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Pregnancy PretermNCT05264779

The Periviable GOALS Decision Support Tool

A study testing Periviable GOALS DST in people with Pregnancy Preterm and Premature Birth, run by Indiana University at 12 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Periviable GOALS DST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
12 sitesUnited States
Study dates
6 Jun 2022to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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

Who cannot join

  • 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)

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shelley Hoffman, MPH contact

3172789636

laymans@iu.edu

12 sites in 1 country

United States12 sites, 12 recruiting
  • The University of Texas at Austin

    Austin, Texas, 78712

    Brooke Lasher, 5123247036, brooke.lasher@austin.utexas.edu

    Lorie Harper, MD, MSCI

    Recruiting
  • Northwestern University

    Chicago, Illinois, 60611

    Brittney M Williams, MPH, 3125033476, brittney.williams@northwestern.edu

    Lynn M Yee, MD, MPH

    Recruiting
  • The Ohio State University

    Columbus, Ohio, 43210

    Anna Bartholomew, MPH, RN, 6146853229, mailto:anna.bartholomew@osumc.edu

    William Grobman, MD, MBA

    Recruiting
  • Indiana University

    Indianapolis, Indiana, 46202

    Shelley M Hoffman, MPH, 3172789636, laymans@iu.edu

    Recruiting
  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Raysa Williams, 913-588-5000, swilliams14@kumc.edu

    Megan M Thomas, MD

    Recruiting
  • The University of Kentucky

    Lexington, Kentucky, 40506

    Shawn England, MA, CCRP, 8596089393, shawn.england@uky.edu

    Emily DeFranco, DO, MS

    Recruiting
  • Yale University

    New Haven, Connecticut, 06510

    Lauren Perley, lauren.perley@yale.edu

    Mert Bahtiyar, MD

    Recruiting
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Meaghan McCabe, MPH, 9737472824, meaghan.mccabe@pennmedicine.upenn.edu

    Sindhu K Srinivas, MD, MSCE

    Recruiting
  • Brown University

    Providence, Rhode Island, 02912

    Angelica Demartino, mailto:AMDemartino@CareNE.org

    William Grobman, MD, MBA

    Not yet recruiting
  • The University of California San Diego

    San Diego, California, 92121

    Samantha LaBelle, slabelle@health.ucsd.edu

    Cynthia Gyamfi-Bannerma, MD, MS

    Recruiting
  • University of California San Francisco

    San Francisco, California, 94143

    Kimberly Coleman-Phox, MPH, (415) 476-6406, Kimberly.Coleman-Phox@ucsf.edu

    Recruiting
  • University of Massachusetts

    Worcester, Massachusetts, 01605

    Monalisa Dmello, Monalisa.Dmello@umassmemorial.org

    Katherine M Johnson, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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), the University of Pennsylvania (UPenn), The University of Texas at Austin (UTA), Yale University, University of Massachusetts (UMass), the University of Kentucky (UK), and Brown University.

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).

Being tested
Periviable GOALS DST
Keywords
Decision making, Periviable delivery, Preterm birth, Risk Communication, Neonatal Resuscitation
Medical subject headings
Premature Birth, Pregnancy Complications, Obstetric Labor, Premature, Obstetric Labor Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Periviable GOALS DSTOther

    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.

Study groups in NCT05264779
Study groupRoleWhat they receive
Usual Care (control)No interventionParticipants 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.
Periviable GOALS DST GroupExperimentalParticipants 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.
Receives: Other: Periviable GOALS DST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 day to 2 weeks after delivery

  2. 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.

    Measured: 1 day to 2 weeks after delivery

Secondary outcomes (13)
  1. 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).

    Measured: 1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery

  2. 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.

    Measured: Before delivery

  3. 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.

    Measured: 1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery

  4. 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.

    Measured: 1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery

  5. Depression

    9-item Patient Health Questionnaire (PHQ-9), administered in-person and via phone/Zoom calls at four time points. Participants are asked to indicate how much they have been bothered by a list of problems over the last two weeks. There are 4 response ranging from 0 (not at all) to 4 (nearly every day). Total scores range from 0-27 and are organized into 5 categories: minimal depression (0-4), mild depression (5-9), moderate depression (10-14), moderately severe depression (15-19), and severe depression (20-27).

    Measured: Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

  6. Anxiety

    7-item Generalized Anxiety Disorder (GAD-7), administered in-person and via phone/Zoom calls at four time points. Participants are asked to indicate how much they have been bothered by a list of problems over the last two weeks. There are 4 responses ranging from 0 (not at all) to 4 (nearly every day). Total scores range from 0-21 and are organized into 4 categories: minimal anxiety (0-4), mild anxiety (5-9), moderate anxiety (10-14), and severe anxiety (15-21).

    Measured: Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

  7. Post-Traumatic Stress Disorder

    22-item Impact of Events Scale-Revised (IES-R), administered in-person or via phone/Zoom call. Participants are asked to indicate how much they were distressed or bothered during the past seven days by each difficulty listed, in relation to losing their child to periviable delivery or their delivery experience (if their child survived). There are 5 response categories ranging from 0 (not at all) to 4 (extremely) with total scores ranging from 0-88. Scores of 33 or higher indicates a probable diagnoses for PTSD.

    Measured: Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

  8. Number of Parents who Preferred Resuscitation vs. Palliation

    Medical records will be reviewed for documentation of parental treatment preference (attempt resuscitation vs. palliation), treatment provided, and neonatal outcome (death, neurodevelopmental impairment, gestational age at delivery). The investigators will also assess treatment preferences at the first interview to account for baseline difference. To do so, participants will be asked whether they have been asked to make any treatment decisions regarding their baby, and if so, the types of decisions they were asked to make. If the participant identifies resuscitation versus palliative care as a decision they have been asked to make, they will be asked about their preference regarding these two options. If they make no mention of resuscitation the investigators will ask if the doctors have discussed resuscitation (Y/N), comfort care (Y/N), and then ask if they have decided which treatment option they prefer (Resuscitation, Comfort Care, Undecided).

    Measured: Before delivery and 1-2 days after delivery

  9. Neonatal Treatment Provided

    Medical records will be reviewed for documentation of neonatal treatment provided (resuscitation vs. palliation).

    Measured: Up to 6 months after delivery

  10. Neonatal Outcome

    Medical records will be reviewed for documentation of neonatal outcome (death, neurodevelopmental impairment, gestational age at delivery).

    Measured: Up to 6 months after delivery

  11. Acceptability of the decision support tool

    Decision Aid Acceptability Questionnaire that elicits feedback from viewers of the GOALS DST including acceptability of format, whether the information was presented in a balanced/fair manner, clarity of information, helpfulness of the DST, and whether users would recommend it to other parents. Will be administered in-person, immediately following viewing the Periviable GOALS DST.

    Measured: Before delivery

  12. Preparation for Decision Making

    10-item Preparation for Decision Making Scale (PrepDM) that covers all of the core attributes for assessing the quality of the decision-making process except the extent to which patients feel informed about options and outcomes. Will be administered in-person, immediately following viewing the Periviable GOALS DST.

    There are 5 response categories ranging from 1 (not at all) to 5 (a great deal) with higher scores indicating higher perceived level of preparation for decision making.

    Measured: Before delivery

  13. 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.

    Measured: 3 months and 6 months after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start6 Jun 2022
  3. Primary completionAug 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05264779
Sponsor's protocol ID
R01HS028001
Status last verified
Apr 2026
First submitted
6 Dec 2021
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participant data will only be shared with approved members of the study team.

Questions about this trial

What is this clinical trial studying?

A study testing Periviable GOALS DST in people with Pregnancy Preterm and Premature Birth, run by Indiana University at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shelley Hoffman, MPH (3172789636, laymans@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shared Decision Making (time frame: 1 day to 2 weeks after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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