Clinical trial NCT02333396: Improving Communication in the PICU: The Navigate Study
Official title: Improving Communication in the Pediatric Intensive Care Unit for Patients Facing Life-Changing Decisions: The Navigate Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Keywords: Navigator
Intervention Study
Randomized Controlled Trial
Pediatric Intensive Care Unit
Decision Making
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-01-07
Enrollment: 442
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 3-5 weeks following PICU discharge
Secondary outcomes:
measure: Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU)
timeFrame: 3-5 weeks following PICU discharge
measure: Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)
timeFrame: 3-5 weeks after PICU Discharge
measure: Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)
timeFrame: 3-5 weeks after PICU Discharge
measure: Parental Decision Regret (Decision Regret Scale)
timeFrame: 3-5 weeks after PICU discharge
measure: Parental Anxiety (Anxiety SF8a)
timeFrame: 3-5 weeks after PICU discharge
measure: Parental Depression (Depression SF8a)
timeFrame: 3-5 weeks after PICU discharge
measure: Parental Impact of Event/Post-Traumatic Distress (Impact of Event Scale-revised)
timeFrame: 3-5 weeks after PICU discharge
measure: Parental Health-related Quality of Life (Global Health Scale) Physical
timeFrame: 3-5 weeks after PICU discharge
measure: Parental Health-related Quality of Life (Global Health Scale) Mental
timeFrame: 3-5 weeks after PICU discharge
measure: Parental Complicated Bereavement (Grief Scale)
timeFrame: 3-5 weeks after PICU discharge
measure: Parent Report of Healthcare Team Satisfaction (Collaboration and Satisfaction About Care Decisions Scale)
timeFrame: 3-5 weeks after PICU Discharge
measure: Parent Report of Healthcare Team Collaboration (Collaboration and Satisfaction About Care Decisions Scale)
timeFrame: 3-5 weeks after PICU Discharge
measure: Parental Report of Acceptability and Perceived Effectiveness of PICU Supports (Likert-scale)
timeFrame: 3-5 weeks after PICU Discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine Comer Children's Hospital
state: Illinois
Study officials:
affiliation: Ann & Robert H. Lurie Childrens Hospital of Chicago
name: Kelly N Michelson, MD
role: PRINCIPAL_INVESTIGATOR
References: