Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02690623 |
| Other study ID # |
HSC-MS-15-0978 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
January 19, 2016 |
| Last updated |
March 19, 2018 |
| Start date |
June 2016 |
| Est. completion date |
January 2019 |
Study information
| Verified date |
March 2018 |
| Source |
The University of Texas Health Science Center, Houston |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background. Hospitalists predominantly engaged in inpatient care constitute a fundamental,
poorly assessed change in medical care. The University of Texas Houston Pediatrics Department
is developing a Hospitalist Division to staff Children's Memorial Hermann Hospital.
Demonstration of its benefits and cost-effectiveness is important to secure adequate,
sustained hospital or 3rd-party reimbursement.
Design. Prospective step wedged quality improvement (QI) study with pediatric hospitalists
sequentially assuming 24/7 responsibility for each of the 4 pediatric inpatient services over
2-3 years. This design allows within- and between-group analyses and is particularly
desirable for evaluating interventions likely to be beneficial that will be given stepwise to
an increasing % of patients.
Intervention. Faculty of the new Pediatric Hospitalist Division will initially become
responsible 24/7 for 1-2 of the 4 services now staffed by the General Pediatric Division.
Currently, each pediatric service admits every other patient without regard to diagnosis,
resulting in quasi-random patient assignment.
Outcomes: Total hospital days (including 30-day readmissions); intubation; pediatric
intensive care unit (ICU) admissions; parent, nurse, and resident satisfaction; and costs
assessed using state-of-the-art methods and expressed from the health system, medical school,
and hospital perspectives.
Hypotheses. Hospitalists will improve clinical outcomes and parent, nurse, and resident
satisfaction and be cost-effective (primary outcome), assessed by net cost or savings per
hospital day prevented (health system perspective).
Analyses. Frequentist and Bayesian analyses to assess the probability of benefit and of
cost-effectiveness.
Description:
Background
Inpatient hospital services constitute the largest share (29%) of total national health care
spending. Hospitalizations for children cost $37 billion annually. The traditional model, in
which inpatient care has been provided by primary care pediatricians is being replaced by a
new model of pediatric hospitalists whose primary or exclusive professional focus is the care
of hospitalized patients. This shift has been driven by the increasing illness severity and
complexity of hospitalized children, the challenges in managing these children by
office-based pediatricians, and the increasing demand for higher quality, and more efficient
and cost-effective hospital care.
Although the pediatric hospitalist model system is being widely disseminated, its value in
improving clinical outcomes or controlling health care costs remains to be demonstrated. The
findings in studies of pediatric or adult hospitalists have been mixed, and almost all
studies have been of low quality, mostly retrospective before and after comparisons subject
to a variety of biases. With the necessity to restrain health care spending, the funding
required from Medicaid and other 3rd-party payers to develop and sustain high-quality
pediatric hospitalists services may not be forthcoming unless they are shown to improve
outcomes with acceptable or reduced costs.
The investigators propose to conduct an evaluation of the cost-effectiveness of pediatric
hospitalist care assessed as described below in a stepped wedge QI trial. The pediatric
hospitalist program will be initiated by the Department of Pediatrics with Medical School
support and is planned for stepwise implementation at Children's Memorial Hermann Hospital
(CMHH) starting in 2016.
Patient and Methods
Aims. To assess in the most rigorous feasible manner whether the pediatric hospitalist
services soon to be implemented at CMHH is cost-effective--expressed as net cost or savings
per hospital day prevented (from the health system perspective) —as well as beneficial in
improving clinical outcomes and parent, nurse, and physician satisfaction relative to that
with the general pediatrics service.
Trial Hypothesis: The hospitalist program will be cost-effective by either reducing hospital
days without increasing health system costs, reducing health system costs without increasing
hospital days, or reducing both.
Design: Stepped Wedge Quality Improvement Trial.
Rationale. It would not be desirable or feasible to use a conventional parallel group
randomized trial for at least two reasons: 1) With new hires, the number of hospitalists will
increase substantially over the study period, and a fixed allocation of patients (e.g., the
usual 1:1 ratio) to the hospitalist and general pediatrics services throughout the study
would not efficiently use these faculty; 2) Random assignment of patients would be difficult
to implement, might result in unacceptable imbalances in the number of patients assigned to
the 4 different hospitalist or general pediatric teams, and would intrude on current routines
and likely be resisted by the hospital administration.
