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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naeem Ali, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01323816
First received: March 24, 2011
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 Intervention
Critical Illness
Other: Medically directed care

Study Type: Observational
Study Design: 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

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Life-years hospital costs [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
    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:
  • Intensive Care Unit (ICU) mortality [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
  • Time to death [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
  • Ventilator Days [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
  • Ventilator-free days [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
    Days alive and not requiring mechanical ventilation in first 28 days after ICU admission

  • Intensive Care Unit (ICU)-free days [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
    Days alive and not in the ICU in first 28 days after ICU admission

  • Evidence-based care [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]

    % 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

  • Discharge location among survivors [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
  • Intensive Care Unit (ICU)Length of Stay (LOS) [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
  • Hospital Length of Stay (LOS) [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
  • Hospital costs [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
  • Hospital charges [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]
  • Patient Satisfaction Survey Results [ Time Frame: 2007 - 2010 ] [ Designated as safety issue: No ]

Enrollment: 3659
Study Start Date: March 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Naeem Ali, MD, Medical Director, Medical Intensive Care Unit (MICU);, The Ohio State University
ClinicalTrials.gov Identifier: NCT01323816     History of Changes
Other Study ID Numbers: 2009H0145
Study First Received: March 24, 2011
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014