Ann & Robert H Lurie Children's Hospital of Chicago
Who can join
Eligibility, any sex, with Communication. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· 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
Group
Value
95% CI
PICU Supports
60.35
± 33.35
Educational Brochure
56.09
± 35.23
Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU)Secondary· 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
Group
Value
95% CI
PICU Supports
86.63
± 13.28
Educational Brochure
82.8
± 17.6
Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)Secondary· 3-5 weeks after PICU Discharge
Subscale: Satisfaction with Care Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome
Group
Value
95% CI
PICU Supports
87.22
± 13.43
Educational Brochure
82.94
± 17.59
Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)Secondary· 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
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
Group
Value
95% CI
PICU Supports
12.61
± 19.89
Educational Brochure
12.87
± 16.09
Parental Anxiety (Anxiety SF8a)Secondary· 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.
Group
Value
95% CI
PICU Supports
49.32
± 9.78
Educational Brochure
49.68
± 10.26
Parental Depression (Depression SF8a)Secondary· 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.
Group
Value
95% CI
PICU Supports
47.71
± 8.33
Educational Brochure
47.23
± 9.18
Parental Impact of Event/Post-Traumatic Distress (Impact of Event Scale-revised)Secondary· 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
Group
Value
95% CI
PICU Supports
14.02
± 16.81
Educational Brochure
12.93
± 14.32
Parental Health-related Quality of Life (Global Health Scale) PhysicalSecondary· 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.
Group
Value
95% CI
PICU Supports
48.42
± 7.50
Educational Brochure
48.9
± 7.76
Parental Health-related Quality of Life (Global Health Scale) MentalSecondary· 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.
Group
Value
95% CI
PICU Supports
50.02
± 8.01
Educational Brochure
50.92
± 7.37
Parental Complicated Bereavement (Grief Scale)Secondary· 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
Group
Value
95% CI
PICU Supports
19
19 – 19
Educational Brochure
19
19 – 19
Parent Report of Healthcare Team Satisfaction (Collaboration and Satisfaction About Care Decisions Scale)Secondary· 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
Group
Value
95% CI
PICU Supports
12.81
± 2.01
Educational Brochure
12.09
± 2.61
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago
Last refreshed: 26 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02333396.