Decision Making Support for Parents and Caregivers

February 1, 2024 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Use of Decision Making Tool
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.
Other: Decision Making Guide
The tool will be used by parent(s) to help guide them in discussion with their infant's clinicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intervention feasibility, as measured by enrollment rate greater than or equal to 50%
Time Frame: End of study, approximately 18 months
End of study, approximately 18 months
Intervention feasibility, as measured by complete data collection rate greater than or equal to 80%
Time Frame: End of study, approximately 18 months
End of study, approximately 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent psychological distress, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame: Baseline, and up to 4 weeks following use of the tool
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
Parent preparation for decision making, as measured by the PrepDM
Time Frame: Up to 4 weeks following use of the tool
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
Parent and clinician acceptability of the intervention as measured by an acceptability questionnaire
Time Frame: Up to 4 weeks following use of the tool
Acceptability will be measured using an acceptability questionnaire, consisting of close-ended items.
Up to 4 weeks following use of the tool

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

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

Investigators

  • Principal Investigator: Monica Lemmon, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Actual)

January 29, 2024

Study Completion (Actual)

January 29, 2024

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00111995
  • K23NS116453 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant level data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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