- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01323816
Differences in Care Provided in Intensive Care Units (ICUs) With Physician Versus Nurse Practitioner First Responders
June 25, 2014 updated by: Naeem Ali, MD
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
3659
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43015
- The Ohio State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Any patients being seen at designated ICU during the time period being investigated.
Description
Inclusion Criteria:
- Patients admitted to designated ICU between September 1, 2007 and September 30, 2010.
Exclusion Criteria:
- Not admitted to designated ICU.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Traditional
ICU staffed by a resident, pulmonary fellow and attending
|
There is no research directed care.
Patients are treated as medically indicated.
|
|
Non-Traditional
ICU staffed by Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending
|
There is no research directed care.
Patients are treated as medically indicated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2007 - 2010
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intensive Care Unit (ICU) mortality
Time Frame: 2007 - 2010
|
2007 - 2010
|
|
|
Hospital mortality
Time Frame: 2007 - 2010
|
2007 - 2010
|
|
|
Time to death
Time Frame: 2007 - 2010
|
2007 - 2010
|
|
|
Ventilator Days
Time Frame: 2007 - 2010
|
2007 - 2010
|
|
|
Ventilator-free days
Time Frame: 2007 - 2010
|
Days alive and not requiring mechanical ventilation in first 28 days after ICU admission
|
2007 - 2010
|
|
Intensive Care Unit (ICU)-free days
Time Frame: 2007 - 2010
|
Days alive and not in the ICU in first 28 days after ICU admission
|
2007 - 2010
|
|
Evidence-based care
Time Frame: 2007 - 2010
|
% of ICU days receiving evidence-based care will also be explored as mediators of other outcomes)
|
2007 - 2010
|
|
Discharge location among survivors
Time Frame: 2007 - 2010
|
2007 - 2010
|
|
|
Intensive Care Unit (ICU)Length of Stay (LOS)
Time Frame: 2007 - 2010
|
2007 - 2010
|
|
|
Hospital Length of Stay (LOS)
Time Frame: 2007 - 2010
|
2007 - 2010
|
|
|
Hospital costs
Time Frame: 2007 - 2010
|
2007 - 2010
|
|
|
Hospital charges
Time Frame: 2007 - 2010
|
2007 - 2010
|
|
|
Patient Satisfaction Survey Results
Time Frame: 2007 - 2010
|
2007 - 2010
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Naeem Ali, M.D., Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Halpern 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.
- Kleinpell 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.
- Mitchell-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.
- Pronovost 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.
- Treggiari 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
March 24, 2011
First Submitted That Met QC Criteria
March 24, 2011
First Posted (Estimate)
March 28, 2011
Study Record Updates
Last Update Posted (Estimate)
June 27, 2014
Last Update Submitted That Met QC Criteria
June 25, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009H0145
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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