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临床试验/NCT02690623
NCT02690623撤回不适用

Benefits and Cost-Effectiveness of a Pediatric Hospitalist Service : a Stepped Wedge Quality Improvement Trial

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Net cost or savings per hospital day prevented assessed from the health system perspective

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Pediatric hospitalist program (Other)

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.

干预措施: General Pediatric Inpatient Services (Other)

结局指标

主要结局

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

时间窗: up to 30 months

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.

次要结局

  • Days with diversion(up to 30 months)
  • Number of participants with severe deterioration as assessed by chart review and claims data.(up to 30 months)
  • Parent satisfaction at discharge(up to 30 months)
  • Hospital days(up to 30 months)
  • Nurse and resident satisfaction(Through study completion, an average of 2.5 years)
  • Costs of hospital services(up to 30 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elenir BC Avritscher

Assistant Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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