Study Results
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View full resultsBasic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2023-05-02
2024-01-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Critically Ill Infants
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.
Decision Making Guide
The tool includes a brief introduction to the tool and decision-making, a values clarification exercise, and a question prompt list.
Parent(s) of Critically Ill Infant
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.
Decision Making Guide
The tool includes a brief introduction to the tool and decision-making, a values clarification exercise, and a question prompt list.
Clinicians
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.
Decision Making Guide
The tool includes a brief introduction to the tool and decision-making, a values clarification exercise, and a question prompt list.
Interventions
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Decision Making Guide
The tool includes a brief introduction to the tool and decision-making, a values clarification exercise, and a question prompt list.
Eligibility Criteria
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Inclusion Criteria
2. admission to a critical care unit, and
3. an anticipated serious health care decision
Exclusion Criteria
1 Day
1 Year
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Monica Lemmon, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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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.
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.
Emanuel EJ, Emanuel LL. Four models of the physician-patient relationship. JAMA. 1992 Apr 22-29;267(16):2221-6. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00111995
Identifier Type: -
Identifier Source: org_study_id
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