Stepped-wedge trials involve sequential roll-out of an intervention to groups- in this care,
4 hospital services, over a number of time periods. At the end of the entire study all groups
will have received the intervention. Each serves as its own control in a before/after
comparison and also as control for other groups in comparison of groups across time.
Thus, this design allows both between group and within-group analyses. Moreover, it also
allows flexibility in deciding when to initiate a stepwise increase in patients served and in
augmenting the intervention strategy based upon problems and solutions identified over time.
This design is particularly appropriate in implementing interventions like a hospitalist
program for which there is likely clinical benefit with minimal risk, and it is not feasible
for logistical or financial reasons to either randomize or deliver the intervention
simultaneously to all participants.
To this end, the investigators will use a stepped-wedge QI trial design to serially introduce
the hospitalist program in all 4 inpatient services at CMHH currently staffed by primary care
pediatricians from the General Pediatric Division. The researchers have chosen to use this
design because it allows partial adjustment for any important temporal changes that may occur
unrelated to the intervention, and facilitates a more rigorous assessment of treatment
effects than the usual pre- and post-intervention comparisons, while also allowing the
investigators to start the project quickly with the available faculty and to focus on
optimizing hospitalist care in each service successively.
Patients. Children 18 years and younger admitted to the 4 pediatric inpatient services
(including those on observation status) at CMHH. These services include inpatient ward and
intermediate care beds. (Patients who are first admitted to the pediatric intensive care unit
[ICU] will not be considered enrolled in the study until they are transferred to the
pediatric service.)
To adjust for any important chance differences between services in baseline patient risk,
study personnel blinded to the service will categorize each child as high risk or very high
risk based on findings present on admission to a general pediatrics or hospitalist service.
This designation will be based on predefined criteria that are easily applied on admission
and related to the risk of prolonged or expensive hospitalizations (e.g. transfer from the
pediatric ICU, admission to the IMU, mechanical ventilation, with do-not-resuscitate order,
or scheduled for surgery).
Treatment Allocation. Currently, the 4 pediatric inpatient services each admit patients every
other day; the 2 admitting services each accept every other patient without regard to
diagnosis. These procedures will not be altered by the study to avoid disrupting current
hospital routines while still allowing quasi-randomized assignment to the different services
that is unaffected by the child's prior history or his/her diagnoses and condition on
admission. The order in which the hospitalist services will be implemented will be randomly
determined.
General Pediatric Services at CMHH. The attending pediatrician on each service conducts daily
morning rounds on weekdays, supervises the students and house staff and is available to the
residents by phone or in person during the day. On weeknights, an on-call pediatrician is
available to the residents by phone. On weekends two on-call pediatricians make rounds,
supervise the residents, and take call from home for the 4 services. This approach on the
General Pediatric Services will not be changed materially as hospitalists assume
responsibility for one or more of the 4 services.
Hospitalist Services at CMHH. The hospitalist services at MHH will be phased in according to
the number of hospitalists who are appointed to the new Pediatric Hospitalist Division. As
currently planned hospitalist services will involve an in-house hospitalist at all hours. The
attending hospitalist on each hospitalist service will make morning rounds on weekdays and be
present supervising the residents or providing care throughout the day. A different
hospitalist will cover at night. On weekends, one hospitalist will cover up to 2 services
each day.
Outcomes:
Primary: cost-effectiveness, expressed as net cost or savings per hospital day prevented
assessed from the health system perspective.
Secondary: Hospital days (including 30-day readmissions), severe deterioration (transfer to
the pediatric ICU, intubation, unexpected surgery, or death) days with diversion of patients
from the ED, pediatric ICU, or IMU), parent satisfaction at discharge, nurse and resident
satisfaction assessed once a year, and costs expressed from the healthcare system
perspective.
Sample Size. The sample size won't and can't be predefined. The most important problem that a
predefined sample size is used to avoid - bias in deciding when to stop enrollment -is
unlikely to be a problem when the decision to stop enrollment will be based on factors (in
this case, the recruitment of hospitalists) that are unlikely to hinge on the accrued
results. Another problem that a fixed sample size is intended to avoid is imprecision of the
effect size identified. For this study, the precision of this estimate will be limited by the
numbers of children who are admitted at the 4 services over the 2-3 year study period. This
is likely to be the largest feasible sample size that can be studied, as >8,000 admits are
expected in 3 yrs.
