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临床试验/NCT01146691
NCT01146691已完成不适用

The Effect of Alternative Attending Physician Staffing Models on Outcomes for Intensive Care Unit Patients, Families, and Health Care Workers

University of Manitoba2 个研究点 分布在 1 个国家目标入组 627 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
627
试验地点
2
主要终点
Emotional Exhaustion subscale of the Maslach Burnout Inventory, among intensivists

研究概览

简要总结

Intensive Care Units (ICU) are an important, but troubled, part of modern health care systems. While it seems likely that both the technical and structural elements of ICU care are important determinants of relevant ICU outcomes, little is known about how the structure of ICU care affects outcomes. One element of potential importance is the way that ICU physicians (intensivists) organize themselves to provide ICU care, particularly at night. The dominant, historical ("standard") model of intensivist staffing involves an intensivist who is present during daytime hours, but then takes "call" at night from home. But, in recent years there has been widespread concern about whether patients experience adverse events or worse outcomes related to a lesser level of expertise and care readily available at night in hospitals. Only two studies, both from single ICUs, and both using simple before vs. after study designs, have conducted interventional studies directly comparing a "standard" intensivist staffing model with a "24-7" model of nighttime intensivist coverage via shift work, i.e. with the daytime intensivist giving way at the late afternoon to a nightshift intensivist who remained in the hospital and covered the ICU until morning. Those two studies found contradictory effects of the intervention. But despite the absence of clear data indicating a benefit to ICU patients associated with having intensivists remain in the hospital overnight, there has been a major movement around the world towards ICU staffing models utilizing shift work to ensure such coverage. The potential impact of such a change in staffing paradigm is large, with possible effects on all the other major stakeholders involved in ICU care: families, nurses, and house officers. Both benefits and detriments are possible.

On the one hand, moving to a shift work model from a model in which a single intensivist becomes overworked and sleep-deprived as a result of being responsible for care both day and night, has the potential to reduce the sleep deprivation, job distress, and burnout prevalent among intensivists with standard staffing models. But, it would also require more intensivists, a serious challenge given the worsening intensivist manpower shortage. Also, there are many detrimental effects of shift work on humans, including negative effects on motor function, cognition, sleep, job satisfaction, mood, errors, and cardiovascular health. Shift work is the most common reason that Emergency Medicine physicians give for leaving that field. The physical availability of an intensivist around-the-clock might also influence the problems mentioned of family dissatisfaction with communication in ICUs, and poor communication/ teamwork with physicians often perceived by ICU nurses. In ICUs of teaching hospitals, where relatively inexperienced house officers typically remain in the ICU overnight, the nighttime presence of an attending physician might influence residents' perceptions of domains such as teaching, and clinical autonomy.

This purpose of this study is to rigorously compare the effects of two different intensivist staffing models, specifically the current standard model, and a 24-7 staffing model enabled via shift work. This study will be conducted in two ICUs, one academic with house officers who remain in ICU overnight (the Medical ICU at Health Sciences Center), and one in a community hospital which currently lacks overnight, in-ICU physicians (the Victoria General Hospital).

This study is designed to improve upon both prior studies. To obviate the problems with using historical controls inherent in those before-vs-after study designs, our study will alternate the two staffing models (e.g. A-B-A-B). Also, the investigators will rigorously assess the effect of 24 hour intensivist presence on all major stakeholders, i.e. patients, families, intensivists, nurses, and house officers.

详细描述

Design & Procedures - General Procedures

The investigators will directly compare 2 distinct models of intensivist coverage in the 2 participating ICUs in Winnipeg:

A) The standard model: A single intensivist staffs an ICU for 7 days. He/she will is present during daytime hours, and takes call from home afterwards. This is the current staffing paradigm in both participating ICUs.

B) The 24-7 in-house coverage model: 24-7 in-hospital coverage by an intensivist is enabled by splitting each 24 hour period into two shifts. There will, as in the standard model, be a single intensivist covering the ICU during the day shifts for one week. The day shift will run 8 am to 5:30 pm on weekdays, and 8 am to 3 pm on Saturday and Sunday. The night shift intensivist will arrive and take over at 5:30 pm on weekdays, and 3 pm on weekends and remain in the hospital until 8 am. Call rooms will be provided to allow the night shift intensivist to sleep, if the workload permits.

The interventional part of the study will last 32 weeks, comprising 4 blocks of 8 weeks each. It will run from October 2008 until June 2009. During each 8 week block, each ICU will be staffed under model A or B. Thus we will alternate the models: A-B-A-B in one ICU, and B-A-B-A in the other. This alternating design obviates the problem with historical controls; any nonrandom difference between the two staffing models should be seen to come and go in this design.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

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

入选标准

  • ICU admission contained entirely within the period of a single intensivist staffing format during the study period.

排除标准

  • Repeat ICU admissions during the study period
  • ICU admissions that overlapped more than one intensivist staffing format during the study period

结局指标

主要结局

Emotional Exhaustion subscale of the Maslach Burnout Inventory, among intensivists

时间窗: 1 week

Reference: Maslach, C., W. B. Schaufeli, and M. P. Leiter. 2001. Job Burnout. Annual Review of Psychology 52:397-422.

次要结局

  • Home-work imbalance, among intensivists(1 week)
  • Role ambiguity, among intensivists(1 week)
  • Role overload, among intensivists(1 week)
  • Role conflict, among intensivists(1 week)
  • ICU mortality, among ICU patients(up to 32 weeks)
  • Hospital mortality, among ICU patients(up to 1 year)
  • ICU length of stay, among ICU patients(up to 32 weeks)
  • Hospital length of stay, among ICU patients(up to 1 year)
  • Satisfaction with care, among families of ICU patients(up to 32 weeks)
  • Satisfaction with decision-making, among families of ICU patients(up to 32 weeks)
  • Nurse-physician collaboration, as perceived by ICU nurses(8 weeks)
  • Satisfaction with communications, as perceived by ICU nurses(8 weeks)
  • Nurse-physician understanding, as perceived by ICU nurses(8 weeks)
  • Shift Communication, as perceived by ICU nurses(8 weeks)
  • Role conflict, as perceived by ICU nurses(8 weeks)
  • Autonomy, as perceived by ICU house officers(4 weeks)
  • Role conflict, as perceived by ICU house officers(4 weeks)
  • Clinical comfort, as perceived by ICU house officers(4 weeks)
  • Education/learning, as perceived by ICU house officers.(4 weeks)

研究者

申办方类型
Other

研究点 (2)

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