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The investigators will conduct a pilot quality improvement trial to assess the impact of offering inpatient consultation to further optimize coordination and improve care for high-risk chronically ill children receiving comprehensive care in an enhanced medical home.
Background: Comprehensive care (CC) involves care for acute and chronic conditions from a team of ethnically diverse pediatricians and nurse practitioners in the High-Risk Children's Clinic (HRCC) at The University of Texas Health Science Center at Houston (UTHealth) who are highly trained and experienced in treating medically complex and fragile children and are available 24/7 by telephone and 40 hours per week in the High-Risk Children's Clinic. This clinic serves as a novel medical home where both primary and specialty services are provided in the same place at the same visit. Acute problems presenting before 4 pm are seen the same day or if they occur over the weekend, on Monday morning. Multiple measures (daily checks of emergency department and hospital logs, parent/caregiver surveys and weekly HRCC provider team meetings) are used to promote the highest quality of care.
Comprehensive care increases access to high quality healthcare for high-risk disadvantaged children. The findings of a previous randomized trial of comprehensive care provided in the HRCC were extremely gratifying. Major benefits (54% fewer serious illnesses and 57% fewer hospital days) and savings from the health system perspective (>$10,000/child/year) were demonstrated for HRCC patients when compared to usual pediatric care (Mosquera et al., 2014). Indeed, the improvements in outcomes and reduction in costs exceed those previously reported in prior studies of medical homes for patients of any age or condition (Mosquera et al., 2014; Homer et al., 2008; Jackson et al., 2013).
Despite the demonstrated benefits, high-risk patients enrolled in our program still experience high rates of morbidity and often require hospitalization for treatment of acute exacerbations of their underlying chronic conditions. In 2015, 100 HRCC patients experienced a total of 175 admissions at Children's Memorial Hermann Hospital (CMHH) for a mean length of stay (LOS) of 7.1 days, amounting to a total of 12.3 hospital days per child-year. As a result, a pilot quality improvement (QI) trial will be conducted to assess the impact of offering inpatient consultation (IC) at CMHH to further optimize coordination and integration of inpatient and outpatient care to reduce total hospital days per child-year.
Design: Eligible HRCC patients will be randomized to either the usual inpatient care group or the comprehensive care with inpatient consultation group prior to study enrollment using a random number table. Patients will be stratified into two groups according to whether or not they are considered to have greater than median risk of repeated hospitalizations for patients in this study. Baseline clinical risk (high-risk or very high-risk) will be determined by the clinic's medical director based on the patient's diagnosis and clinical course. This approach is used to help ensure that the two treatment groups have a similar proportion of patients at very high-risk.
Data Collection and Management: Research Electronic Data Capture (REDCap) software will be utilized to collect and manage predefined study variable data. REDCap is a secure, web-based application designed to support electronic data capture for research studies providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.
Cost Assessment: Total hospital costs for CMHH admission and any ER visit or re-admission within 30 days after CMHH discharge will be assessed from a health care system perspective by multiplying total hospital charges by department-specific cost-to-charge ratios specified in the hospital's annual Medicare cost report. Hospital costs for the comprehensive care with inpatient consultation group will be augmented by the incremental HRCC personnel cost for providing inpatient consultation based on the HRCC staff salary and fringe data. The investigators will consider the program to be cost-effective if it reduces the total number of hospital days per child-year without increasing costs, reduces costs without increasing the total number of hospital days per child-year, or reduces both.
Statistical and Economic Analyses: Intent-to-treat analyses will be performed using multilevel generalized estimating equations (GEE) models to estimate rate ratios (RRs) with exchangeable correlation to account for clustering within both same patient and same family, and robust standard errors. Differences in LOS and costs between treatment groups will be assessed using GEE model with log-link and gamma distribution. In this small pilot study, some treatment effects that would be considered important by family members and clinicians (reduced hospital days) may not be statistically significant. Partly for this reason, Bayesian analyses will also be performed to estimate the probability of a benefit of a given magnitude and evaluate whether further study is justified. Neutral and skeptical priors will be used. The study will also allow us to obtain the experience and data needed to refine IC for high-risk chronically ill children. Utilizing Bayesian techniques, the power was calculated for a 70% chance the IC service would decrease hospital days and reduce health care costs. A p-value of less than .05 will be considered statistically significant. All frequentist statistical analyses will be performed using Stata version 13.1 (Stata Corp, College Station, TX). The Bayesian model will be implemented using OpenBUGS.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comprehensive Care with Inpatient consultation, Usual Inpatient Care
The University of Texas Medical School at Houston
Not yet recruiting
The University of Texas Health Science Center, Houston
Published on BioPortfolio: 2016-08-19T11:25:15-0400
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