NCT03364933

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

November 28, 2017

Last Update Submit

July 24, 2020

Conditions

Keywords

ChildCritical IllnessLength of StaySatisfaction

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

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients 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.

Primary intensivist and nurses

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Critical IllnessPersonal Satisfaction

Interventions

Nurses

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Jeffrey Edwards, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

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

Locations