Decision Making Support for Parents and Caregivers

Duke University104 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

104

Conditions

Neonatal Critical Illness Pediatric Critical Illness

Interventions

Decision Making GuideOTHER

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 1 Year

Medical Language ↔ Plain English

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.

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

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