Improving Communication in the PICU: The Navigate Study

Not Applicable

Completed

Conditions: Communication

Interventions: Other: PICU Supports
Other: Educational Brochure

Registration Number: NCT02333396

Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 442

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICU Supports	PICU Supports	Participants will receive the PICU Supports intervention.
Educational Brochure	Educational Brochure	Participants will receive an educational brochure about the pediatric intensive care unit.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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
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
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.
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"

Trial Locations

Locations (2): Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, United States
The University of Chicago Medicine Comer Children's Hospital
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Chicago, Illinois, United States