Critical IllnessNCT01323816
Differences in Care Provided in Intensive Care Units (ICUs) With Physician Versus Nurse Practitioner First Responders
An observational study of Critical Illness, run by Naeem Ali, MD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare outcomes of patients that have received care in medical intensive care units in a tertiary care facility with two different models; the traditional model including resident, pulmonary fellow and attending physician and a nontraditional model which has Nurse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Medically directed care
- How many people
- 3,659 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to May 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patients being seen at designated ICU during the time period being investigated.
Who may be able to join
- Patients admitted to designated ICU between September 1, 2007 and September 30, 2010.
Who cannot join
- Not admitted to designated ICU.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Process and Outcome Differences in Care Provided in Intensive Care Units (ICUs) With Physician Versus Nurse Practitioner First Responders
The purpose of this study is to evaluate and compare outcomes of patients that have received care in medical intensive care units in a tertiary care facility with two different models; the traditional model including resident, pulmonary fellow and attending physician and a nontraditional model which has Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending.
Read the detailed description
This will be a retrospective cohort study that is performed between two medical intensive care units (ICU). The goal is to compare outcomes of patients that have received care in medical intensive care units in a tertiary care facility with two different models; the traditional model including a resident, pulmonary fellow and attending and a nontraditional model which has Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending. Outcomes that will be measured include ICU length of stay, hospital length of stay after ICU discharge, ventilator days, daily spontaneous breathing trials, and daily awakening trials, as well as mortality in hospital and after discharge.
- Conditions
- Critical Illness
- Being tested
- Medically directed care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically directed careOther
There is no research directed care. Patients are treated as medically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Traditional | ICU staffed by a resident, pulmonary fellow and attending Receives: Other: Medically directed care | |
| Non-Traditional | ICU staffed by Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending Receives: Other: Medically directed care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life-years hospital costs
Life-years per $10,000 hospital costs - defined as the sum of days of survival after ICU admission for all patients admitted to each ICU/sum of all hospital costs for all patients admitted to each ICU
Measured: 2007 - 2010
Secondary outcomes (13)
Intensive Care Unit (ICU) mortality
Measured: 2007 - 2010
Hospital mortality
Measured: 2007 - 2010
Time to death
Measured: 2007 - 2010
Ventilator Days
Measured: 2007 - 2010
Ventilator-free days
Days alive and not requiring mechanical ventilation in first 28 days after ICU admission
Measured: 2007 - 2010
Intensive Care Unit (ICU)-free days
Days alive and not in the ICU in first 28 days after ICU admission
Measured: 2007 - 2010
Evidence-based care
% of ICU days receiving evidence-based care will also be explored as mediators of other outcomes)
- Sedation holidays
- Spontaneous breathing trials
- Days with continuous infusions of sedatives
- Head of bed elevation
Measured: 2007 - 2010
Discharge location among survivors
Measured: 2007 - 2010
Intensive Care Unit (ICU)Length of Stay (LOS)
Measured: 2007 - 2010
Hospital Length of Stay (LOS)
Measured: 2007 - 2010
Hospital costs
Measured: 2007 - 2010
Hospital charges
Measured: 2007 - 2010
Patient Satisfaction Survey Results
Measured: 2007 - 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naeem Ali, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naeem Ali, MD, Ohio State University
- Investigators
- Naeem Ali, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323816
- Sponsor's protocol ID
- 2009H0145
- Status last verified
- Jun 2014
- First submitted
- 24 Mar 2011
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cooper LM, Linde-Zwirble WT. Medicare intensive care unit use: analysis of incidence, cost, and payment. Crit Care Med. 2004 Nov;32(11):2247-53. doi: 10.1097/01.ccm.0000146301.47334.bd.
PubMed 15640637Halpern NA, Pastores SM, Greenstein RJ. Critical care medicine in the United States 1985-2000: an analysis of bed numbers, use, and costs. Crit Care Med. 2004 Jun;32(6):1254-9. doi: 10.1097/01.ccm.0000128577.31689.4c.
PubMed 15187502Kleinpell RM, Ely EW, Grabenkort R. Nurse practitioners and physician assistants in the intensive care unit: an evidence-based review. Crit Care Med. 2008 Oct;36(10):2888-97. doi: 10.1097/CCM.0b013e318186ba8c.
PubMed 18766097Mitchell-DiCenso A, Guyatt G, Marrin M, Goeree R, Willan A, Southwell D, Hewson S, Paes B, Rosenbaum P, Hunsberger M, Baumann A. A controlled trial of nurse practitioners in neonatal intensive care. Pediatrics. 1996 Dec;98(6 Pt 1):1143-8.
PubMed 8951267Pronovost PJ, Angus DC, Dorman T, Robinson KA, Dremsizov TT, Young TL. Physician staffing patterns and clinical outcomes in critically ill patients: a systematic review. JAMA. 2002 Nov 6;288(17):2151-62. doi: 10.1001/jama.288.17.2151.
PubMed 12413375Treggiari MM, Martin DP, Yanez ND, Caldwell E, Hudson LD, Rubenfeld GD. Effect of intensive care unit organizational model and structure on outcomes in patients with acute lung injury. Am J Respir Crit Care Med. 2007 Oct 1;176(7):685-90. doi: 10.1164/rccm.200701-165OC. Epub 2007 Jun 7.
