The Periviable GOALS Decision Support Tool

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.

Conditions

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

Interventions

OTHER

Periviable 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.

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ)

  collaborator FED

• Indiana University

  lead OTHER

Principal Investigators

• Brownsyne Tucker Edmonds, MD, MPH, MS · Indiana University

• Miriam Kuppermann, PhD, MPH · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-06

Primary Completion

2026-08-31

Completion

2027-02-28

Countries

• United States

Study Locations