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Multicenter Intensivist Weekend Scheduling Study

15 giugno 2010 aggiornato da: University of Manitoba

A Multicenter Study of the Effect of Intensive Care Unit Attending Physician Work Schedules on Outcomes Relevant to Society

The care of critically ill patients in Intensive Care Units (ICUs) is an important part of modern health care systems. However, ICU care suffers from similar problems as the rest of the health care system. Powerful arguments support the concept that most of problems in complex systems, such as ICUs, relates to flaws in institutional systems and processes that hinder the ability of individuals to perform their jobs well. To fix these problems, the defective systems and processes must be redesigned in ways that make it easy for people to do their job well, and hard to make mistakes. Altering the structure of ICU care for the purpose of improving ICU performance is an example of Organizational Systems Engineering, alternatively called Total Quality Management.

Another serious problem in ICU care is that after 2007 there will be a increasing shortage of physicians specializing in the care of the critically ill (Intensivists), with a 35% shortfall by 2030. One contributor to this shortage is that Intensivists retire at a younger age than do physicians in general, and often curtail their care of critically ill patients even before they retire. It is likely that the emotional and physical demands of this career choice leads Intensivists to "burn out" and leave the field prematurely. For these reasons it is important to find ways to make working as an Intensivist more sustainable so that the most experienced practitioners will continue in the field up to a normal retirement age.

The way in which groups of Intensivists organize themselves to provide care in an ICU is highly variable. One potentially important way in which Intensivist staffing differs is in the degree of continuity of care. The more days in a row that the same physician cares for a patient the greater the continuity of care. While it is generally held that a higher continuity of care results in better care and better outcomes for patients, in fact there are no studies addressing this issue. On the other side of the coin however, it seems likely that working many days in a row increases the physical and emotional burdens on the Intensivist, increasing job distress and job burnout over time.

A common pattern of Intensivist staffing, in which continuity of care is reduced, is when the Intensivist who is caring for ICU patients during the weekdays has the weekend off, during which one of his/her partners provides "cross-coverage". While it is reasonable to hypothesize that cross-coverage would lead to inefficient patient care, at the same time it may reduce the burdens on the Intensivists.

This purpose of this study is to investigate the effects of weekend cross-coverage on both ICU patients and on Intensivists. This will be a multicenter study performed in 4 member institutions of the Midwest Critical Care Consortium: The University of Toledo, MetroHealth Medical Center, Ohio State University, and Indiana University. Five adult medical ICUs from the six institutions will participate in this study, with two ICUs from the Ohio State University site.

To answer the research questions, each participating ICU will alternate between two common models of Intensivist staffing. In both models an Intensivist is responsible for ICU care for 14 days. In the Continuous model, a single Intensivist will be responsible for all 14 days. In the Discontinuous model, both weekends during the 14 days will be cross-covered by a colleague. Continuity of care is higher in the Continuous model, which has 2 physician transitions over a 4 week period, while the Discontinuous model has 8 transitions per 4 weeks. Each participating ICU will use one model for 12 weeks, then switch to the other model for 12 weeks, and finally revert back to the first model for the final 12 weeks of this 36 week study. To address problems of historical controls, seasonal differences, and to increase comparability of groups, the participating ICUs have been randomly assigned to begin the study either with the Continuous or Discontinuous model.

Comparisons will be made between the two scheduling models in: (1) patient outcomes, specifically hospital mortality rate, ICU length of stay, and hospital length of stay, and (2) Intensivist outcomes, specifically job distress, job burnout, and the balance between work and home life.

Since there is currently nothing known about whether weekend cross-coverage influences medical care, both models of care are common in ICUs. Thus the investigators expect that the findings of this study will have general relevance. While the patients admitted to the participating ICUs during this study would not be expected to benefit from this investigation, the results derived are expected to enable policy makers to make evidence-based decisions about this important aspect of ICU physician staffing and thus improve the performance and/or cost-effectiveness of ICU care, benefiting future ICU patients, and society.

