Critical IllnessNCT01145443
Multicenter Intensivist Weekend Scheduling Study
An observational study of Critical Illness and Burnout, Professional, run by University of Manitoba at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Critical Illness, Burnout, Professional
- What is being tested?
- Alternative Intensivist staffing models.
- How many people
- 1,945 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2005to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted to the participating Intensive Care Units during the study period
Who may be able to join
- ICU admission contained entirely within the period of a single intensivist staffing format during the study period.
Who cannot join
- Repeat ICU admissions during the study period
- ICU admissions that overlapped more than one intensivist staffing format during the study period
Trial locations and contacts
4 sites in 1 country.
United States4 sites
MetroHealth Medical Center
Cleveland, Ohio, 44109
Ohio State University Medical Center
Columbus, Ohio, 43210
Indiana University Hospital
Indianapolis, Indiana, 46202
University of Toledo Medical Center
Toledo, Ohio, 43614
About this study
Official title: 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.
Read more
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.
- Conditions
- Critical Illness, Burnout, Professional
- Being tested
- Alternative Intensivist staffing models.
- Keywords
- Organizational models, Intensive care units, Physicians, Staffing and scheduling, Burnout, professional, Job satisfaction
- Medical subject headings
- Critical Illness, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative Intensivist staffing models.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Alternative Intensivist staffing models. | |
| 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. Receives: Other: Alternative Intensivist staffing models. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU length of stay
ICU length of stay, measured in hours
Measured: Up to 32 weeks
Secondary outcomes (6)
ICU mortality
Vital status at the end of each patients' ICU admission
Measured: Up to 32 weeks
Hospital mortality
Vital status at the end of each patient's hospitalization
Measured: Up to 1 year
Hospital length of stay
Length of stay in the hospital, in hours
Measured: Up to 1 year
Job burnout among Intensivists
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.
Measured: 2 weeks
Job stress among Intensivists
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.
Measured: 2 weeks
Imbalance between work and personal life among Intensivists
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJun 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,945 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Ohio State University, Indiana University, University of Toledo Health Science Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145443
- Sponsor's protocol ID
- IRB-05-00307
- Status last verified
- Jun 2010
- First submitted
- 14 Jun 2010
- Last updated
- 16 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ali NA, Hammersley J, Hoffmann SP, O'Brien JM Jr, Phillips GS, Rashkin M, Warren E, Garland A; Midwest Critical Care Consortium. Continuity of care in intensive care units: a cluster-randomized trial of intensivist staffing. Am J Respir Crit Care Med. 2011 Oct 1;184(7):803-8. doi: 10.1164/rccm.201103-0555OC.
PubMed 21719756
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of the Effect of Intensive Care Unit Attending Physician Work Schedules on Outcomes Relevant to Society
- ClinicalTrials.gov ID
- NCT01145443
- Acronym / sponsor ID
- IRB-05-00307
- Conditions
- Critical Illness, Burnout, Professional
- Keywords
- Organizational models, Intensive care units, Physicians, Staffing and scheduling, Burnout, professional, Job satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,945 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Ohio State University, Indiana University, University of Toledo Health Science Campus
- Study start
- Jun 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous intensivist staffing model | – | Other: Alternative Intensivist staffing models.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). |
| Discontinuous intensivist staffing model | – | Other: Alternative Intensivist staffing models.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. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to the participating Intensive Care Units during the study period
Key inclusion criteria (1 listed)
- ICU admission contained entirely within the period of a single intensivist staffing format during the study period.
Key exclusion criteria (2 listed)
- Repeat ICU admissions during the study period
- ICU admissions that overlapped more than one intensivist staffing format during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternative Intensivist staffing models.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. | Other | Continuous intensivist staffing model, Discontinuous intensivist staffing model |
Primary outcome
ICU length of stay
Time frame: Up to 32 weeks
ICU length of stay, measured in hours
6 secondary outcomes
ICU mortality
Time frame: Up to 32 weeks
Hospital mortality
Time frame: Up to 1 year
Hospital length of stay
Time frame: Up to 1 year
Job burnout among Intensivists
Time frame: 2 weeks
Job stress among Intensivists
Time frame: 2 weeks
Imbalance between work and personal life among Intensivists
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2010.
- Derived from this study: PubMed 21719756Ali NA, Hammersley J, Hoffmann SP, O'Brien JM Jr, Phillips GS, Rashkin M, Warren E, Garland A; Midwest Critical Care Consortium. Continuity of care in intensive care units: a cluster-randomized trial of intensivist staffing. Am J Respir Crit Care Med. 2011 Oct 1;184(7):803-8. doi: 10.1164/rccm.201103-0555OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Burnout, Professional, run by University of Manitoba at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU length of stay (time frame: Up to 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01145443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2010.