Primary Intensivists and Primary Nurses to Decrease Pediatric ICU Length of Stay
PIPRNs
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 7, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2020
CompletedJuly 27, 2020
July 1, 2020
2 years
November 28, 2017
July 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PICU length of stay
Total number of days in which an individual stays in the PICU
Up to 2 years
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
Primary intensivist and nurses
EXPERIMENTALPatients randomized to the experimental arm will have a primary intensivist and a team of primary nurses assigned to them.
Control
NO INTERVENTIONPatients who are randomized to the control group will receive usual care and not be assigned a primary intensivist or nurses.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Edwards, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 7, 2017
Study Start
February 1, 2018
Primary Completion
February 3, 2020
Study Completion
February 3, 2020
Last Updated
July 27, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share