Decision Making Support for Parents and Caregivers

Duke University

Status: Completed

Conditions: Neonatal Critical Illness; Pediatric Critical Illness

Treatments: Other: Decision Making Guide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05733975

Pro00111995

K23NS116453 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 1 day to 1 year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 3 patient groups

Critically Ill Infants

Other group

Description:

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.

Treatment:

Other: Decision Making Guide

Parent(s) of Critically Ill Infant

Other group

Description:

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.

Treatment:

Other: Decision Making Guide

Clinicians

Other group

Description:

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.

Treatment:

Other: Decision Making Guide