NCT01323816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,659

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 27, 2014

Status Verified

June 1, 2014

Enrollment Period

3.2 years

First QC Date

March 24, 2011

Last Update Submit

June 25, 2014

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • 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

    2007 - 2010

Secondary Outcomes (13)

  • Intensive Care Unit (ICU) mortality

    2007 - 2010

  • Hospital mortality

    2007 - 2010

  • Time to death

    2007 - 2010

  • Ventilator Days

    2007 - 2010

  • Ventilator-free days

    2007 - 2010

  • +8 more secondary outcomes

Study Arms (2)

Traditional

ICU staffed by a resident, pulmonary fellow and attending

Other: Medically directed care

Non-Traditional

ICU staffed by Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending

Other: Medically directed care

Interventions

Medically directed careOTHER

There is no research directed care. Patients are treated as medically indicated.

Non-TraditionalTraditional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any patients being seen at designated ICU during the time period being investigated.

You may qualify if:

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

You may not qualify if:

  • Not admitted to designated ICU.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43015, United States

Location

Related Publications (6)

  • 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.

    PMID: 15640637BACKGROUND

  • 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.

    PMID: 15187502BACKGROUND

  • 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.

    PMID: 18766097BACKGROUND

  • 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.

    PMID: 8951267BACKGROUND

  • 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.

    PMID: 12413375BACKGROUND

  • 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.

    PMID: 17556721BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Naeem Ali, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director, Medical Intensive Care Unit (MICU);

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 28, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 27, 2014

Record last verified: 2014-06

Locations

US(1)