CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 442 enrolled
Drug / intervention
PICU Supports +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02333396
NCT02333396N/ACompleted

Improving Communication in the Pediatric Intensive Care Unit for Patients Facing Life-Changing Decisions: The Navigate Study

Ann & Robert H Lurie Children's Hospital of Chicago·interventional·Posted Jan 7, 2015·Updated Mar 26, 2025

In Brief

A clinical study evaluating PICU Supports and Educational Brochure for Communication. Completed, enrolled 442 participants across 2 sites.

Detailed Summary

The project seeks to study the use of an navigator-based intervention called "PICU Supports." The study will test the impact of PICU Supports during and after PICU discharge on parent outcomes (satisfaction with decision making, decision regret, anxiety, depression, post-traumatic stress, health-related quality of life, and complicated bereavement) and on parent and healthcare team member assessments of communication and team collaboration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCommunication
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 7, 2015
Enrollment StartApr 6, 2015
Primary CompletionApr 28, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.5 years ago

Interventions

PICU Supportsother

The PICU Supports intervention includes navigator activities and ancillary tools. The Navigator activities include: initial visits with the healthcare team members (HTMs) and parents; weekday visits with the parents and feedback to the HTMs as needed; coordination of weekly family meetings between the parents and HTMs; and support during transitions out of the unit. The ancillary tools include: a PICU handbook; a place for parents to keep track of events and their goals; a provider sheet to inform PICU HTMs about important parental issues, concerns or goals; a bedside communication log so parents know which non-PICU HTMs have visited; an end-of-life checklist; a bereavement packet for those whose child dies; and informational resources.

Educational Brochureother

Parents will receive a short educational brochure with information about the pediatric intensive care unit.