Neonatal Critical Illness, Pediatric Critical Illness
Conditions
Brief summary
The purpose of this study is to test the feasibility and acceptability of a tool to support decision making for parents of critically ill infants.
Detailed description
In this single-arm mixed methods prospective feasibility study, we will enroll infants, parents, and clinicians. The intervention is a paper-based decision guide that contains a values clarification exercise and question prompt list.
Interventions
OTHERDecision Making Guide
The tool includes a brief introduction to the tool and decision-making, a values clarification exercise, and a question prompt list.
Sponsors
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Years
Healthy volunteers
No
Inclusion criteria
Study participants will include English-speaking parents of critically ill infants and children admitted to Duke University Hospital. Infant inclusion criteria will include 1. age \< 1 year, 2. admission to a critical care unit, and 3. an anticipated serious health care decision All parents of eligible infants will be considered for inclusion. Parent
Exclusion criteria
will include 1) age \< 18 years, 2) hearing or speech impairment, and 3) non-English speakers. All clinicians of eligible infants will be considered for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate (Critically Ill Infants) | At enrollment (approximately 9 months) | Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%. |
| Complete Data Collection (Critically Ill Infants) | approximately 9 months | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent and Clinician Acceptability | Up to 4 weeks following use of the tool | 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). |
| Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline, and up to 4 weeks following use of the tool | 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. |
| Parent Preparation for Decision Making, as Measured by the PrepDM | Up to 4 weeks following use of the tool | Items can be summed and scored. Score ranges from 0-100, where a higher score indicates higher perceived preparedness for decision making. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 43 |
| 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. | 30 |
| Total | 103 |
Baseline characteristics
| Characteristic | Critically Ill Infants | Total | Parent(s) of Critically Ill Infant | Clinicians |
|---|---|---|---|---|
| Age, Continuous Age at enrollment | 20 days | 20 days | — | — |
| Age, Continuous | — | 34.0 years | 30.0 years | 41.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 93 Participants | 39 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 33 Participants | 15 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 57 Participants | 19 Participants | 25 Participants |
| Sex: Female, Male Female | 10 Participants | 62 Participants | 30 Participants | 22 Participants |
| Sex: Female, Male Male | 20 Participants | 41 Participants | 13 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 30 | 0 / 44 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 44 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 44 | 0 / 30 |
Outcome results
Primary
Complete Data Collection (Critically Ill Infants)
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%.
Time frame: approximately 9 months
Population: Critically ill infants who completed the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Critically Ill Infants | Complete Data Collection (Critically Ill Infants) | Completed data collection | 29 Participants |
| Critically Ill Infants | Complete Data Collection (Critically Ill Infants) | Incomplete data collection | 1 Participants |
Primary
Enrollment Rate (Critically Ill Infants)
Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%.
Time frame: At enrollment (approximately 9 months)
Population: Eligible critically ill infants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Critically Ill Infants | Enrollment Rate (Critically Ill Infants) | Not enrolled/ consented | 24 Participants |
| Critically Ill Infants | Enrollment Rate (Critically Ill Infants) | Enrolled/ Consented | 30 Participants |
Secondary
Parent and Clinician Acceptability
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).
Time frame: Up to 4 weeks following use of the tool
Population: Not applicable to the infant group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Critically Ill Infants | Parent and Clinician Acceptability | Found to be helpful (all other response items) | 10 Participants |
| Critically Ill Infants | Parent and Clinician Acceptability | Would recommend to other parents (all other response items) | 5 Participants |
| Critically Ill Infants | Parent and Clinician Acceptability | Found to be helpful (agreed/strongly agreed) | 30 Participants |
| Critically Ill Infants | Parent and Clinician Acceptability | Would use in the future (agreed/strongly agreed) | 33 Participants |
| Critically Ill Infants | Parent and Clinician Acceptability | Would recommend to other parents (agreed/ Strongly agreed) | 35 Participants |
| Critically Ill Infants | Parent and Clinician Acceptability | Would use in the future (all other response items) | 7 Participants |
| Clinicians | Parent and Clinician Acceptability | Would use in the future (all other response items) | 1 Participants |
| Clinicians | Parent and Clinician Acceptability | Found to be helpful (agreed/strongly agreed) | 28 Participants |
| Clinicians | Parent and Clinician Acceptability | Found to be helpful (all other response items) | 2 Participants |
| Clinicians | Parent and Clinician Acceptability | Would recommend to other parents (agreed/ Strongly agreed) | 29 Participants |
| Clinicians | Parent and Clinician Acceptability | Would recommend to other parents (all other response items) | 1 Participants |
| Clinicians | Parent and Clinician Acceptability | Would use in the future (agreed/strongly agreed) | 29 Participants |
Secondary
Parent Preparation for Decision Making, as Measured by the PrepDM
Items can be summed and scored. Score ranges from 0-100, where a higher score indicates higher perceived preparedness for decision making.
Time frame: Up to 4 weeks following use of the tool
Population: Only applicable to the parent group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Critically Ill Infants | Parent Preparation for Decision Making, as Measured by the PrepDM | 73.75 score on a scale |
Secondary
Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
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.
Time frame: Baseline, and up to 4 weeks following use of the tool
Population: Only applicable to the parent group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Critically Ill Infants | 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 |
| Critically Ill Infants | 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 |
| Critically Ill Infants | 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 |
| Critically Ill Infants | 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 |
| Critically Ill Infants | 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 |
| Critically Ill Infants | 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 |
| Critically Ill Infants | Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline PROMIS: Fatigue | 53.9 score on a scale |
| Critically Ill Infants | Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | Post Intervention: Fatigue | 53.2 score on a scale |
| Critically Ill Infants | Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline PROMIS: Pain Interference | 49.2 score on a scale |
| Critically Ill Infants | 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 |
| Critically Ill Infants | Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline PROMIS: Physical Function | 57.0 score on a scale |
| Critically Ill Infants | 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 |
| Critically Ill Infants | Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline PROMIS: Sleep Disturbance | 50.1 score on a scale |
| Critically Ill Infants | 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 |