Critical IllnessNCT01146691
Effect of Around the Clock Intensivist Coverage on Intensive Care Unit (ICU) Outcomes
An observational study of Critical Illness and Burnout, Professional, run by University of Manitoba at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Critical Illness, Burnout, Professional, Education, Medical
- What is being tested?
- Alternative Intensivist staffing models
- How many people
- 627 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2008to Jun 2009
- 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
2 sites in 1 country.
Canada2 sites
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, R1A 1R9
Victoria General Hospital
Winnipeg, Manitoba, R3T 2E8
About this study
Official title: The Effect of Alternative Attending Physician Staffing Models on Outcomes for Intensive Care Unit Patients, Families, and Health Care Workers
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.
Read more
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.
Read the detailed description
Design \& Procedures - General Procedures
The investigators will directly compare 2 distinct models of intensivist coverage in the 2 participating ICUs in Winnipeg:
- 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.
- 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.
A variety of outcomes will be compared between the two intensivist staffing models. The primary outcome, which is the one for which the sample size analysis was performed, is the intensivists' burnout scores.
In order to avoid contamination between the staffing models, patients (and family participants) whose ICU stay is long enough to include time under both models will be excluded from analysis. Also excluded will be patients who are directly transferred from one ICU in Winnipeg to another. For patients who are admitted more than once to a participating ICU during the study, only the initial ICU admission will be included in the analysis.
The intensivists rotate on a weekly basis, and they will be provided questionnaires at the end of each week of ICU service. ICU nurses will be surveyed at the end of each 8 week block of a given staffing model. House officers in the ICU at HSC rotate on a 4 week basis, and they will be provided questionnaires at the end of their final week of their ICU rotations.
Even though the study design makes it likely (apart from the possibility of seasonal differences over the 32 weeks of the study) that participants' characteristics will be balanced between the two staffing models, this is not a randomized study and our primary analysis will use regression modeling to adjust for baseline characteristics of subjects. The investigators will use ordinary least squares or quantile regression for continuous variables, and logistic regression for binary variables. This approach permits assessment for differential effects between the two sites by including: (i) an indicator variable representing the separate sites, and (ii) interaction terms between that indicator variable and other covariates. A relevant aspect of the analysis is that outcomes for the intensivists, nurses and house officers derive from questionnaires, and that a single individual could complete the questionnaire more than once. Regression using General Estimating Equation methodology will therefore be used to account for correlation of responses within subjects.
Design \& Procedures - Specific Aims Specific Aim#1: To compare clinical outcomes for ICU patients cared for under the two intensivist staffing models.
- The Department of Medicine has long maintained a comprehensive clinical database of all patients admitted to Winnipeg ICUs. It contains information about patients' demographics, illness type and severity, comorbid conditions, and ICU and hospital course, including the outcomes for this study. The investigators will obtain a deidentified data file containing this information for patients admitted to the participating ICUs during the study period.
Specific Aim#2: To compare family satisfaction with ICU care under the two intensivist staffing models.
- On each day for each of the participating ICUs, the investigators will attempt to recruit the next-of-kin of one newly admitted patient. The investigators will use a 2 stage consent process for these participants. The investigators will use the Family Satisfaction Survey - ICU 24 for assessing family satisfaction with care. This well-validated tool has two subscales, and has been extensively used in Canadian ICUs.
Specific Aim#3: To compare the work-related personal/emotional burden for intensivists working under the two intensivist staffing models.
- The intensivists will be asked to complete multiple questionnaires. Before starting, and after concluding the intervention, all Winnipeg intensivists will be surveyed. After each one week rotation, the intensivists who worked that week in the participating ICUs will be surveyed. A single consent provided before beginning the study intervention will ask the intensivists to consent for all the questionnaire that they will receive. The initial survey establishes background information, and asks for their opinions and preferences relating to the two different intensivist staffing models. The concluding survey repeats those questions. The weekly questionnaires contain the items for the 5 scales that will be analyzed; four of those scales are validated. The fifth scale, Role Conflict, aims to assess an interaction that only occurs in the shift work staffing model, i.e. the interface between 2 intensivists doing shift-work. The investigators were unable to find any scale that addresses this sort of issue, and thus created the items ourselves.