Statistical Analyses. All analyses will be conducted at the individual patient level using a
generalized linear mixed model (GLMM). Separate GLMMs will be used for outcome. GLMMs account
for the stepped wedge design, individual level covariates, and service level covariates, and
allow each service to have different number of patients at each time point. For all secondary
outcomes, the investigators will investigate the best fitting distributional form (i.e.,
Normal, gamma) to estimate relative risks (RRs) for the intervention effect. Each model will
include treatment group (intervention/control), time (5 planned periods), season, age,
ethnicity, insurance status, baseline patient risk, time of hospital admission (day on
weekdays: 8 am - 5 pm; weekday night; weekend) as covariates, and a random effect for child
(to account for within subject correlation due to possible repeat admissions by the same
child). Estimates of RRs and 95% credible intervals will be reported with posterior
probabilities of benefit and cost-effectiveness. Prior distributions for all covariates will
be neutral but excluding implausible large treatment effects ~N(0, SD=0.35).
Interim analyses will be performed 6 months after hospitalists become responsible for the 2nd
and 3rd services to verify that the hospitalist program does not unexpectedly worsen outcome
or increase costs before expanding the program to all 4 services. Otherwise the study will
continue as planned with final analyses performed on all patients admitted by 6 months after
the hospitalists assume responsibility for the 4th and final service. The investigators will
conclude that hospitalist program is cost effective if Bayesian analyses indicate a 90% or
higher probability that it reduces hospital days and/or reduces costs.
Cost-Effectiveness Analyses. Hospital days will be computed as the number of hospital days
after admission to any of the four services (not including any days spent in other hospitals
or the pediatric ICU before transfer to one of these services) and any subsequent readmission
occurring within 30 days of discharge. These data will be obtained by searching the claims
data for the 13 Memorial Hermann Health System hospitals. Hospitalizations outside this
system will be identified for high-risk chronically ill children as part of a separate
ongoing QI study. If as expected, parent satisfaction is increased and/or arrangements for
care after discharge is greater with hospitalist care, any rehospitalizations not identified
would be expected to be less with hospitalist care, a factor that would result in a
conservative estimate of any reduction in total hospital days with such care.
The incremental costs of hospitalist care will be related to prevented hospital days from a
healthcare system perspective following state-of-the-art guidelines. Hospital costs after
admission to one of the 4 services (excluding any prior costs incurred in the emergency room
[ER] or pediatric intensive care unit [ICU]) will be estimated using claims-based hospital
charges multiplied by department-specific cost-to-charge ratios specified in the hospital's
annual Medicare Cost Report. The costs will be inflated to 2018 U.S. dollars based on the
Consumer Price Index for medical services. Physician costs will be estimated using a relative
value unit (RVU)-based method. The resource-based RVU for each physician service provided
during hospital days will be obtained from the medical school billing system and multiplied
by the Medicare conversion factor. Costs for hospitalist care will be augmented to include
any salary differentials and/or supplements received by hospitalists for taking more night
shifts.
Differences in cost and hospital days between treatment groups will be assessed using
generalized linear models with log-link and gamma distribution. The model will include
treatment group (intervention/control), time (5 periods), season, age, ethnicity, insurance
status, baseline patient risk , time of hospital admission (day on weekdays: 8 am - 5 pm;
weekday night; weekend) as covariates, and will account for correlations within patient. The
incremental cost (savings) of hospitalist care will be computed by subtracting the mean cost
per patient in this group from the mean cost per patient in the general pediatrics group. The
incremental cost-effectiveness ratio will be computed by dividing the incremental costs
(savings) by the hospital days avoided. The investigators will also assess the robustness of
the results in sensitivity analyses by assessing the joint influence of hospitalists care on
both cost and effectiveness using the net monetary benefit approach.
Secondary Economic Analysis. Analyses from the medical school perspective will evaluate the
effect of the hospitalist intervention relative to usual care on the difference between
revenues and costs (i.e. net gain or loss) for inpatient care, excluding research-related
costs.
