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.
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.
Under 18 years of age
Incarcerated
Medically unstable (i.e. in active labor and dilated 6cm or more)
Emotionally unstable
Parallel
Periviable GOALS DST
Other interventionAn 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.
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.
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.
Decisional Conflict
16-item Decisional Conflict Scale (DCS) administered during Zoom interview. There are 5 response categories, ranging from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Knowledge about Periviable Delivery
21-item knowledge scale, administered in-person prior to delivery. Scores range from 0-21 with higher scores indicating greater knowledge.
Decision Regret
5-item Decision Regret Scale, administered in person or via phone/Zoom call at three time points. There are 5 response categories ranging from 1 (strongly agree) to 5 (strongly disagree) with higher scores correlating to higher decision regret.
Decision Control
5-item subscale from the Decision Evaluation Scale, administered in-person or via phone/Zoom call at three time points. There are five responses ranging from 1 (strongly disagree) to 5 (strongly agree) with higher scores correlating to lower decision control.
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Indiana University
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator
