Clinical trial NCT05264779: The Periviable GOALS Decision Support Tool
Official title: Promoting Shared Decision Making in Periviable Care: A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Preterm
Premature Birth
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Keywords: Decision making
Periviable delivery
Preterm birth
Risk Communication
Neonatal Resuscitation
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-03-03
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The investigators will evaluate the Periviable GOALS DST in a randomized controlled trial among 144 pregnant patients between 22 0/7 and 25 6/7 weeks gestation who are hospitalized for a pregnancy complication that threatens periviable delivery. Pregnant patients agreeing to participate will be asked to identify whom they will primarily rely on for assistance in making decisions regarding their delivery plan (e.g., father of the baby, partner, a family member, or any other important individual in the patient's life), referred to as the 'important other' (IO). In terms of IO recruitment goals, the investigators anticipate recruiting 72 IOs. This goal is based on our previous work with a similar population of pregnant patients, in which about half identified an 'important other' to be included in the study.

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).

Eligibility criteria: Inclusion Criteria for Pregnant Persons:

* 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.

Inclusion Criteria for Important Others:

* 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:

* 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)

Primary outcomes:
measure: Shared Decision Making
timeFrame: 1 day to 2 weeks after delivery
measure: Decision Satisfaction
timeFrame: 1 day to 2 weeks after delivery
Secondary outcomes:
measure: Decisional Conflict
timeFrame: 1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery
measure: Knowledge about Periviable Delivery
timeFrame: Before delivery
measure: Decision Regret
timeFrame: 1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery
measure: Decision Control
timeFrame: 1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery
measure: Depression
timeFrame: Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.
measure: Anxiety
timeFrame: Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.
measure: Post-Traumatic Stress Disorder
timeFrame: Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.
measure: Number of Parents who Preferred Resuscitation vs. Palliation
timeFrame: Before delivery and 1-2 days after delivery
measure: Neonatal Treatment Provided
timeFrame: Up to 6 months after delivery
measure: Neonatal Outcome
timeFrame: Up to 6 months after delivery
measure: Acceptability of the decision support tool
timeFrame: Before delivery
measure: Preparation for Decision Making
timeFrame: Before delivery
measure: Decision Satisfaction
timeFrame: 3 months and 6 months after delivery
Other outcomes:
Locations:
city: San Diego
country: United States
facility: The University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: Indiana University School of Medicine
name: Brownsyne Tucker Edmonds, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Miriam Kuppermann, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: