RECRUITING

The Periviable GOALS Decision Support Tool

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-06-06
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05264779

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Under 18 years of age
  2. * Incarcerated
  3. * Medically unstable (i.e. in active labor and dilated 6cm or more)
  4. * Emotionally unstable
  5. * Have not been counseled by their healthcare team regarding neonatal treatment options
  6. * Are not admitted to Labor \& Delivery for reasons indicative of a threatened early delivery
  7. * If they are experiencing a known fatal fetal anomaly
  8. * Are not present at the time of randomization (only for important others)

Contacts and Locations

Study Contact

Shelley Hoffman, MPH
CONTACT
3172789636
laymans@iu.edu

Principal Investigator

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 Locations (Sites)

The University of California San Diego
San Diego, California, 92121
United States
University of California San Francisco
San Francisco, California, 94143
United States
Northwestern University
Chicago, Illinois, 60611
United States
Indiana University
Indianapolis, Indiana, 46202
United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
The Ohio State University
Columbus, Ohio, 43210
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
The University of Texas at Austin
Austin, Texas, 78712
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-06
Study Completion Date2026-02

Study Record Updates

Study Start Date2022-06-06
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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