Panoramica dello studio

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1945

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana University Hospital
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, Stati Uniti, 43210
        • Ohio State University Medical Center
      • Toledo, Ohio, Stati Uniti, 43614
        • University of Toledo Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

17 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

All patients admitted to the participating Intensive Care Units during the study period

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Continuous intensivist staffing model
These are the patients admitted to participating Intensive Care Units during the 3 month phases of the study when a single intensivist was the sole attending physician of record for intervals of 2 weeks (or 1/2 month).
During the study period, each participating ICU alternated between two distinct intensivist staffing formats: (i) in the Discontinuous arm of the study, there was a weekend cross-coverage format wherein an intensivist was responsible for care for a two week or half-month block, but colleagues covered the weekends within each block, or (ii) in the Continuous arm of the study, there was an uninterrupted staffing format, wherein a single intensivist was responsible for the entire two week, or half-month, period. In each ICU the study interval was divided into three phases, so that the models alternated twice in each ICU, beginning with either the weekend cross-coverage or the uninterrupted staffing formats, the four hospitals were randomly assigned between these two patterns.
Discontinuous intensivist staffing model
These are the patients admitted to participating Intensive Care Units during the 3 month phases of the study when, for intervals of 2 weeks (or 1/2 month), there was a single intensivist who was the primary attending of record during Mondays-Fridays, but cross-covering colleagues took over that role during the weekends.
During the study period, each participating ICU alternated between two distinct intensivist staffing formats: (i) in the Discontinuous arm of the study, there was a weekend cross-coverage format wherein an intensivist was responsible for care for a two week or half-month block, but colleagues covered the weekends within each block, or (ii) in the Continuous arm of the study, there was an uninterrupted staffing format, wherein a single intensivist was responsible for the entire two week, or half-month, period. In each ICU the study interval was divided into three phases, so that the models alternated twice in each ICU, beginning with either the weekend cross-coverage or the uninterrupted staffing formats, the four hospitals were randomly assigned between these two patterns.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
ICU length of stay
Lasso di tempo: Up to 32 weeks
ICU length of stay, measured in hours
Up to 32 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
ICU mortality
Lasso di tempo: Up to 32 weeks
Vital status at the end of each patients' ICU admission
Up to 32 weeks
Hospital mortality
Lasso di tempo: Up to 1 year
Vital status at the end of each patient's hospitalization
Up to 1 year
Hospital length of stay
Lasso di tempo: Up to 1 year
Length of stay in the hospital, in hours
Up to 1 year
Job burnout among Intensivists
Lasso di tempo: 2 weeks
This is a scale obtained from having the Intensivists complete surveys. It is derived from the National Study of the Changing Workforce, a large, national survey of U.S. workers performed every five years by the Families and Work Institute, and formerly performed for decades by the Unites States Department of Labor.
2 weeks
Job stress among Intensivists
Lasso di tempo: 2 weeks
This is a scale obtained from having the Intensivists complete surveys. It is derived from the National Study of the Changing Workforce, a large, national survey of U.S. workers performed every five years by the Families and Work Institute, and formerly performed for decades by the Unites States Department of Labor.
2 weeks
Imbalance between work and personal life among Intensivists
Lasso di tempo: 2 weeks
This is a scale obtained from having the Intensivists complete surveys. It is derived from the National Study of the Changing Workforce, a large, national survey of U.S. workers performed every five years by the Families and Work Institute, and formerly performed for decades by the Unites States Department of Labor.
2 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2005

Completamento primario (Effettivo)

1 settembre 2006

Completamento dello studio (Effettivo)

1 settembre 2006

Date di iscrizione allo studio

Primo inviato

14 giugno 2010

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2010

Primo Inserito (Stima)

16 giugno 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 giugno 2010

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2010

Ultimo verificato

1 giugno 2010

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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