PubMed 17556721
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process and Outcome Differences in Care Provided in Intensive Care Units (ICUs) With Physician Versus Nurse Practitioner First Responders
- ClinicalTrials.gov ID
- NCT01323816
- Acronym / sponsor ID
- 2009H0145
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,659 participants (actual)
- Lead sponsor
- Naeem Ali, MDUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Mar 2011 (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 purpose of this study is to evaluate and compare outcomes of patients that have received care in medical intensive care units in a tertiary care facility with two different models; the traditional model including resident, pulmonary fellow and attending physician and a nontraditional model which has Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending.
Detailed description
This will be a retrospective cohort study that is performed between two medical intensive care units (ICU). The goal is to compare outcomes of patients that have received care in medical intensive care units in a tertiary care facility with two different models; the traditional model including a resident, pulmonary fellow and attending and a nontraditional model which has Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending. Outcomes that will be measured include ICU length of stay, hospital length of stay after ICU discharge, ventilator days, daily spontaneous breathing trials, and daily awakening trials, as well as mortality in hospital and after discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional | – | Other: Medically directed careICU staffed by a resident, pulmonary fellow and attending |
| Non-Traditional | – | Other: Medically directed careICU staffed by Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patients being seen at designated ICU during the time period being investigated.
Key inclusion criteria (1 listed)
- Patients admitted to designated ICU between September 1, 2007 and September 30, 2010.
Key exclusion criteria (1 listed)
- Not admitted to designated ICU.
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 |
|---|---|---|
| Medically directed careThere is no research directed care. Patients are treated as medically indicated. | Other | Non-Traditional, Traditional |
Primary outcome
Life-years hospital costs
Time frame: 2007 - 2010
Life-years per $10,000 hospital costs - defined as the sum of days of survival after ICU admission for all patients admitted to each ICU/sum of all hospital costs for all patients admitted to each ICU
13 secondary outcomes
Intensive Care Unit (ICU) mortality
Time frame: 2007 - 2010
Hospital mortality
Time frame: 2007 - 2010
Time to death
Time frame: 2007 - 2010
Ventilator Days
Time frame: 2007 - 2010
Ventilator-free days
Time frame: 2007 - 2010
Intensive Care Unit (ICU)-free days
Time frame: 2007 - 2010
Evidence-based care
Time frame: 2007 - 2010
Discharge location among survivors
Time frame: 2007 - 2010
Intensive Care Unit (ICU)Length of Stay (LOS)
Time frame: 2007 - 2010
Hospital Length of Stay (LOS)
Time frame: 2007 - 2010
Hospital costs
Time frame: 2007 - 2010
Hospital charges
Time frame: 2007 - 2010
Patient Satisfaction Survey Results
Time frame: 2007 - 2010
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 27 Jun 2014.
- Background: PubMed 15640637Cooper LM, Linde-Zwirble WT. Medicare intensive care unit use: analysis of incidence, cost, and payment. Crit Care Med. 2004 Nov;32(11):2247-53. doi: 10.1097/01.ccm.0000146301.47334.bd.
- Background: PubMed 15187502Halpern NA, Pastores SM, Greenstein RJ. Critical care medicine in the United States 1985-2000: an analysis of bed numbers, use, and costs. Crit Care Med. 2004 Jun;32(6):1254-9. doi: 10.1097/01.ccm.0000128577.31689.4c.
- Background: PubMed 18766097Kleinpell RM, Ely EW, Grabenkort R. Nurse practitioners and physician assistants in the intensive care unit: an evidence-based review. Crit Care Med. 2008 Oct;36(10):2888-97. doi: 10.1097/CCM.0b013e318186ba8c.
- Background: PubMed 8951267Mitchell-DiCenso A, Guyatt G, Marrin M, Goeree R, Willan A, Southwell D, Hewson S, Paes B, Rosenbaum P, Hunsberger M, Baumann A. A controlled trial of nurse practitioners in neonatal intensive care. Pediatrics. 1996 Dec;98(6 Pt 1):1143-8.
- Background: PubMed 12413375Pronovost PJ, Angus DC, Dorman T, Robinson KA, Dremsizov TT, Young TL. Physician staffing patterns and clinical outcomes in critically ill patients: a systematic review. JAMA. 2002 Nov 6;288(17):2151-62. doi: 10.1001/jama.288.17.2151.
- Background: PubMed 17556721Treggiari MM, Martin DP, Yanez ND, Caldwell E, Hudson LD, Rubenfeld GD. Effect of intensive care unit organizational model and structure on outcomes in patients with acute lung injury. Am J Respir Crit Care Med. 2007 Oct 1;176(7):685-90. doi: 10.1164/rccm.200701-165OC. Epub 2007 Jun 7.
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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.
Naeem Ali, M.D. principal investigator
Ohio State University
1 site 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, run by Naeem Ali, MD at 1 site 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 1 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Life-years hospital costs (time frame: 2007 - 2010). 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 NCT01323816, which also lists 6 linked publications.
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 27 Jun 2014.