Actively Recruiting
The Periviable GOALS Decision Support Tool
Led by Indiana University · Updated on 2026-05-11
300
Participants Needed
12
Research Sites
243 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
A
Agency for Healthcare Research and Quality (AHRQ)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Periviable GOALS Decision Support Tool
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Pregnant between 22 0/7 to 25 6/7 weeks gestation
- Hospitalized at an approved study site with a pregnancy complication threatening periviable delivery
- Have been counseled on neonatal treatment options by their healthcare team
- Important others must be adults 18 years or older
- Important others must be identified by the pregnant person as involved in decision making
- Important others must be present at the time of randomization
You will not qualify if you...
- Under 18 years of age
- Incarcerated
- Medically unstable (actively in labor and dilated 6cm or more)
- Emotionally unstable
- Not counseled on neonatal treatment options by healthcare team
- Not admitted to Labor & Delivery for threatened early delivery
- Experiencing a known fatal fetal anomaly
- Important others not present at the time of randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
The University of California San Diego
San Diego, California, United States, 92121
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
7
The University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
8
University of Massachusetts
Worcester, Massachusetts, United States, 01605
Actively Recruiting
9
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
10
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
11
Brown University
Providence, Rhode Island, United States, 02912
Not Yet Recruiting
12
The University of Texas at Austin
Austin, Texas, United States, 78712
Actively Recruiting
Research Team
S
Shelley Hoffman, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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