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CompletedNCT03364933PIPRNsUpdated Jul 27, 2020

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

An interventional study of Primary intensivist and nurses in ICU Length of Stay, sponsored by Columbia University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-07-27.

Sponsored by Columbia University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • ICU Length of Stay

Keywords

  • Child
  • Critical Illness
  • Length of Stay
  • Satisfaction
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

-

04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Primary intensivist and nurses

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

    Behavioral: Primary intensivist and nurses

  • No intervention
    Control

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

Interventions

  • BehavioralPrimary intensivist and nurses

    Primary intensivist will have no active role in the daily management of patients. The primary intensivist should facilitate decision-making, be a liaison between the patient/family and PICU team, and be a resource of information for all. Responsibilities of primary intensivist: * Weekly check-in with and availability to patient/family * Attendance at family meetings * Availability to PICU team Primary nurses will be a team of up to 7 ICU nurses who will provide as much of the bedside care as possible. Responsibilities of primary nurses: * Maintain a primary nurse binder (paper format) for on-going communication about the patient among the team members; it will be their discretion what is information is communicated. * The Primary Nurse or delegate will be involved in all team/family meetings and will be expected/given an opportunity to speak during these meetings.

05

What researchers measure

Primary outcomes

  1. PICU length of stay

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

    Time frame: Up to 2 years

Secondary outcomes

  1. Family satisfaction

    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.

    Time frame: Up to 2 years

  2. Provider satisfaction

    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

    Time frame: Up to 2 years

  3. Percentage of family meetings attended by a primary nurse

    Number of meetings a nurse participated in divided by the number of meetings

    Time frame: Up to 2 years

  4. Duration of invasive mechanical ventilation in those patients without chronic respiratory failure and who are on invasive mechanical ventilation from the time of enrollment

    Measured in days.

    Time frame: Up to 2 years

  5. Time to tracheotomy in those who undergo a tracheotomy

    Measured in days.

    Time frame: Up to 2 years

  6. Incidence of nursing-related KEEPSAFE reports recorded after enrollment

    total number of reports that are recorded.

    Time frame: Up to 2 years

  7. Timing of involvement of Patient Care Services

    Measured in days.

    Time frame: Up to 2 years

  8. Incidence of ICU-acquired infections after enrollment

    Total number of ICU-acquired infections

    Time frame: Up to 2 years

  9. Number of documented family meetings

    Total number of family meetings.

    Time frame: Up to 2 years

  10. Incidence of unplanned re-admissions to a PICU within 48 hours of PICU discharge

    Total number of unplanned re-admissions to a PICU.

    Time frame: Up to 2 years

  11. Percentage of primary intensivists who meet with families

    Measured by total number of meeting divided by the number of weeks after enrollment.

    Time frame: Up to 2 years

  12. Total number of shifts that are not being covered by a primary nurse,

    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.

    Time frame: Up to 2 years

06

Study locations

1 site
  • Columbia University Medical Center
    New York, New York 10032, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03364933
Lead sponsor
Columbia University
Responsible party
Jeffrey D. Edwards (Assistant Professor of Pediatrics, Columbia University) — Principal investigator
First posted
Dec 7, 2017
Start date
Feb 1, 2018
Primary completion
Feb 3, 2020
Completion
Feb 3, 2020
Last update
Jul 27, 2020

Study contacts

Jeffrey Edwards, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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