Trial Outcomes & Findings for Decision Making Support for Parents and Caregivers (NCT NCT05733975)
NCT ID: NCT05733975
Last Updated: 2025-03-18
Results Overview
Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
At enrollment (approximately 9 months)
Results posted on
2025-03-18
Participant Flow
Participants were recruited based on assessment of infant eligibility and approval from primary physician. Parental consent was obtained based on eligible participants. The first participant was enrolled on May 2, 2023 and the last participant was enrolled January 29, 2024.
Participant milestones
| Measure |
Critically Ill Infants
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
Parent(s) of Critically Ill Infant
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
Clinicians
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
44
|
30
|
|
Overall Study
COMPLETED
|
30
|
42
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This row includes the infant population only. Infant age at enrollment is reported in days. Adults are not reported in this section.
Baseline characteristics by cohort
| Measure |
Critically Ill Infants
n=30 Participants
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
Parent(s) of Critically Ill Infant
n=43 Participants
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
Clinicians
n=30 Participants
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age at enrollment
|
20 days
n=30 Participants • This row includes the infant population only. Infant age at enrollment is reported in days. Adults are not reported in this section.
|
—
|
—
|
20 days
n=30 Participants • This row includes the infant population only. Infant age at enrollment is reported in days. Adults are not reported in this section.
|
|
Age, Continuous
|
—
|
30.0 years
n=43 Participants • This row includes the adult population only (parents and clinicians). Infants are not reported in this section.
|
41.0 years
n=30 Participants • This row includes the adult population only (parents and clinicians). Infants are not reported in this section.
|
34.0 years
n=73 Participants • This row includes the adult population only (parents and clinicians). Infants are not reported in this section.
|
|
Sex: Female, Male
Female
|
10 Participants
n=30 Participants
|
30 Participants
n=43 Participants
|
22 Participants
n=30 Participants
|
62 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=30 Participants
|
13 Participants
n=43 Participants
|
8 Participants
n=30 Participants
|
41 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=30 Participants
|
4 Participants
n=43 Participants
|
2 Participants
n=30 Participants
|
10 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=30 Participants
|
39 Participants
n=43 Participants
|
28 Participants
n=30 Participants
|
93 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=30 Participants
|
2 Participants
n=43 Participants
|
2 Participants
n=30 Participants
|
5 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=30 Participants
|
15 Participants
n=43 Participants
|
3 Participants
n=30 Participants
|
33 Participants
n=103 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=30 Participants
|
19 Participants
n=43 Participants
|
25 Participants
n=30 Participants
|
57 Participants
n=103 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=30 Participants
|
4 Participants
n=43 Participants
|
0 Participants
n=30 Participants
|
5 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
3 Participants
n=43 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=103 Participants
|
PRIMARY outcome
Timeframe: At enrollment (approximately 9 months)Population: Eligible critically ill infants.
Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%.
Outcome measures
| Measure |
Critically Ill Infants
n=54 Participants
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
Clinicians
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
|---|---|---|
|
Enrollment Rate (Critically Ill Infants)
Not enrolled/ consented
|
24 Participants
|
—
|
|
Enrollment Rate (Critically Ill Infants)
Enrolled/ Consented
|
30 Participants
|
—
|
PRIMARY outcome
Timeframe: approximately 9 monthsPopulation: Critically ill infants who completed the study.
Complete data collection defined as all eligible infant, parent, and clinician data points collected for a given case and was determined at the level of the critically ill infant. Data points for which the participant withdrew prior to relevant data collection were excluded. Intervention and study procedures considered feasible if complete data collection rate is greater than or equal to 80%.
Outcome measures
| Measure |
Critically Ill Infants
n=30 Participants
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
Clinicians
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
|---|---|---|
|
Complete Data Collection (Critically Ill Infants)
Completed data collection
|
29 Participants
|
—
|
|
Complete Data Collection (Critically Ill Infants)
Incomplete data collection
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 4 weeks following use of the toolPopulation: Not applicable to the infant group.
