- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333396
Improving Communication in the PICU: The Navigate Study
Improving Communication in the Pediatric Intensive Care Unit for Patients Facing Life-Changing Decisions: The Navigate Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, United States, 60637
- The University of Chicago Medicine Comer Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PICU Supports
Participants will receive the PICU Supports intervention.
|
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.
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Active Comparator: Educational Brochure
Participants will receive an educational brochure about the pediatric intensive care unit.
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Parents will receive a short educational brochure with information about the pediatric intensive care unit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Percentage of "excellent" scores in the decision making domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire
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3-5 weeks following PICU discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Participants will be followed for the duration of PICU admission, an expected average of 10 days
|
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
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Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire
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3-5 weeks after PICU Discharge
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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
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Participants will be followed for the duration of PICU admission, an expected average of 10 days
|
Parental Decision Regret (Decision Regret Scale)
Time Frame: 3-5 weeks after PICU discharge
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Score on the Decision Regret Scale, a 5-item Likert-scale measure of decision regret
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3-5 weeks after PICU discharge
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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
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Collected at the end of the PICU admission, an expected average of 10 days
|
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
|
3-5 weeks after PICU discharge
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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
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Collected at the end of the PICU admission, an expected average of 10 days
|
Parental Depression (Depression SF8a)
Time Frame: 3-5 weeks after PICU discharge
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Score on the Depression SF8a, a 8-item Likert-scale measure of depression
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3-5 weeks after PICU discharge
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Parental Depression (Depression SF8a)
Time Frame: Collected at the end of the PICU admission, an expected average of 10 days
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Score on the Depression SF8a, a 8-item Likert-scale measure of depression
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Collected at the end of the PICU admission, an expected average of 10 days
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Parental Impact of event/Post-Traumatic Distress (Impact of Event Scale-revised)
Time Frame: 3-5 weeks after PICU discharge
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Score on the Impact of Event Scale-revised, a 22-item Likert-scale measure of post-traumatic distress
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3-5 weeks after PICU discharge
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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
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Score on the Impact of Event Scale-revised, a 22-item Likert-scale measure of post-traumatic distress
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Collected at the end of the PICU admission, an expected average of 10 days
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Parental Health-related Quality of Life (Global Health scale)
Time Frame: 3-5 weeks after PICU discharge
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Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life
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3-5 weeks after PICU discharge
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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
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Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life
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Collected at the end of the PICU admission, an expected average of 10 days
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Parental Complicated Bereavement (Grief Scale)
Time Frame: 3-5 weeks after PICU discharge
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Score on the Index of complicated Grief Scale, a 19-item Likert-scale measure of complicated grief
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3-5 weeks after PICU discharge
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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
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Score on the Communication Assessment Tool, a 14-item Likert-scale measure of patient-provider communication
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Participants will be followed for the duration of PICU admission, an expected average of 10 days
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Parental assessment of healthcare team collaboration (Satisfaction about Care Decisions)
Time Frame: 3-5 weeks after PICU discharge
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Score of the Collaboration and Satisfaction about Care Decisions scale, a 9-item Likert-scale measure of healthcare team communication in ICUs
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3-5 weeks after PICU discharge
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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
|
Participants will be followed for the duration of PICU admission, an expected average of 10 days
|
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
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Score of the Collaboration and Satisfaction about Care Decisions scale, a 9-item Likert-scale measure of healthcare team communication in ICUs
|
At the end of patient recruitment, expected length of patient recruitment 18 months
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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
|
Collected at the end of the PICU admission, an expected average of 10 days
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Parental report of acceptability and perceived effectiveness of PICU Supports (Likert-scale)
Time Frame: 3-5 weeks after PICU Discharge
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Likert-scale items measuring perceived effectiveness and acceptability of the PICU Supports intervention
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3-5 weeks after PICU Discharge
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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
|
Collected at the end of the PICU admission, an expected average of 10 days
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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
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Likert-scale items measuring perceived effectiveness and acceptability of the PICU Supports intervention
|
Collected at the end of the PICU admission, an expected average of 10 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Assessment of fidelity to the PICU Support intervention using documentation of a priori determined key components of PICU Supports
|
Participants will be followed for the duration of PICU admission, an expected average of 10 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kelly N Michelson, MD, Ann & Robert H. Lurie Childrens Hospital of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- The Navigate Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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