The Periviable GOALS Decision Support Tool

NCT05264779 | Recruiting

• 1 other identifier: R01HS028001
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

Decision making; Periviable delivery; Preterm birth; Risk Communication; Neonatal Resuscitation

Outcome Measures

Primary Outcomes (2)

• Shared Decision Making

  9-item Shared Decision Making Questionnaire (SDM-Q-9) administered in-person or via phone/Zoom call. Scores range from 0 to 100, with a higher score correlating to higher shared decision making.

  1 day to 2 weeks after delivery

• Decision Satisfaction

  6-item Satisfaction with Decision Scale, administered in-person or via phone/Zoom call at three time points. There are 5 response categories ranging from 1 (strongly disagree) to 5 (strongly agree) with higher scores correlating to higher decision satisfaction.

  1 day to 2 weeks after delivery

Secondary Outcomes (13)

• Decisional Conflict

  1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery

• Knowledge about Periviable Delivery

  Before delivery

• Decision Regret

  1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery

• Decision Control

  1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery

• Depression

  Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

Study Arms (2)

Usual Care (control)

NO INTERVENTION

Participants assigned to this group will proceed with usual medical care and treatment, consisting of counseling by the teams of obstetricians and/or neonatologists at the respective study sites.

Periviable GOALS DST Group

EXPERIMENTAL

Participants randomized to the intervention will be presented with the Periviable GOALS DST and instructed to review the DST in its entirety. The participant will complete the education and values clarification components of the DST with the Recruitment RA present to confirm completion. Following completion of the GOALS DST, the Recruitment RA will repeat knowledge and decisional conflict instruments and assess acceptability.

Other: Periviable GOALS DST

Interventions

Periviable GOALS DST OTHER

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.

Periviable GOALS DST Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years or older)
• Pregnant between 22 0/7 to 25 6/7 weeks gestation (this window may be slightly different for each recruitment site, as the gestational window that defines periviable delivery varies by institution).
• Presenting to Labor \& Delivery at an approved study site with a pregnancy complication that poses the potential threat of or need for periviable delivery (e.g., rupture of membranes, preterm labor, shortened cervix, pre-eclampsia, and growth restriction).
• Must have been counseled on their neonatal treatment options (e.g. resuscitation, comfort care) by their healthcare team prior to being approached by the study team.
• Adults (18 years or older)
• per pregnant person
• Is identified by the pregnant person as someone who will be involved in making decisions for the baby
• Must be present at the time of randomization to participate

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (10)

The University of California San Diego

San Diego, California, 92121, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Massachusetts

Worcester, Massachusetts, 01605, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

The University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Brownsyne Tucker Edmonds, MD, MPH, MS

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Miriam Kuppermann, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelley Hoffman, MPH

CONTACT

3172789636; laymans@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assessors of the primary outcome will be blinded to the participant's treatment group. The investigators will utilize a two-research assistant (RA) recruitment approach, wherein one RA collects the T0/T1 information and randomizes the patient to a study arm; and a second RA collects the T2-T4 data, remaining a blinded assessor of the primary outcomes of interest. Further, all other research personnel, including the data manager, statistician, and study investigators will be blinded to the participant's treatment group to minimize the potential for bias in the analysis.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology and Clinical Pediatrics

Model Details: Randomization tables will be generated with SAS v9.4 and will be stratified by recruitment site. The randomization tables will be uploaded into REDCap's randomization module by the data manager. RAs will not be allowed access to these randomization tables to ensure that the data collection remains unbiased.

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: March 3, 2022
• Study Start: June 6, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)