Improving Communication in the PICU: The Navigate Study

• ClinicalTrials.gov Identifier: NCT02333396
• Recruitment Status: Completed
• First Posted: January 7, 2015
• Last Update Posted: May 3, 2017
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Kelly Michelson, Ann & Robert H Lurie Children's Hospital of Chicago

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Communication	Other: PICU Supports; Other: Educational Brochure	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 506 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Improving Communication in the Pediatric Intensive Care Unit for Patients Facing Life-Changing Decisions: The Navigate Study
• Actual Study Start Date: April 6, 2015
• Actual Primary Completion Date: March 7, 2017
• Actual Study Completion Date: March 7, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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) [ Time Frame: 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

Secondary Outcome Measures :

1. 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) [ Time Frame: Participants will be followed for the duration of PICU admission, an expected average of 10 days ]
   Percentage of "excellent" scores in the decision making domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire
2. Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire) [ Time Frame: 3-5 weeks after PICU Discharge ]
   Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire
3. Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire) [ Time Frame: Participants will be followed for the duration of PICU admission, an expected average of 10 days ]
   Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire
4. Parental Decision Regret (Decision Regret Scale) [ Time Frame: 3-5 weeks after PICU discharge ]
   Score on the Decision Regret Scale, a 5-item Likert-scale measure of decision regret
5. Parental Decision Regret (Decision Regret Scale) [ Time Frame: Collected at the end of the PICU admission, an expected average of 10 days ]
   Score on the Decision Regret Scale, a 5-item Likert-scale measure of decision regret
6. Parental Anxiety (Anxiety SF8a) [ Time Frame: 3-5 weeks after PICU discharge ]
   Score on the Anxiety SF8a, a 8-item Likert-scale measure of anxiety
7. Parental Anxiety (Anxiety SF8a) [ Time Frame: Collected at the end of the PICU admission, an expected average of 10 days ]
   Score on the Anxiety SF8a, a 8-item Likert-scale measure of anxiety
8. Parental Depression (Depression SF8a) [ Time Frame: 3-5 weeks after PICU discharge ]
   Score on the Depression SF8a, a 8-item Likert-scale measure of depression
9. Parental Depression (Depression SF8a) [ Time Frame: Collected at the end of the PICU admission, an expected average of 10 days ]
   Score on the Depression SF8a, a 8-item Likert-scale measure of depression
10. Parental Impact of event/Post-Traumatic Distress (Impact of Event Scale-revised) [ Time Frame: 3-5 weeks after PICU discharge ]
    Score on the Impact of Event Scale-revised, a 22-item Likert-scale measure of post-traumatic distress
11. Parental Impact of event/Post-Traumatic Distress (Impact of Event Scale-revised) [ Time Frame: Collected at the end of the PICU admission, an expected average of 10 days ]
    Score on the Impact of Event Scale-revised, a 22-item Likert-scale measure of post-traumatic distress
12. Parental Health-related Quality of Life (Global Health scale) [ Time Frame: 3-5 weeks after PICU discharge ]
    Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life
13. Parental Health-related Quality of Life (Global Health scale) [ Time Frame: Collected at the end of the PICU admission, an expected average of 10 days ]
    Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life
14. Parental Complicated Bereavement (Grief Scale) [ Time Frame: 3-5 weeks after PICU discharge ]
    Score on the Index of complicated Grief Scale, a 19-item Likert-scale measure of complicated grief
15. Parental assessment of healthcare team communication with parents [ Time Frame: Participants will be followed for the duration of PICU admission, an expected average of 10 days ]
    Score on the Communication Assessment Tool, a 14-item Likert-scale measure of patient-provider communication
16. Parental assessment of healthcare team collaboration (Satisfaction about Care Decisions) [ Time Frame: 3-5 weeks after PICU discharge ]
    Score of the Collaboration and Satisfaction about Care Decisions scale, a 9-item Likert-scale measure of healthcare team communication in ICUs
17. Parental assessment of healthcare team collaboration (Collaboration and Satisfaction about Care Decisions scale) [ Time Frame: Participants will be followed for the duration of PICU admission, an expected average of 10 days ]
    Score of the Collaboration and Satisfaction about Care Decisions scale, a 9-item Likert-scale measure of healthcare team communication in ICUs
18. Healthcare team assessment of healthcare team collaboration (Collaboration and Satisfaction about Care Decisions scale) [ Time Frame: At the end of patient recruitment, expected length of patient recruitment 18 months ]
    Score of the Collaboration and Satisfaction about Care Decisions scale, a 9-item Likert-scale measure of healthcare team communication in ICUs
19. Healthcare team assessment of healthcare team collaboration (Collaboration and Satisfaction about Care Decisions scale) [ Time Frame: Collected at the end of the PICU admission, an expected average of 10 days ]
    Score of the Collaboration and Satisfaction about Care Decisions scale, a 9-item Likert-scale measure of healthcare team communication in ICUs
20. Parental report of acceptability and perceived effectiveness of PICU Supports (Likert-scale) [ Time Frame: 3-5 weeks after PICU Discharge ]
    Likert-scale items measuring perceived effectiveness and acceptability of the PICU Supports intervention
21. Parental report of acceptability and perceived effectiveness of PICU Supports (Likert-scale) [ Time Frame: Collected at the end of the PICU admission, an expected average of 10 days ]
    Likert-scale items measuring perceived effectiveness and acceptability of the PICU Supports intervention
22. Healthcare team members report of acceptability and perceived effectiveness of PICU Supports (Likert-scale) [ Time Frame: Collected at the end of the PICU admission, an expected average of 10 days ]
    Likert-scale items measuring perceived effectiveness and acceptability of the PICU Supports intervention

Other Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Illinois

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

The University of Chicago Medicine Comer Children's Hospital

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Kelly N Michelson, MD; Ann & Robert H. Lurie Childrens Hospital of Chicago

More Information

• Responsible Party: Kelly Michelson, Kelly Michelson, MD, Ann & Robert H Lurie Children's Hospital of Chicago
• ClinicalTrials.gov Identifier: NCT02333396
• Other Study ID Numbers: The Navigate Study
• First Posted: January 7, 2015
• Last Update Posted: May 3, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Kelly Michelson, Ann & Robert H Lurie Children's Hospital of Chicago:

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