcare1-6, it has not been shown in systematic reviews to improve clinical outcomes or
 reduce medical costs.3,4 Medical homes have greatest potential value for high-risk patients,
 including chronically ill children whose care is often fragmented, costly, and ineffective.
 However, the justifiably stringent requirements for practice guidelines and the necessity to
 control health care costs require compelling evidence of cost-effectiveness before
 undertaking all that will be required to disseminate the patient-centered medical home for
 high-risk chronically ill children throughout the U.S. For this reason we propose a
 randomized trial to assess whether an enhanced medical home providing comprehensive care is
 cost-effective in preventing serious illness (death, pediatric intensive care admission, or
 hospital stay >7d) among high-risk chronically ill children in our center. Our study obtained
 expedited approval by our Institutional Review Board (IRB) as a quality improvement (QI)
 study.

 METHODS

 After verbal informed parental consent is obtained (as allowed by our institutional review
 board for a minimal-risk QI trial to increase access to care), children are randomized (using
 sealed, opaque, sequentially numbered envelopes) to usual care or comprehensive care after
 stratification by maternal education (high school graduate or not) and predicted risk of
 hospitalization (50-74%; >75%).

 Comprehensive Care involves care for acute and chronic problems from an ethnically diverse
 team of pediatricians and pediatric nurse practitioners (PNPs) who are highly trained and
 experienced in treating these complex, fragile children and available at all hours by phone
 and 40 hours/week in a special high-risk children's clinic. This clinic serves as a novel
 medical home where both primary and specialty services are provided in the same clinic at the
 same visit. The clinic is also staffed by a nutritionist and social worker and attended
 monthly by a dedicated subspecialist in pediatric gastroenterology, in neurology, and in
 allergy/immunology. A pediatric infectious disease specialist helped develop measures to
 reduce, promptly diagnose, and effectively treat infections. These subspecialists are
 available by phone for consultation at all hours. Acute problems presenting before 5 pm are
 seen that day; those occurring on weekends or nights are seen the next weekday in the
 morning. At any hour an emergency department (ED) visit or hospitalization is needed, our
 staff discusses the child with the responsible MD and schedules prompt follow-up visits.
 Multiple measures, e.g., recording and staff review of phone calls; daily checks of ED and
 hospital logs; detailed review of all care before hospitalizations; parent surveys; and
 active input of our Parent Advisory Board, are used to promote highest quality of care.

 Usual Care is provided in the offices of private pediatricians or our general pediatrics
 clinic staffed by faculty-supervised residents. Chronic problems are treated in our
 subspecialty clinics. After-hours calls from parents to our center are taken by
 faculty-supervised pediatric residents or faculty unlikely to know the child. Children
 referred to our emergency department had no automatic follow-up appointment.

 Statistical analyses and stopping rules: Intent-to-treat analyses will be performed using
 Poisson regression models with robust standard error estimators (to account for within family
 correlation and estimate relative risk) fitted to the number of children with a serious
 illness, intensive care unit admission, hospitalization > 7 days, or death. Negative binomial
 regression models will investigate group differences in the total number of such outcomes.
 Models will be adjusted for baseline risk, maternal education, and length of follow-up. A
 p<0.05 is considered statistically significant. Bayesian analyses will be performed to
 estimate the probability of reduced serious illnesses and of reduced costs (assuming a
 neutral prior probability of relative risk = 1.0; 95% credible interval = 0.5-2.0
 [encompassing the largest likely effect size for major outcomes observed in randomized
 trials]). We planned to enroll 400 patients to identify a one-third reduction in total
 patients who developed serious illness (alpha error = 0.05; power = 0.80; projected serious
 illness rate with usual care = 38%). Under predefined stopping rules, enrollment would cease
 whenever Bayesian analyses performed annually from the end of the second year identified a
 >95% probability that comprehensive care is cost-effective.

 Economic evaluation: Hospital costs (including costs for observation stays) will be estimated
 from a health system perspective by multiplying hospital charges (obtained from hospital's
 claims data and Medicaid billing records) by department-specific cost-to-charge ratios
 specified in the hospital's annual Medicare Cost Report. Outpatient costs for usual care will
 be estimated using standard methods based on relative value units. Outpatient costs for
 comprehensive care will be estimated using total clinic expenditures to include costs for
 start-up, longer patient visits, extra (unbillable) services, and low patient to staff ratios
 not addressed by relative value units. Costs will be inflated to 2014 U.S. dollars based on
 the Consumer Price Index for medical services. Cost differences between treatment groups will
 be assessed using generalized linear models with log-link and gamma distribution, adjusting
 for maternal education, hospitalization risk, length of follow-up, and within-family
 correlation.

 The investigators will consider the program to be cost-effective if it reduces the total
 children with a serious illness without increasing total clinic and hospital costs, reduced
 these costs without increasing the total children with a serious illness, or reduced both.
Inclusion Criteria:

 -  Patients 18 years old or younger with a chronic illness, high healthcare utilization
 (>3 emergency department visits, >2 hospitalizations or >1 pediatric intensive care
 unit admission in the prior year), and a >50% likelihood of hospitalization in the
 coming year (as estimated from the patient's diagnosis and clinical course by our
 clinic's medical director), who lived within a one-hour commute of our center.

 Exclusion Criteria:

 -  Patients with complex problems given primary care by a specialist at all hours (e.g.
 infants in our neonatal follow-up program and children with serious unrepaired
 congenital heart disease, a mitochondrial disorder, organ transplant, treatment with
 dialysis or central lines; or a do-not-resuscitate order).