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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323816
• Other study ID #: 2009H0145
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: June 25, 2014
• Start date: March 2011
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3659
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not admitted to designated ICU.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Medically directed care
There is no research directed care. Patients are treated as medically indicated.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Naeem Ali, MD

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2007 Jun 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Intensive Care Unit (ICU) mortality		2007 - 2010	No
Secondary	Hospital mortality		2007 - 2010	No
Secondary	Time to death		2007 - 2010	No
Secondary	Ventilator Days		2007 - 2010	No
Secondary	Ventilator-free days	Days alive and not requiring mechanical ventilation in first 28 days after ICU admission	2007 - 2010	No
Secondary	Intensive Care Unit (ICU)-free days	Days alive and not in the ICU in first 28 days after ICU admission	2007 - 2010	No
Secondary	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	2007 - 2010	No
Secondary	Discharge location among survivors		2007 - 2010	No
Secondary	Intensive Care Unit (ICU)Length of Stay (LOS)		2007 - 2010	No
Secondary	Hospital Length of Stay (LOS)		2007 - 2010	No
Secondary	Hospital costs		2007 - 2010	No
Secondary	Hospital charges		2007 - 2010	No
Secondary	Patient Satisfaction Survey Results		2007 - 2010	No