NCT04298281

Brief Summary

Multidisciplinary experts from two Pediatric Intensive Care Units (PICUs), used an iterative modified Delphi process to develop and refine criteria for determining PICU patients for whom a family care conference would be beneficial. In this study the investigators will assess the use of those criteria as a trigger to offer parents of PICU patients a family care conference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
378

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

March 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

March 2, 2020

Last Update Submit

December 17, 2024

Conditions

Critical Illness

Keywords

PediatricsFamily Care ConferencesFamily Meetings

Outcome Measures

Primary Outcomes (1)

  • Family Care Conference Criteria Sensitivity

    Sensitivity of our Family Care Conference Criteria. Sensitivity can range from 0% - 100%

    Through PICU admission, an average of 3.5 days and up to 3 months

Secondary Outcomes (1)

  • Parents' views of PICU Family care conference based on survey responses

    Through PICU admission, an average of 3.5 days and up to 3 months

Study Arms (2)

Parents of patients who have a family care conference criteria

These will be parents of patient who have one of our defined family care conference criteria

Parents of patients who do not have a family care conference criteria

These will be parents of patients who do not have one our defined family care conference criteria

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* Pediatric Intensive Care Unit Patients * Parents of Pediatric Intensive Care Unit Patients

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ann Robert Lurie children's hospital

Chicago, Illinois, 60611, United States

Location

Advocate Lutheran General Children's Hospital

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kelly N Michelson, MD, MPH

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician, Ann & Robert H. Lurie Children's Hospital of Chicago

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 6, 2020

Study Start

November 30, 2020

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

December 18, 2024

Record last verified: 2024-12

Locations

US(2)