Decision Making Support for Parents and Caregivers

Study Overview
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Brief Summary
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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
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The intervention includes a paper-based decision guide. This decision guide includes content related to decisional awareness, values clarification, and a series of question prompts that are directed toward guiding parents through health care decision making.

Official Title
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Decision Making Support for Parents and Caregivers

Conditions
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Neonatal Critical Illness, Pediatric Critical Illness

Intervention / Treatment
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* Other: Decision Making Guide


Participation Criteria
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Eligibility Criteria
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Study participants will include English-speaking parents of critically ill infants and children admitted to Duke University Hospital. Infant inclusion criteria will include age < 1 year, admission to a critical care unit, and 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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Use of Decision Making Tool<br>Single Arm design, study team will deliver the tool to be used by the parent(s) to help guide them in discussion with their infant's clinicians. | Other: Decision Making Guide<br>* The tool will be used by parent(s) to help guide them in discussion with their infant's clinicians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention feasibility, as measured by enrollment rate greater than or equal to 50% |  | End of study, approximately 18 months | 
| Intervention feasibility, as measured by complete data collection rate greater than or equal to 80% |  | End of study, approximately 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent and clinician acceptability of the intervention as measured by an acceptability questionnaire | Acceptability will be measured using an acceptability questionnaire, consisting of close-ended items. | Up to 4 weeks following use of the tool | 
| Parent psychological distress, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | PROMIS assesses the extent to which patients experience challenges with symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater symptom severity. | Baseline, and up to 4 weeks following use of the tool | 
| Parent preparation for decision making, as measured by the PrepDM | Items can be summed and scored. A higher score indicates higher perceived preparedness for decision making. | Up to 4 weeks following use of the tool |