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Improving Communication in the PICU: The Navigate Study

NCT02333396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2025-03-26

Study results available
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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.

Conditions

  • Communication

Interventions

OTHER

PICU Supports

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.

OTHER

Educational Brochure

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

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Kelly N Michelson, MD · Ann & Robert H. Lurie Childrens Hospital of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-06
Primary Completion
2017-04-28
Completion
2017-04-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02333396 on ClinicalTrials.gov