NCT02690623

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

2.1 years

First QC Date

January 19, 2016

Last Update Submit

March 19, 2018

Conditions

Keywords

hospitalistpediatric inpatient care

Outcome Measures

Primary Outcomes (1)

  • Net cost or savings per hospital day prevented assessed from the health system perspective

    The incremental cost-effectiveness ratio will be computed by by subtracting the mean cost per patient in the hospitalist group from the mean cost per patient in the general pediatrics group (from health system perspective) and dividing it by the hospital days avoided.

    up to 30 months

Secondary Outcomes (6)

  • Hospital days

    up to 30 months

  • Number of participants with severe deterioration as assessed by chart review and claims data.

    up to 30 months

  • Days with diversion

    up to 30 months

  • Parent satisfaction at discharge

    up to 30 months

  • Nurse and resident satisfaction

    Through study completion, an average of 2.5 years

  • +1 more secondary outcomes

Study Arms (2)

Pediatric hospitalist program

EXPERIMENTAL

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. None will work for more than 25 hours at a stretch.

Other: Pediatric hospitalist program

General Pediatric Inpatient Services

ACTIVE COMPARATOR

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 some afternoons the attending physician may be responsible for supervising care in a pediatric clinic. 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. Each service usually maintains 10-20 patients at a time and generally accepts 8-12 new admissions per admitting day. This approach on the General Pediatric Services will not be changed materially as hospitalists assume responsibility for one or more of the 4 services.

Other: General Pediatric Inpatient Services

Interventions

In-house hospitalists available at all hours

Pediatric hospitalist program

Inpatient care by general pediatrics faculty

General Pediatric Inpatient Services

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children 18 years and younger admitted to the 4 pediatric inpatient services (including those on observation status) at Children's Memorial Hermann Hospital

You may not qualify if:

  • Patients who are first admitted to the pediatric ICU will not be considered enrolled in the study until they are transferred to the pediatric service.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

Study Officials

  • Elenir BC Avritscher, MD, PhD, MBA

    The University of Texas Medical School at Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 19, 2016

First Posted

February 24, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2018

Study Completion

January 1, 2019

Last Updated

March 21, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations