Decision Making Support for Parents and Caregivers

Pediatric Critical Illness Clinical Trial

Official title:

Decision Making Support for Parents and Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05733975
• Other study ID #: Pro00111995
• Secondary ID: K23NS116453
• Status: Completed
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: January 29, 2024

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The intervention includes a paper-based decision guide. This decision guide includes content related to decisional awareness, values clarification, and a series of question prompts that are directed toward guiding parents through health care decision making.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 29, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Pediatric Critical Illness

Intervention

Other:
• Decision Making Guide
The tool will be used by parent(s) to help guide them in discussion with their infant's clinicians.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (11)

Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061. — View Citation

Boss RD, Hutton N, Sulpar LJ, West AM, Donohue PK. Values parents apply to decision-making regarding delivery room resuscitation for high-risk newborns. Pediatrics. 2008 Sep;122(3):583-9. doi: 10.1542/peds.2007-1972. — View Citation

Carlet J, Thijs LG, Antonelli M, Cassell J, Cox P, Hill N, Hinds C, Pimentel JM, Reinhart K, Thompson BT. Challenges in end-of-life care in the ICU. Statement of the 5th International Consensus Conference in Critical Care: Brussels, Belgium, April 2003. Intensive Care Med. 2004 May;30(5):770-84. doi: 10.1007/s00134-004-2241-5. Epub 2004 Apr 20. — View 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. — View 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. — View Citation

Curtis JR, Engelberg RA, Wenrich MD, Shannon SE, Treece PD, Rubenfeld GD. Missed opportunities during family conferences about end-of-life care in the intensive care unit. Am J Respir Crit Care Med. 2005 Apr 15;171(8):844-9. doi: 10.1164/rccm.200409-1267OC. Epub 2005 Jan 7. — View Citation

Emanuel EJ, Emanuel LL. Four models of the physician-patient relationship. JAMA. 1992 Apr 22-29;267(16):2221-6. No abstract available. — View Citation

Lemmon ME, Boss RD, Bonifacio SL, Foster-Barber A, Barkovich AJ, Glass HC. Characterization of Death in Neonatal Encephalopathy in the Hypothermia Era. J Child Neurol. 2017 Mar;32(4):360-365. doi: 10.1177/0883073816681904. Epub 2016 Dec 20. — View Citation

Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5. — View Citation

White DB, Braddock CH 3rd, Bereknyei S, Curtis JR. Toward shared decision making at the end of life in intensive care units: opportunities for improvement. Arch Intern Med. 2007 Mar 12;167(5):461-7. doi: 10.1001/archinte.167.5.461. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention feasibility, as measured by enrollment rate greater than or equal to 50%		End of study, approximately 18 months
Primary	Intervention feasibility, as measured by complete data collection rate greater than or equal to 80%		End of study, approximately 18 months
Secondary	Parent and clinician acceptability of the intervention as measured by an acceptability questionnaire	Acceptability will be measured using an acceptability questionnaire, consisting of close-ended items.	Up to 4 weeks following use of the tool
Secondary	Parent psychological distress, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)	PROMIS assesses the extent to which patients experience challenges with symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater symptom severity.	Baseline, and up to 4 weeks following use of the tool
Secondary	Parent preparation for decision making, as measured by the PrepDM	Items can be summed and scored. A higher score indicates higher perceived preparedness for decision making.	Up to 4 weeks following use of the tool