Improving Communication in the PICU: The Navigate Study

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

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 Overview

• Status: Completed
• Conditions: Communication
• Intervention / Treatment: Other: PICU Supports; Other: Educational Brochure

Detailed Description

Parents of children admitted to the PICU often face challenging decisions. Research demonstrates deficiencies in communication in the PICU which could impact decision making. This study team has developed a navigator-based intervention call PICU Supports. PICU Supports aims to provide the following types of support to parents of patients in the PICU: emotional; communication (between healthcare team members and parents/families as well as among healthcare team members ); decision making; transitions out of the PICU (i.e. discharge transitions to a non-PICU hospital bed, a long term care facility, or home); and information. Support is accomplished by navigator engagement with parents and healthcare team members and the guided use of navigator supported ancillary tools provided to parents and healthcare team members as needed. During the patient's PICU stay, the navigator activities and use of ancillary tools is directed by the family's needs. Thus PICU Supports uses a predefined framework of activities and tools to provide individualized support directed by the needs of the parent and the patient situation. This research will test PICU Supports in the clinical setting. This will be accomplished by conducting a pilot study of PICU Supports at Ann & Robert H. Lurie Children's Hospital of Chicago (Lurie Children's Hospital), followed by a randomized controlled trial (RCT) comparing the intervention, PICU Supports, to a control, parental receipt of an educational brochure. The RCT will be conducted at Lurie Children's Hospital and at University of Chicago Medicine Comer Children's Hospital (Comer Children's Hospital).

• Study Type: Interventional
• Enrollment (Actual): 442
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medicine Comer Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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)

Exclusion Criteria:

Exclusion criteria for parents of case patients:

• 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).

Exclusion criteria for Healthcare Team members:

-Healthcare team member that does not regularly care for patients in the PICU.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PICU Supports; Participants will receive the PICU Supports intervention.	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.
Active Comparator: Educational Brochure; Participants will receive an educational brochure about the pediatric intensive care unit.	Other: Educational Brochure; Parents will receive a short educational brochure with information about the pediatric intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU)	Measures satisfaction of family who have a child admitted to the Pediatric intensive care unit; Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire mean score, range 0-100, higher score is the better outcome	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)	Subscale: Satisfaction with Care Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome	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)	Subscale: Satisfaction with Decision Making Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome	3-5 weeks after PICU Discharge
Parental Decision Regret (Decision Regret Scale)	Score on the Decision Regret Scale, a 5-item Likert-scale measure of decision regret; minimum=0, maximum=100; higher score indicates more decision regret	3-5 weeks after PICU discharge
Parental Anxiety (Anxiety SF8a)	Score on the Anxiety Short Form8a, a 8-item Likert-scale measure of anxiety, the higher the score, the worst the anxiety, T-score range of 37.1 - 83.1. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average.	3-5 weeks after PICU discharge
Parental Depression (Depression SF8a)	Score on the Depression; Depression Short Form 8a, a 8-item Likert-scale measure of depression; the higher the score, the worst the depression, T-score range of 38.2 - 81.3. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average.	3-5 weeks after PICU discharge
Parental Impact of Event/Post-Traumatic Distress (Impact of Event Scale-revised)	A measure of post-traumatic distress; Score on the Impact of Event Scale-revised, a 22-item Likert-scale measure of post-traumatic distress; scale range from 0 - 88; higher numbers mean higher trauma or distress; units on a scale	3-5 weeks after PICU discharge
Parental Health-related Quality of Life (Global Health Scale) Physical	Measure of global physical health; Physical - Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life; the higher the score the worse global health, t-score range of 16.2 - 67.7. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average.	3-5 weeks after PICU discharge
Parental Health-related Quality of Life (Global Health Scale) Mental	Measure of Global Mental Health; Mental - Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life; high scores indicate worse mental health; T-score range 21.1 - 67.6. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average.	3-5 weeks after PICU discharge
Parental Complicated Bereavement (Grief Scale)	Measure of complicated grief in parents after their child's death; Score on the Index of complicated Grief Scale, a 19-item Likert-scale measure of complicated grief; minimum 0, maximum 74; higher numbers mean more complicate grief	3-5 weeks after PICU discharge
Parent Report of Healthcare Team Satisfaction (Collaboration and Satisfaction About Care Decisions Scale)	Measure of Satisfaction with Healthcare team collaboaration Subscale Collaboration Satisfaction Score of the Collaboration and Satisfaction about Care Decisions scale, 2 items on a 9-item Likert-scale measure of healthcare team communication satisfaction in ICUs, Score range from 2 - 14 with higher numbers meaning more satisfaction	3-5 weeks after PICU Discharge
Parent Report of Healthcare Team Collaboration (Collaboration and Satisfaction About Care Decisions Scale)	Subscale Collaboration Score of the Collaboration and Satisfaction about Care Decisions scale, 7 items on a a 9-item Likert-scale measure of healthcare team communication in ICUs, scale range from 7 - 49. Higher numbers more collaboration.	3-5 weeks after PICU Discharge
Parental Report of Acceptability and Perceived Effectiveness of PICU Supports (Likert-scale)	Likert-scale items measuring perceived effectiveness and acceptability of the PICU Supports intervention. One likert scale item based on previous work. White DB, Cua SM, Walk R, et al. Nurse-led intervention to improve surrogate decision making for patients with advanced critical illness. Am J Crit Care. Nov 2012;21(6):396-409. How well did the PICU Supports help with communication in the PICU? scale "Not at all helpful" "Not very helpful" "Somewhat helpful" "Extremely Helpful" "Unable to assess" Scored based on percentage of participants who responded "Somewhat Helpful" or Extremely Helpful"	3-5 weeks after PICU Discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of PICU Supports ( using documentation of a priori determined key components of PICU Supports)	Assessment of fidelity to the PICU Support intervention using documentation of a priori determined key components of PICU Supports	Participants will be followed for the duration of PICU admission, an expected average of 10 days

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Kelly N Michelson, MD, Ann & Robert H. Lurie Childrens Hospital of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2015
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: January 2, 2015
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimated): January 7, 2015

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Decision Making; Randomized Controlled Trial; Intervention Study; Navigator; Pediatric Intensive Care Unit
• Other Study ID Numbers: The Navigate Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO