The Periviable GOALS Decision Support Tool

Description

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.

Conditions

Pregnancy Preterm, Premature Birth, Pregnancy Complications, Obstetric Labor, Premature, Obstetric Labor Complications

Study Overview

Study Details

Study overview

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.

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

The Periviable GOALS Decision Support Tool

Condition
Pregnancy Preterm
Intervention / Treatment

-

Contacts and Locations

San Diego

The University of California San Diego, San Diego, California, United States, 92121

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Kansas City

The University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Austin

The University of Texas at Austin, Austin, Texas, United States, 78712

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Under 18 years of age
  • * Incarcerated
  • * Medically unstable (i.e. in active labor and dilated 6cm or more)
  • * Emotionally unstable
  • * Have not been counseled by their healthcare team regarding neonatal treatment options
  • * Are not admitted to Labor \& Delivery for reasons indicative of a threatened early delivery
  • * If they are experiencing a known fatal fetal anomaly
  • * Are not present at the time of randomization (only for important others)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Brownsyne Tucker Edmonds, MD, MPH, MS, PRINCIPAL_INVESTIGATOR, Indiana University School of Medicine

Miriam Kuppermann, PhD, MPH, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2026-02