Improving Communication in the PICU: The Navigate Study

NCT02333396 | Completed Results DMC

• 1 other identifier: The Navigate Study
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Navigator; Intervention Study; Randomized Controlled Trial; Pediatric Intensive Care Unit; Decision Making

Outcome Measures

Primary Outcomes (1)

• Satisfaction With Decision Making (Percentage of "Excellent" Scores in the Decision Making Domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)

  Percentage of "excellent" scores in the decision making domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome

  3-5 weeks following PICU discharge

Secondary Outcomes (13)

• Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU)

  3-5 weeks following PICU discharge

• Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)

  3-5 weeks after PICU Discharge

• Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)

  3-5 weeks after PICU Discharge

• Parental Decision Regret (Decision Regret Scale)

  3-5 weeks after PICU discharge

• Parental Anxiety (Anxiety SF8a)

  3-5 weeks after PICU discharge

Study Arms (2)

PICU Supports

EXPERIMENTAL

Participants will receive the PICU Supports intervention.

Other: PICU Supports

Educational Brochure

ACTIVE COMPARATOR

Participants will receive an educational brochure about the pediatric intensive care unit.

Other: Educational Brochure

Interventions

PICU Supports OTHER

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.

PICU Supports

Educational Brochure OTHER

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

Educational Brochure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Case Patients
• patients \< 18 years of age admitted to the PICU
• parents are English or Spanish-speakers and who:
• are likely to require PICU care for at least 24 hours (as determined by the PICU attending physician) or
• have a Pediatric Index of Mortality 2 (PIM2) score ≥ 4% (a PIM2 score predicts risk of mortality based on clinical data collected at the time of admission to the PICU)
• Case patients will be included in the study if one of his/her parents agrees to participate in the study and signs a written consent form.
• Parents of case patients
• Parent of an eligible case patient.
• PICU attending gives permission to approach the parent about the study.
• Parent is an English or Spanish speaker.
• Parent provides written consent for participation.
• Healthcare Team Members for the pre-post assessment of team communication and focus group:
• This group will include as many clinicians in the following groups as possible (identified by the site principal investigator): PICU physicians (attendings and fellows); PICU bedside nurses; PICU Advance Practice Nurses (APNs); hospitalists; subspecialty physicians who consult on PICU patients; subspecialty APNs who consult on PICU patients; PICU respiratory therapist; PICU physical/occupational/speech therapists; and social workers (SWs), chaplains, and case managers who follow PICU patients.
• Healthcare team members for the written feedback/assessment of the intervention:
• HTMs caring for the case patient at the time of PICU discharge: (PICU attending; PICU fellow; social worker (if involved); chaplain (if involved); bedside nurse; PICU resident, APN or hospitalist; and one to two subspecialty attendings)

You may not qualify if:

• PICU attending does not give permission to approach the parent about the study.
• Parent is not an English or Spanish speaker.
• Parent does not provide written consent to participate.
• The case patient does not provide assent (if able to provide assent).
• Healthcare team member that does not regularly care for patients in the PICU.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

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

Chicago, Illinois, 60611, United States

Location

The University of Chicago Medicine Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• Ashworth RC, Malone JR, Franklin D, Sorce LR, Clayman ML, Frader J, White DB, Michelson KN. Associations of Patient and Parent Characteristics With Parental Decision Regret in the PICU: A Secondary Analysis of the 2015-2017 Navigate Randomized Comparative Trial. Pediatr Crit Care Med. 2024 Sep 1;25(9):795-803. doi: 10.1097/PCC.0000000000003534. Epub 2024 May 10.

  PMID: 38727516 DERIVED

• Tager JB, Hinojosa JT, LiaBraaten BM, Balistreri KA, Aniciete D, Charleston E, Frader JE, White DB, Clayman ML, Sorce LR, Davies WH, Rothschild CB, Michelson KN; Navigate Study Investigators. Challenges of Families of Patients Hospitalized in the PICU: A Preplanned Secondary Analysis From the Navigate Dataset. Pediatr Crit Care Med. 2024 Feb 1;25(2):128-138. doi: 10.1097/PCC.0000000000003385. Epub 2023 Oct 27.

  PMID: 37889100 DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Karen Rychlik, MS
• Organization: ChildrensMemorialH

krychlik@luriechildrens.org

(773) 755-6310

Study Officials

• Kelly N Michelson, MD

  Ann & Robert H. Lurie Childrens Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kelly Michelson, MD

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: January 7, 2015
• Study Start: April 6, 2015
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)