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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02333396

Enrollment

442

Registered

2015-01-07

Start date

2015-04-06

Completion date

2017-04-28

Last updated

2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication

Keywords

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

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.

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).

Interventions

OTHERPICU 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.

OTHEREducational Brochure

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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)	3-5 weeks following PICU discharge	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

Secondary

Measure	Time frame	Description
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	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
Parental Decision Regret (Decision Regret Scale)	3-5 weeks after PICU discharge	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
Parental Anxiety (Anxiety SF8a)	3-5 weeks after PICU discharge	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.
Parental Depression (Depression SF8a)	3-5 weeks after PICU discharge	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.
Parental Impact of Event/Post-Traumatic Distress (Impact of Event Scale-revised)	3-5 weeks after PICU discharge	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
Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU)	3-5 weeks following PICU discharge	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
Parental Health-related Quality of Life (Global Health Scale) Mental	3-5 weeks after PICU discharge	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.
Parental Complicated Bereavement (Grief Scale)	3-5 weeks after PICU discharge	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
Parent Report of Healthcare Team Satisfaction (Collaboration and Satisfaction About Care Decisions Scale)	3-5 weeks after PICU Discharge	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
Parent Report of Healthcare Team Collaboration (Collaboration and Satisfaction About Care Decisions Scale)	3-5 weeks after PICU Discharge	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.
Parental Report of Acceptability and Perceived Effectiveness of PICU Supports (Likert-scale)	3-5 weeks after PICU Discharge	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
Parental Health-related Quality of Life (Global Health Scale) Physical	3-5 weeks after PICU discharge	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
PICU Supports Participants will receive the PICU Supports intervention. 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.	124
Educational Brochure Participants will receive an educational brochure about the pediatric intensive care unit. Educational Brochure: Parents will receive a short educational brochure with information about the pediatric intensive care unit.	117
Total	241

Baseline characteristics

Characteristic	Educational Brochure	Total	PICU Supports
Age, Continuous	36.4 years STANDARD_DEVIATION 8	35.5 years STANDARD_DEVIATION 7.9	34.7 years STANDARD_DEVIATION 7.6
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants	45 Participants	33 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants	182 Participants	84 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants	14 Participants	7 Participants
Race (NIH/OMB) Race American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Race Asian	9 Participants	12 Participants	3 Participants
Race (NIH/OMB) Race Black or African American	25 Participants	39 Participants	14 Participants
Race (NIH/OMB) Race More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Race Unknown or Not Reported	10 Participants	42 Participants	32 Participants
Race (NIH/OMB) Race White	73 Participants	148 Participants	75 Participants
Sex: Female, Male Female	89 Participants	191 Participants	102 Participants
Sex: Female, Male Male	24 Participants	43 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 124	0 / 117
other Total, other adverse events	0 / 124	0 / 117
serious Total, serious adverse events	0 / 124	0 / 117

Outcome results

Primary

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

Time frame: 3-5 weeks following PICU discharge

Arm	Measure	Value (MEAN)	Dispersion
PICU Supports	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)	60.35 Percentage of excellent scores	Standard Error 33.35
Educational Brochure	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)	56.09 Percentage of excellent scores	Standard Error 35.23

p-value: 0.4495% CI: [-5.77, 12.9]Mixed Models Analysis

Secondary

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.