Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
216 participants
INTERVENTIONAL
2022-06-06
2027-02-28
Brief Summary
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Detailed Description
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Recruitment will be conducted at Indiana University (IU), the University of California at San Francisco (UCSF), the University of Kansas, the University of California at San Diego (UCSD), Northwestern University, The Ohio State University (OSU), and the University of Pennsylvania (UPenn).
This study consists of 3-4 points of data collection, depending on group assignment. Participants will be randomized into a treatment group or control group at the start of the study. All participants will complete the T0 interview, which consists of a set of baseline questionnaires and survey instruments that will be administered in-person, prior to delivery and after they have been counseled on their neonatal treatment options. Immediately following T0, participants who are assigned to the control group will proceed with usual care. Participants who are randomized to the intervention will review the Periviable GOALS DST, which contains outcomes information, values clarification and embedded short documentary style videos. The 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. After viewing the DST, participants will repeat instruments from T0 and provide feedback regarding the tool's acceptability (T1). Another member of the research team will contact all participants to complete follow-up interviews to assess decision quality, neonatal treatment preference and outcome, and mental health. These interviews will be conducted on postpartum day 1 or 2 (T2), at three months postpartum (T3), and at six months postpartum (T4).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Usual Care (control)
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.
No interventions assigned to this group
Periviable GOALS DST Group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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)
* 1 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 Criteria
* 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)
18 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
Indiana University
OTHER
Responsible Party
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Brownsyne Tucker Edmonds
Associate Professor of Obstetrics and Gynecology and Clinical Pediatrics
Principal Investigators
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Brownsyne Tucker Edmonds, MD, MPH, MS
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Miriam Kuppermann, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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The University of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
University of Massachusetts
Worcester, Massachusetts, United States
The Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The University of Texas at Austin
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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