Clinical trial NCT05733975: Decision Making Support for Parents and Caregivers
Official title: Decision Making Support for Parents and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Critical Illness
Pediatric Critical Illness
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-02-17
Enrollment: 104
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Enrollment Rate (Critically Ill Infants)
timeFrame: At enrollment (approximately 9 months)
measure: Complete Data Collection (Critically Ill Infants)
timeFrame: approximately 9 months
Secondary outcomes:
measure: Parent and Clinician Acceptability
timeFrame: Up to 4 weeks following use of the tool
measure: Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, and up to 4 weeks following use of the tool
measure: Parent Preparation for Decision Making, as Measured by the PrepDM
timeFrame: Up to 4 weeks following use of the tool
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Monica Lemmon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cox CE, Lewis CL, Hanson LC, Hough CL, Kahn JM, White DB, Song MK, Tulsky JA, Carson SS. Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation. Crit Care Med. 2012 Aug;40(8):2327-34. doi: 10.1097/CCM.0b013e3182536a63.
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citation: Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, Lewis CL, Hanson LC, Carson SS. Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29.
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citation: Zupancic JA, Kirpalani H, Barrett J, Stewart S, Gafni A, Streiner D, Beecroft ML, Smith P. Characterising doctor-parent communication in counselling for impending preterm delivery. Arch Dis Child Fetal Neonatal Ed. 2002 Sep;87(2):F113-7. doi: 10.1136/fn.87.2.f113.