Specific Aim#4: To compare ICU nurses' perceptions of working alongside the two intensivist staffing models.
- At the end of each 8 week block of the study, we will ask all nurses in the participating ICUs to complete a questionnaire. The questionnaire asks for background information, about the mix of shifts they worked over the prior 8 weeks, and includes items from 5 validated scales.
Specific Aim#5: To compare ICU house officers' perceptions of working under the two intensivist staffing models.
- At the end of each 4 week rotation of ICU house officers in the Medical ICU at HSC, we will ask them to complete a questionnaire. The questionnaire asks for background information, the number of previous ICU rotations they completed, and items from 4 scales. The Autonomy and Role Conflict scales are validated. The Clinical comfort and Education/learning scales have been previously used, but have not been formally validated.
- Being tested
- Alternative Intensivist staffing models
- Keywords
- Organizational models, Intensive care units, Physicians, Staffing and scheduling, Burnout, professional, Job satisfaction, Education, medical, Patient satisfaction
- Medical subject headings
- Critical Illness, Burnout, Professional, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative Intensivist staffing modelsOther
During the study period, each participating ICU alternated (ABAB or BABA) between two distinct intensivist staffing formats: (i) the standard staffing model, an intensivist is responsible for care in that ICU for the entire 7 days, being present during the daytime hours, and taking call from home at night, (ii) the 24-7 in-hospital, shiftwork model, 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard staffing model | All patients in participating ICUs during the blocks of time when a single intensivist staffs a participating ICU for a 7 day period. The intensivist will be present during daytime hours, and takes call from home afterwards. Receives: Other: Alternative Intensivist staffing models | |
| 24-7 shiftwork staffing model | All patients in participating ICUs during the blocks of time when the 24-7 in-hospital intensivist coverage model is in place. This model 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. Receives: Other: Alternative Intensivist staffing models |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Exhaustion subscale of the Maslach Burnout Inventory, among intensivists
Reference: Maslach, C., W. B. Schaufeli, and M. P. Leiter. 2001. Job Burnout. Annual Review of Psychology 52:397-422.
Measured: 1 week
Secondary outcomes (19)
Home-work imbalance, among intensivists
Reference: Kopelman, R. E., J. H. Greenhaus, and T. F. Connolly. 1983. A Model of Work, Family, and Interrole Conflict: A Construct Validation Study. Organizational Behavior and Human Performance 32:198-215.
Measured: 1 week
Role overload, among intensivists
Reference: Bacharach, S. B., P. Bamberger, and S. C. Conley. 1990. Work Processes, Role Conflict, and Role Overload: The Case of Nurses and Engineers in the Public Sector. Work and Occupations 17(2):199-228.
Measured: 1 week
Role ambiguity, among intensivists
Reference: Peterson, M. F., P. B. Smith, A. Akande, and e. al. 1995. Role Conflict, Ambiguity, and Overload: A 21-Nation Study. Academy of Management Journal 38(2):429-452.
Measured: 1 week
Role conflict, among intensivists
A 3 item scale we developed for assessing conflict occurring at the interface between 2 intensivists doing shift-work, and thus caring for the same patients.
Measured: 1 week
ICU mortality, among ICU patients
Obtained from the Winnipeg ICU database.
Measured: up to 32 weeks
Hospital mortality, among ICU patients
Obtained from the hospital charts of the two participating hospitals.
Measured: up to 1 year
ICU length of stay, among ICU patients
Obtained from the Winnipeg ICU database.
Measured: up to 32 weeks
Hospital length of stay, among ICU patients
Obtained from the hospital charts of the two participating hospitals.