Acceptability will be measured using an acceptability questionnaire, consisting of close-ended items with 5-point likert scale response options (strongly disagree, disagree, neither agree or disagree, agree, strongly agree).
Outcome measures
| Measure |
Critically Ill Infants
n=40 Participants
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
Clinicians
n=30 Participants
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
|---|---|---|
|
Parent and Clinician Acceptability
Found to be helpful (agreed/strongly agreed)
|
30 Participants
|
28 Participants
|
|
Parent and Clinician Acceptability
Found to be helpful (all other response items)
|
10 Participants
|
2 Participants
|
|
Parent and Clinician Acceptability
Would recommend to other parents (agreed/ Strongly agreed)
|
35 Participants
|
29 Participants
|
|
Parent and Clinician Acceptability
Would recommend to other parents (all other response items)
|
5 Participants
|
1 Participants
|
|
Parent and Clinician Acceptability
Would use in the future (agreed/strongly agreed)
|
33 Participants
|
29 Participants
|
|
Parent and Clinician Acceptability
Would use in the future (all other response items)
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, and up to 4 weeks following use of the toolPopulation: Only applicable to the parent group.
PROMIS measures assess the extent to which patients experience challenges with symptoms over the past 7 days. Scores are derived using a standardized T-score metric, with a mean of 50 and a standard deviation of 10. Higher scores reflect greater symptom severity.
Outcome measures
| Measure |
Critically Ill Infants
n=41 Participants
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
Clinicians
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
|---|---|---|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline PROMIS: Ability to Participate in Social Roles and Activities
|
53.8 score on a scale
Interval 44.2 to 64.2
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Post Intervention PROMIS: Ability to Participate in Social Roles and Activities
|
51.8 score on a scale
Interval 44.2 to 64.2
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline PROMIS: Emotional Distress-Anxiety
|
57.7 score on a scale
Interval 51.3 to 64.9
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Post Intervention PROMIS: Emotional Distress-Anxiety
|
57.5 score on a scale
Interval 48.9 to 62.7
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline PROMIS: Emotional Distress - Depression
|
47.8 score on a scale
Interval 38.2 to 55.1
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Post Intervention PROMIS: Emotional Distress - Depression
|
52.5 score on a scale
Interval 42.9 to 55.8
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline PROMIS: Fatigue
|
53.9 score on a scale
Interval 48.6 to 58.9
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Post Intervention: Fatigue
|
53.2 score on a scale
Interval 46.4 to 62.4
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline PROMIS: Pain Interference
|
49.2 score on a scale
Interval 41.6 to 55.7
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Post Intervention PROMIS: Pain Interference
|
41.6 score on a scale
Interval 41.6 to 51.9
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline PROMIS: Physical Function
|
57.0 score on a scale
Interval 47.8 to 57.0
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Post Intervention PROMIS: Physical Function
|
57.0 score on a scale
Interval 47.3 to 57.0
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline PROMIS: Sleep Disturbance
|
50.1 score on a scale
Interval 49.0 to 57.7
|
—
|
|
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Post-Intervention PROMIS: Sleep Disturbance
|
51.4 score on a scale
Interval 47.0 to 56.3
|
—
|
SECONDARY outcome
Timeframe: Up to 4 weeks following use of the toolPopulation: Only applicable to the parent group.
Items can be summed and scored. Score ranges from 0-100, where a higher score indicates higher perceived preparedness for decision making.
Outcome measures
| Measure |
Critically Ill Infants
n=40 Participants
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
Clinicians
Parent(s) of critically ill infants received the decision making guide intervention and could choose to share their completed tool with their infant's clinicians.
|
|---|---|---|
|
Parent Preparation for Decision Making, as Measured by the PrepDM
|
73.75 score on a scale
Interval 59.38 to 90.0
|
—
|
Adverse Events
Critically Ill Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Parent(s) of Critically Ill Infant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place