RecruitingNot ApplicableNCT05264779

The Periviable GOALS Decision Support Tool

Promoting Shared Decision Making in Periviable Care: A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool


Sponsor

Indiana University

Enrollment

300 participants

Start Date

Jun 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0/7 - 25 6/7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a decision-support tool called the Periviable GOALS tool, which helps pregnant people and their families make informed decisions about care for extremely premature babies born around 22-26 weeks of pregnancy. The tool guides conversations about options like resuscitation or comfort care. You may be eligible if: - You are a pregnant adult (18 years or older) - You are between 22 and 26 weeks pregnant - You are admitted to Labor and Delivery with a complication that could lead to very early delivery (e.g., ruptured membranes, preterm labor, preeclampsia, growth restriction) - You have already been counseled by your healthcare team about newborn treatment options You may NOT be eligible if: - You are under 18 years old - You are currently incarcerated - You are medically unstable (in active labor at 6 cm dilation or more) - You are emotionally unstable - You have a known fatal fetal anomaly - You have not yet been counseled about newborn care options Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPeriviable GOALS DST

An iPad application that contains outcomes information, values clarification and embedded short documentary style videos. The tool was designed with low-literacy and low-numeracy populations in mind, and utilizes graphics and video content to enhance meaning-making of complex medical information and jargon. The GOALS DST refers patients back to their physicians to discuss specific treatment options, local outcomes, and management strategies available to them. The DST's content focuses largely on helping patients better understand the choice they have between comfort care and life-sustaining efforts in the context of periviable delivery.


Locations(12)

The University of California San Diego

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Yale University

New Haven, Connecticut, United States

Northwestern University

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

The University of Kentucky

Lexington, Kentucky, United States

University of Massachusetts

Worcester, Massachusetts, United States

The Ohio State University

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Brown University

Providence, Rhode Island, United States

The University of Texas at Austin

Austin, Texas, United States

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NCT05264779


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