ClinicalTrials.gov
ClinicalTrials.gov Menu

Differences in Care Provided in Intensive Care Units (ICUs) With Physician Versus Nurse Practitioner First Responders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01323816
Recruitment Status : Completed
First Posted : March 28, 2011
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Naeem Ali, MD, Ohio State University

Brief 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 Practitioners as the direct care deliverer, a pulmonary fellow, and an attending.

Condition or disease Intervention/treatment
Critical Illness Other: Medically directed care

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
Actual Enrollment : 3659 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Process and Outcome Differences in Care Provided in Intensive Care Units (ICUs) With Physician Versus Nurse Practitioner First Responders
Study Start Date : March 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Group/Cohort Intervention/treatment
Traditional
ICU staffed by a resident, pulmonary fellow and attending
Other: Medically directed care
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
Other: Medically directed care
There is no research directed care. Patients are treated as medically indicated.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Intensive Care Unit (ICU) mortality [ Time Frame: 2007 - 2010 ]
  2. Hospital mortality [ Time Frame: 2007 - 2010 ]
  3. Time to death [ Time Frame: 2007 - 2010 ]
  4. Ventilator Days [ Time Frame: 2007 - 2010 ]
  5. Ventilator-free days [ Time Frame: 2007 - 2010 ]
    Days alive and not requiring mechanical ventilation in first 28 days after ICU admission

  6. Intensive Care Unit (ICU)-free days [ Time Frame: 2007 - 2010 ]
    Days alive and not in the ICU in first 28 days after ICU admission

  7. Evidence-based care [ Time Frame: 2007 - 2010 ]

    % 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

  8. Discharge location among survivors [ Time Frame: 2007 - 2010 ]
  9. Intensive Care Unit (ICU)Length of Stay (LOS) [ Time Frame: 2007 - 2010 ]
  10. Hospital Length of Stay (LOS) [ Time Frame: 2007 - 2010 ]
  11. Hospital costs [ Time Frame: 2007 - 2010 ]
  12. Hospital charges [ Time Frame: 2007 - 2010 ]
  13. Patient Satisfaction Survey Results [ Time Frame: 2007 - 2010 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patients being seen at designated ICU during the time period being investigated.
Criteria

Inclusion Criteria:

  • Patients admitted to designated ICU between September 1, 2007 and September 30, 2010.

Exclusion Criteria:

  • Not admitted to designated ICU.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323816


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43015
Sponsors and Collaborators
Naeem Ali, MD
Investigators
Principal Investigator: Naeem Ali, M.D. Ohio State University

Publications:
Responsible Party: Naeem Ali, MD, Medical Director, Medical Intensive Care Unit (MICU);, Ohio State University
ClinicalTrials.gov Identifier: NCT01323816     History of Changes
Other Study ID Numbers: 2009H0145
First Posted: March 28, 2011    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes