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Clinical Trials/NCT03364933
NCT03364933CompletedNot Applicable

Primary Intensivists and Primary Nurses to Decrease Pediatric ICU Length of Stay

Columbia University1 site in 1 country200 target enrollmentStarted: February 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Locations
1
Primary Endpoint
PICU length of stay

Study Overview

Brief Summary

This is a randomized control trial of PICU patients admitted for 7 days and expected to remain for at least another 3 days and who have a complex chronic condition. Patients will be randomized to usual care or usual care plus a primary intensivist and group of primary nurses (to facilitate passing of important patient information and informed, expedited decision-making). The primary research question is whether having a primary intensivist and nurses decreases PICU length of stay.

Detailed Description

Long-stay intensive care unit (ICU) patients, or children who require prolonged hospitalization in the pediatric ICU (PICU), represent a minority of PICU patients but have a disproportionate impact on hospital resources and unfavorable outcomes, including morbidity, mortality, and repeated critical illness. These patients and their families have multifaceted needs (eg, tailored communication) that pose unique challenges to PICU providers and the parent-provider relationship. These experiences and needs are compounded and complicated by the transitory care that is typically provided by PICU. This transitory care may contribute to 1) patient/family dissatisfaction; 2) ineffective passing of important information day to day and week to week; and 3) delayed decision-making. These latter two potential consequences may, in turn, contribute to prolonged length of stay (LOS).

For these reasons, the investigators propose a randomized control trial to test whether primary intensivists and primary nurses can decrease PICU LOS for long-stay patients. A primary intensivist is one that remains a consistent physician-presence for the patient/family and PICU team throughout the child's PICU stay, despite changes in the intensivist(s) who orchestrates day-to-day management. Primary nurses are a team of PICU nurses who provide the all/most of the bedside care to the child. The investigators hypothesize that the long-stay PICU patients who are randomized to receive primary intensivists and nurses will have a statistically lower LOS than those patients who do not.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •PICU patients of any age who
  • •have a complex chronic condition
  • •have been admitted to the PICU for one week and are predicted by the PICU attending to continue to be admitted for at least another 3 days.

Exclusion Criteria

  • Not provided

Arms & Interventions

Primary intensivist and nurses

Experimental

Patients randomized to the experimental arm will have a primary intensivist and a team of primary nurses assigned to them.

Intervention: Primary intensivist and nurses (Behavioral)

Control

No Intervention

Patients who are randomized to the control group will receive usual care and not be assigned a primary intensivist or nurses.

Outcomes

Primary Outcomes

PICU length of stay

Time Frame: Up to 2 years

Total number of days in which an individual stays in the PICU

Secondary Outcomes

  • Family satisfaction(Up to 2 years)
  • Provider satisfaction(Up to 2 years)
  • Percentage of family meetings attended by a primary nurse(Up to 2 years)
  • Duration of invasive mechanical ventilation in those patients without chronic respiratory failure and who are on invasive mechanical ventilation from the time of enrollment(Up to 2 years)
  • Time to tracheotomy in those who undergo a tracheotomy(Up to 2 years)
  • Incidence of nursing-related KEEPSAFE reports recorded after enrollment(Up to 2 years)
  • Timing of involvement of Patient Care Services(Up to 2 years)
  • Incidence of ICU-acquired infections after enrollment(Up to 2 years)
  • Number of documented family meetings(Up to 2 years)
  • Incidence of unplanned re-admissions to a PICU within 48 hours of PICU discharge(Up to 2 years)
  • Percentage of primary intensivists who meet with families(Up to 2 years)
  • Total number of shifts that are not being covered by a primary nurse,(Up to 2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeffrey D. Edwards

Assistant Professor of Pediatrics

Columbia University

Study Sites (1)

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