Decision Making Support for Parents and Caregivers

Not Applicable

Completed

• Conditions: Neonatal Critical Illness; Pediatric Critical Illness
• Interventions: Other: Decision Making Guide

• Registration Number: NCT05733975
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Study Start: 2023-05-02
• Primary Completion: 2024-01-29
• Study Completion: 2024-01-29
• Results First Submitted: 2025-01-09
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Results First Posted: 2025-03-18
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of Decision Making Tool	Decision Making Guide	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States