Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Kelly Michelson
Previous Study | Return to List | Next Study

Improving Communication in the PICU: The Navigate Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02333396
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kelly Michelson, 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.

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).

Layout table for study information
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

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333396


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Kelly N Michelson, MD Ann & Robert H. Lurie Childrens Hospital of Chicago
Layout table for additonal 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    Key Record Dates
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