Improving Communication in the PICU: The Navigate Study
Communication
Bottom Line
View on ClinicalTrials.gov: NCT02333396 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PICU Supports (Other); Educational Brochure (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
60.35; 56.09 | 0.44 |
| SECONDARY Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU) |
86.63; 82.8 | 0.09 |
| SECONDARY Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire) |
85.86; 82.59 | 0.19 |
| SECONDARY Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire) |
85.86; 82.59 | 0.19 |
| SECONDARY Parental Decision Regret (Decision Regret Scale) |
12.61; 12.87 | 0.93 |
| SECONDARY Parental Anxiety (Anxiety SF8a) |
49.32; 49.68 | 0.79 |
| SECONDARY Parental Depression (Depression SF8a) |
47.71; 47.23 | — |
| SECONDARY Parental Impact of Event/Post-Traumatic Distress (Impact of Event Scale-revised) |
14.02; 12.93 | — |
| SECONDARY Parental Health-related Quality of Life (Global Health Scale) Physical |
48.42; 48.9 | 0.64 |
| SECONDARY Parental Health-related Quality of Life (Global Health Scale) Mental |
50.02; 50.92 | 0.39 |
| SECONDARY Parental Complicated Bereavement (Grief Scale) |
19; 19 | — |
| SECONDARY Parent Report of Healthcare Team Satisfaction (Collaboration and Satisfaction About Care Decisions Scale) |
12.81; 12.09 | 0.13 |
| SECONDARY Parent Report of Healthcare Team Collaboration (Collaboration and Satisfaction About Care Decisions Scale) |
44; 42 | 0.13 |
| SECONDARY Parental Report of Acceptability and Perceived Effectiveness of PICU Supports (Likert-scale) |
113 | — |
Summary
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.
Data sourced from ClinicalTrials.gov (NCT02333396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.