Actively Recruiting
Promoting Shared Decision Making in Periviable Care: A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool
Led by Indiana University · Updated on 2026-05-11
300
Participants Needed
12
Research Sites
26 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
Researchers are evaluating the Periviable GOALS Decision Support Tool (DST) in a randomized controlled trial to assist pregnant patients facing the threat of periviable delivery, which occurs between 22 0/7 and 25 6/7 weeks of gestation. The goal is to improve shared decision making and satisfaction by providing patient-centered information about neonatal outcomes and helping patients clarify their values. This study involves 144 pregnant patients hospitalized for pregnancy complications that may lead to early delivery, and also aims to include important others who support decision-making. Participants will be randomly assigned to either usual care or the intervention group. Those in the usual care group will receive standard counseling from their healthcare teams. Participants in the intervention group will use the Periviable GOALS DST on an iPad, which includes outcomes information, values clarification, and documentary-style videos designed for easy understanding. The tool supplements clinician counseling and helps patients understand choices between comfort care and life-sustaining efforts. Completion of the DST and related questionnaires will be monitored by research staff. Participants will be involved in up to four data collection points: a baseline interview before delivery (T0), a follow-up shortly after reviewing the DST or usual care (T1), and postpartum interviews on days 1 or 2 (T2), at three months (T3), and six months (T4) after delivery. Researchers will assess shared decision making, decision satisfaction, knowledge, decisional conflict, regret, mental health measures, neonatal treatment and outcomes, and tool acceptability. The study includes safety monitoring and spans from initial counseling through six months postpartum.
CONDITIONS
Brief 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 and 25 6/7 weeks gestation
- Presenting to Labor & Delivery at an approved study site with a pregnancy complication threatening periviable delivery
- Must have been counseled on neonatal treatment options by their healthcare team prior to study approach
- 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 randomization to participate
You will not qualify if you...
- Under 18 years of age
- Incarcerated
- Medically unstable (in active labor and dilated 6cm or more)
- Emotionally unstable
- Not counseled by healthcare team on neonatal treatment options
- Not admitted to Labor & Delivery for threatened early delivery reasons
- Experiencing a known fatal fetal anomaly
- Important others not present at time of randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to delivery
Duration - Up to delivery
Participants are randomized to either review the Periviable GOALS Decision Support Tool or receive usual care involving counseling on neonatal treatment options.
1 baseline visit (in-person) prior to delivery, including questionnaires and intervention or usual care
Duration - Up to 6 months postpartum
Participants complete follow-up interviews to assess decision quality, treatment preference, outcomes, and mental health postpartum.
Follow-up interviews on postpartum day 1 or 2, at 3 months, and at 6 months postpartum
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
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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