Measured: up to 1 year
Satisfaction with care, among families of ICU patients
Reference: Wall, R. J., R. A. Engelberg, L. Downey, D. K. Heyland, and J. R. Curtis. 2007. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Critical Care Medicine 35(1):271-279.
Measured: up to 32 weeks
Satisfaction with decision-making, among families of ICU patients
Reference: Wall, R. J., R. A. Engelberg, L. Downey, D. K. Heyland, and J. R. Curtis. 2007. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Critical Care Medicine 35(1):271-279.
Measured: up to 32 weeks
Nurse-physician collaboration, as perceived by ICU nurses
Reference: Baggs, J. G. 1994. Development of an instrument to measure collaboration and satisfaction about care decisions. Journal of Advanced Nursing 20(1):176-182.
Measured: 8 weeks
Satisfaction with communications, as perceived by ICU nurses
Reference: Shortell, S. M., D. M. Rousseau, R. R. Gillies, K. J. Devers, and T. L. Simons. 1991. Organizational assessment in intensive care units: Construct development, reliability, and validity of the ICU nurse-physician questionnaire. Medical Care 29(8):709-27.
Measured: 8 weeks
Nurse-physician understanding, as perceived by ICU nurses
Reference: Shortell, S. M., D. M. Rousseau, R. R. Gillies, K. J. Devers, and T. L. Simons. 1991. Organizational assessment in intensive care units: Construct development, reliability, and validity of the ICU nurse-physician questionnaire. Medical Care 29(8):709-27.
Measured: 8 weeks
Shift Communication, as perceived by ICU nurses
Reference: Shortell, S. M., D. M. Rousseau, R. R. Gillies, K. J. Devers, and T. L. Simons. 1991. Organizational assessment in intensive care units: Construct development, reliability, and validity of the ICU nurse-physician questionnaire. Medical Care 29(8):709-27.
Measured: 8 weeks
Role conflict, as perceived by ICU nurses
Reference: Peterson, M. F., P. B. Smith, A. Akande, and e. al. 1995. Role Conflict, Ambiguity, and Overload: A 21-Nation Study. Academy of Management Journal 38(2):429-452.
Measured: 8 weeks
Autonomy, as perceived by ICU house officers
Reference: Fields, D. L. 2002. Taking the Measure of Work; A Guide to Validated Scales for Organizational Research and Diagnosis. Sage Publications, Thousand Oaks
Measured: 4 weeks
Role conflict, as perceived by ICU house officers
Reference: Peterson, M. F., P. B. Smith, A. Akande, and e. al. 1995. Role Conflict, Ambiguity, and Overload: A 21-Nation Study. Academy of Management Journal 38(2):429-452.
Measured: 4 weeks
Clinical comfort, as perceived by ICU house officers
Reference: Carson, S. S., C. Stocking, R. Podsadecki, J. Christenson, A. Pohlman, S. MacRae, J. Jordan, H. Humphrey, M. Siegler, and J. Hall. 1996. Effects of organizational change in the medical intensive care unit of a teaching hospital. JAMA 276(4):322-328
Measured: 4 weeks
Education/learning, as perceived by ICU house officers.
Reference: Carson, S. S., C. Stocking, R. Podsadecki, J. Christenson, A. Pohlman, S. MacRae, J. Jordan, H. Humphrey, M. Siegler, and J. Hall. 1996. Effects of organizational change in the medical intensive care unit of a teaching hospital. JAMA 276(4):322-328
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
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.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- St. Boniface Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146691
- Sponsor's protocol ID
- H2008:233
- Status last verified
- Jun 2010
- First submitted
- 16 Jun 2010
- Last updated
- 17 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Garland A, Roberts D, Graff L. Twenty-four-hour intensivist presence: a pilot study of effects on intensive care unit patients, families, doctors, and nurses. Am J Respir Crit Care Med. 2012 Apr 1;185(7):738-43. doi: 10.1164/rccm.201109-1734OC. Epub 2012 Jan 12.
