The Periviable GOALS Decision Support Tool
Promoting Shared Decision Making in Periviable Care: A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool
Indiana University
216 participants
Jun 6, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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
Exclusion Criteria8
- 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)
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Interventions
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.
Locations(10)
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NCT05264779