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OpenTrials
Completed

NCT Number: NCT05733975

Decision Making Support for Parents and Caregivers

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.

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Key information

Conditions

Neonatal Critical Illness Pediatric Critical Illness

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Decision Making Guide

Other

The tool includes a brief introduction to the tool and decision-making, a values clarification exercise, and a question prompt list.

Primary outcomes

  1. Enrollment Rate (Critically Ill Infants)

    Time frame: At enrollment (approximately 9 months)

    Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%.

  2. Complete Data Collection (Critically Ill Infants)

    Time frame: 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 outcomes

  1. Parent and Clinician Acceptability

    Time frame: 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).

  2. Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 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.

  3. Parent Preparation for Decision Making, as Measured by the PrepDM

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 17, 2023
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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