PubMed 22246176
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alternative Attending Physician Staffing Models on Outcomes for Intensive Care Unit Patients, Families, and Health Care Workers
- ClinicalTrials.gov ID
- NCT01146691
- Acronym / sponsor ID
- H2008:233
- Keywords
- Organizational models, Intensive care units, Physicians, Staffing and scheduling, Burnout, professional, Job satisfaction, Education, medical, Patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- St. Boniface Hospital
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 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.
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.
Detailed description
Design \& Procedures - General Procedures
The investigators will directly compare 2 distinct models of intensivist coverage in the 2 participating ICUs in Winnipeg:
- 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.
- 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.
A variety of outcomes will be compared between the two intensivist staffing models. The primary outcome, which is the one for which the sample size analysis was performed, is the intensivists' burnout scores.
In order to avoid contamination between the staffing models, patients (and family participants) whose ICU stay is long enough to include time under both models will be excluded from analysis. Also excluded will be patients who are directly transferred from one ICU in Winnipeg to another. For patients who are admitted more than once to a participating ICU during the study, only the initial ICU admission will be included in the analysis.
The intensivists rotate on a weekly basis, and they will be provided questionnaires at the end of each week of ICU service. ICU nurses will be surveyed at the end of each 8 week block of a given staffing model. House officers in the ICU at HSC rotate on a 4 week basis, and they will be provided questionnaires at the end of their final week of their ICU rotations.
Even though the study design makes it likely (apart from the possibility of seasonal differences over the 32 weeks of the study) that participants' characteristics will be balanced between the two staffing models, this is not a randomized study and our primary analysis will use regression modeling to adjust for baseline characteristics of subjects. The investigators will use ordinary least squares or quantile regression for continuous variables, and logistic regression for binary variables. This approach permits assessment for differential effects between the two sites by including: (i) an indicator variable representing the separate sites, and (ii) interaction terms between that indicator variable and other covariates. A relevant aspect of the analysis is that outcomes for the intensivists, nurses and house officers derive from questionnaires, and that a single individual could complete the questionnaire more than once. Regression using General Estimating Equation methodology will therefore be used to account for correlation of responses within subjects.
Design \& Procedures - Specific Aims Specific Aim#1: To compare clinical outcomes for ICU patients cared for under the two intensivist staffing models.
- The Department of Medicine has long maintained a comprehensive clinical database of all patients admitted to Winnipeg ICUs. It contains information about patients' demographics, illness type and severity, comorbid conditions, and ICU and hospital course, including the outcomes for this study. The investigators will obtain a deidentified data file containing this information for patients admitted to the participating ICUs during the study period.
Specific Aim#2: To compare family satisfaction with ICU care under the two intensivist staffing models.
- On each day for each of the participating ICUs, the investigators will attempt to recruit the next-of-kin of one newly admitted patient. The investigators will use a 2 stage consent process for these participants. The investigators will use the Family Satisfaction Survey - ICU 24 for assessing family satisfaction with care. This well-validated tool has two subscales, and has been extensively used in Canadian ICUs.
Specific Aim#3: To compare the work-related personal/emotional burden for intensivists working under the two intensivist staffing models.
- The intensivists will be asked to complete multiple questionnaires. Before starting, and after concluding the intervention, all Winnipeg intensivists will be surveyed. After each one week rotation, the intensivists who worked that week in the participating ICUs will be surveyed. A single consent provided before beginning the study intervention will ask the intensivists to consent for all the questionnaire that they will receive. The initial survey establishes background information, and asks for their opinions and preferences relating to the two different intensivist staffing models. The concluding survey repeats those questions. The weekly questionnaires contain the items for the 5 scales that will be analyzed; four of those scales are validated. The fifth scale, Role Conflict, aims to assess an interaction that only occurs in the shift work staffing model, i.e. the interface between 2 intensivists doing shift-work. The investigators were unable to find any scale that addresses this sort of issue, and thus created the items ourselves.
