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Decision Making Support for Parents and Caregivers

Primary Purpose

Neonatal Critical Illness, Pediatric Critical Illness

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Decision Making Guide

About this trial

This is an interventional other trial for Neonatal Critical Illness

Eligibility Criteria

1 Day - 1 Year (Child)All SexesDoes not accept healthy volunteers

Study participants will include English-speaking parents of critically ill infants and children admitted to Duke University Hospital. Infant inclusion criteria will include age < 1 year, admission to a critical care unit, and 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.

Sites / Locations

Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Use of Decision Making Tool

Arm Description

Single Arm design, study team will deliver the tool to be used by the parent(s) to help guide them in discussion with their infant's clinicians.

Outcomes

Primary Outcome Measures

Intervention feasibility, as measured by enrollment rate greater than or equal to 50%

Intervention feasibility, as measured by complete data collection rate greater than or equal to 80%

Secondary Outcome Measures

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 and open-ended response items.

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.

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.

Full Information

NCT ID

NCT05733975

First Posted

January 24, 2023

Last Updated

April 26, 2023

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT05733975

Brief Title

Decision Making Support for Parents and Caregivers

Official Title

Decision Making Support for Parents and Caregivers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 26, 2023 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatal Critical Illness, Pediatric Critical Illness

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Use of Decision Making Tool

Arm Type

Other

Arm Description

Single Arm design, study team will deliver the tool to be used by the parent(s) to help guide them in discussion with their infant's clinicians.

Intervention Type

Other

Intervention Name(s)

Decision Making Guide

Intervention Description

The tool will be used by parent(s) to help guide them in discussion with their infant's clinicians.

Primary Outcome Measure Information:

Title

Intervention feasibility, as measured by enrollment rate greater than or equal to 50%

Time Frame

End of study, approximately 18 months

Title

Intervention feasibility, as measured by complete data collection rate greater than or equal to 80%

Time Frame

End of study, approximately 18 months

Secondary Outcome Measure Information:

Title

Parent and clinician acceptability of the intervention as measured by an acceptability questionnaire

Description

Acceptability will be measured using an acceptability questionnaire, consisting of close-ended and open-ended response items.

Time Frame

Up to 4 weeks following use of the tool

Title

Parent psychological distress, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)

Description

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.

Time Frame

Baseline, and up to 4 weeks following use of the tool

Title

Parent preparation for decision making, as measured by the PrepDM

Description

Items can be summed and scored. A higher score indicates higher perceived preparedness for decision making.

Time Frame

Up to 4 weeks following use of the tool

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kimberley A Fisher, PhD

Phone

919-681-4913

kimberley.fisher@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monica Lemmon, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kimberley A Fisher, PhD

Phone

919-681-4913

kimberley.fisher@duke.edu

First Name & Middle Initial & Last Name & Degree

Monica M Lemmon, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share individual participant level data

Citations:

PubMed Identifier

28193115

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.

Results Reference

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PubMed Identifier

1556799

Citation

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

Results Reference

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PubMed Identifier

15098087

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.

Results Reference

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PubMed Identifier

17353493

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.

Results Reference

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PubMed Identifier

10966293

Citation

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.

Results Reference

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PubMed Identifier

15640361

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.

Results Reference

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PubMed Identifier

22635048

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.

Results Reference

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PubMed Identifier

28402085

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.

Results Reference

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PubMed Identifier

30690645

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.

Results Reference

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PubMed Identifier

18762529

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.

Results Reference

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PubMed Identifier

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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.

Results Reference

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Decision Making Support for Parents and Caregivers

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