Decision Making Support for Parents and Caregivers

NCT05733975 | Completed Results

• 2 other identifiers: Pro00111995K23NS116453
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Critical Illness; Pediatric Critical Illness

Outcome Measures

Primary Outcomes (2)

• Enrollment Rate (Critically Ill Infants)

  Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%.

  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%.

  approximately 9 months

Secondary Outcomes (3)

• Parent and Clinician Acceptability

  Up to 4 weeks following use of the tool

• 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

• Parent Preparation for Decision Making, as Measured by the PrepDM

  Up to 4 weeks following use of the tool

Study Arms (3)

Critically Ill Infants

OTHER

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.

Other: Decision Making Guide

Parent(s) of Critically Ill Infant

OTHER

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.

Other: Decision Making Guide

Clinicians

OTHER

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.

Other: Decision Making Guide

Interventions

Decision Making Guide OTHER

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

Clinicians; Critically Ill Infants; Parent(s) of Critically Ill Infant

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age \< 1 year,
• admission to a critical care unit, and
• an anticipated serious health care decision

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (12)

• 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.

  PMID: 28193115 BACKGROUND

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

  PMID: 1556799 BACKGROUND

• 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.

  PMID: 15098087 BACKGROUND

• 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.

  PMID: 17353493 BACKGROUND

• 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.

  PMID: 10966293 BACKGROUND

• 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.

  PMID: 15640361 BACKGROUND

• 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.

  PMID: 22635048 BACKGROUND

• 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.

  PMID: 28402085 BACKGROUND

• 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.

  PMID: 30690645 BACKGROUND

• 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.

  PMID: 18762529 BACKGROUND

• 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.

  PMID: 12193517 BACKGROUND

• Lemmon ME, Bansal S, Nanduri N, Davalos A, Glass HC, Lord B, Moline K, Pilon B, Sharpe R, Brandon D, Hong H, Samsa G, Cox CE, Pollak KI. Feasibility of an Intervention to Support Shared Decision-Making for Critically Ill Infants. J Pediatr. 2025 Aug;283:114632. doi: 10.1016/j.jpeds.2025.114632. Epub 2025 May 2.

  PMID: 40319938 DERIVED

Results Point of Contact

• Title: Dr. Monica Lemmon
• Organization: Duke Univerisity Medical Center

monica.lemmon@duke.edu

919-668-0477

Study Officials

• Monica Lemmon, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 17, 2023
• Study Start: May 2, 2023
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)