Specific Aim#4: To compare ICU nurses' perceptions of working alongside the two intensivist staffing models.
- At the end of each 8 week block of the study, we will ask all nurses in the participating ICUs to complete a questionnaire. The questionnaire asks for background information, about the mix of shifts they worked over the prior 8 weeks, and includes items from 5 validated scales.
Specific Aim#5: To compare ICU house officers' perceptions of working under the two intensivist staffing models.
- At the end of each 4 week rotation of ICU house officers in the Medical ICU at HSC, we will ask them to complete a questionnaire. The questionnaire asks for background information, the number of previous ICU rotations they completed, and items from 4 scales. The Autonomy and Role Conflict scales are validated. The Clinical comfort and Education/learning scales have been previously used, but have not been formally validated.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard staffing model | – | Other: Alternative Intensivist staffing modelsAll patients in participating ICUs during the blocks of time when a single intensivist staffs a participating ICU for a 7 day period. The intensivist will be present during daytime hours, and takes call from home afterwards. |
| 24-7 shiftwork staffing model | – | Other: Alternative Intensivist staffing modelsAll patients in participating ICUs during the blocks of time when the 24-7 in-hospital intensivist coverage model is in place. This model 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. |
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 modelsDuring the study period, each participating ICU alternated (ABAB or BABA) between two distinct intensivist staffing formats: (i) the standard staffing model, an intensivist is responsible for care in that ICU for the entire 7 days, being present during the daytime hours, and taking call from home at night, (ii) the 24-7 in-hospital, shiftwork model, 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. | Other | 24-7 shiftwork staffing model, Standard staffing model |
Primary outcome
Emotional Exhaustion subscale of the Maslach Burnout Inventory, among intensivists
Time frame: 1 week
Reference: Maslach, C., W. B. Schaufeli, and M. P. Leiter. 2001. Job Burnout. Annual Review of Psychology 52:397-422.
19 secondary outcomes
Home-work imbalance, among intensivists
Time frame: 1 week
Role overload, among intensivists
Time frame: 1 week
Role ambiguity, among intensivists
Time frame: 1 week
Role conflict, among intensivists
Time frame: 1 week
ICU mortality, among ICU patients
Time frame: up to 32 weeks
Hospital mortality, among ICU patients
Time frame: up to 1 year
ICU length of stay, among ICU patients
Time frame: up to 32 weeks
Hospital length of stay, among ICU patients
Time frame: up to 1 year
Satisfaction with care, among families of ICU patients
Time frame: up to 32 weeks
Satisfaction with decision-making, among families of ICU patients
Time frame: up to 32 weeks
Nurse-physician collaboration, as perceived by ICU nurses
Time frame: 8 weeks
Satisfaction with communications, as perceived by ICU nurses
Time frame: 8 weeks
Nurse-physician understanding, as perceived by ICU nurses
Time frame: 8 weeks
Shift Communication, as perceived by ICU nurses
Time frame: 8 weeks
Role conflict, as perceived by ICU nurses
Time frame: 8 weeks
Autonomy, as perceived by ICU house officers
Time frame: 4 weeks
Role conflict, as perceived by ICU house officers
Time frame: 4 weeks
Clinical comfort, as perceived by ICU house officers
Time frame: 4 weeks
Education/learning, as perceived by ICU house officers.
Time frame: 4 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 17 Jun 2010.
- Derived from this study: PubMed 22246176Garland A, Roberts D, Graff L. Twenty-four-hour intensivist presence: a pilot study of effects on intensive care unit patients, families, doctors, and nurses. Am J Respir Crit Care Med. 2012 Apr 1;185(7):738-43. doi: 10.1164/rccm.201109-1734OC. Epub 2012 Jan 12.
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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.
2 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 2 sites in Canada.
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 17 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 2 sites in Canada. 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?
Emotional Exhaustion subscale of the Maslach Burnout Inventory, among intensivists (time frame: 1 week). 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 NCT01146691, 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 17 Jun 2010.