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

Not Applicable

Completed

• Conditions: ICU Length of Stay
• Interventions: Behavioral: Primary intensivist and nurses

• Registration Number: NCT03364933
• Lead Sponsor: Columbia University

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 Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-07
• Study Start: 2018-02-01
• Primary Completion: 2020-02-03
• Study Completion: 2020-02-03
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Read More

Exclusion Criteria

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
PICU length of stay	Up to 2 years	Total number of days in which an individual stays in the PICU

Secondary Outcome Measures

Name	Time	Method
Family satisfaction	Up to 2 years	In order to assess family satisfaction, families of all PICU patients (with PICU lengths of stay \> 10 days) will be asked to complete a short anonymous questionnaire (Likert Scale) at the time of ICU discharge or within a few days when the patient is still hospitalized, if discharged late at night or over a weekend.
Provider satisfaction	Up to 2 years	In order assess provider satisfaction, all PICU attendings, fellows, and nurses will be verbally consented and asked to complete a short anonymous questionnaire (Likert Scale) at one of two time points-1) at the end of the study or 2) before the staff member leaves
Percentage of family meetings attended by a primary nurse	Up to 2 years	Number of meetings a nurse participated in divided by the number of meetings
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	Measured in days.
Time to tracheotomy in those who undergo a tracheotomy	Up to 2 years	Measured in days.
Incidence of nursing-related KEEPSAFE reports recorded after enrollment	Up to 2 years	total number of reports that are recorded.
Timing of involvement of Patient Care Services	Up to 2 years	Measured in days.
Incidence of ICU-acquired infections after enrollment	Up to 2 years	Total number of ICU-acquired infections
Number of documented family meetings	Up to 2 years	Total number of family meetings.
Incidence of unplanned re-admissions to a PICU within 48 hours of PICU discharge	Up to 2 years	Total number of unplanned re-admissions to a PICU.
Percentage of primary intensivists who meet with families	Up to 2 years	Measured by total number of meeting divided by the number of weeks after enrollment.
Total number of shifts that are not being covered by a primary nurse,	Up to 2 years	The Bice-Boxerman Continuity of Care Index will be used to measure continuity compliance in terms of the total number of shifts not covered by a primary nurse.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States