Improving Communication in the PICU: The Navigate Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-06

Study Completion Date

2017-04-28

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PICU Supports

Participants will receive the PICU Supports intervention.

Group Type EXPERIMENTAL

PICU Supports

Intervention Type 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.

Educational Brochure

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

Group Type ACTIVE_COMPARATOR

Educational Brochure

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Educational Brochure

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No