Periviable GOALS DST for Premature Birth

Recruiting at 10 trial locations

Overseen By Shelley Hoffman, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Under 18, Incarcerated, Medically unstable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool designed to help parents make informed decisions about their baby's care if born extremely early, between 22 to almost 26 weeks gestation. The tool, called the Periviable GOALS DST (Decision Support Tool), provides information and helps families clarify their values when facing neonatal resuscitation decisions. Researchers aim to determine if using this tool improves decision-making and increases satisfaction with those decisions. Pregnant individuals between these gestational weeks who have been counseled by their healthcare team about neonatal treatment options are a good fit for this trial. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance decision-making support for families facing critical neonatal care choices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Periviable GOALS DST is safe for use in decision-making?

Research shows that the Periviable GOALS Decision Support Tool (DST) helps families make informed choices about newborn care in very early births. This tool is neither a medication nor a device, so it lacks the associated safety concerns. Instead, it provides information and aids families in understanding what is important to them regarding newborn outcomes.

Studies evaluating tools like this often assess how well people understand the information and their satisfaction with decisions after using the tool. Since the Periviable GOALS DST aims to educate, it is considered safe to use. No reports indicate negative effects from using decision support tools like this one. Users typically find these tools helpful and easy to understand, suggesting they are well-received in practice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Periviable GOALS DST because it offers a new approach to decision-making in the context of premature birth. Unlike standard care, which involves counseling by medical professionals, this tool actively engages participants in understanding their options through a detailed decision support tool (DST). The DST includes educational components and helps clarify values, aiming to empower patients to make informed decisions about their care. By potentially reducing decisional conflict and improving patient knowledge, this tool could enhance the overall decision-making process for families facing the challenges of premature birth.

What evidence suggests that the Periviable GOALS DST is effective for improving shared decision making and decision satisfaction?

Research has shown that the Periviable GOALS Decision Support Tool (DST), which participants in this trial may receive, helps families make better decisions when facing the possibility of an extremely premature birth. Early findings suggest that providing parents with clear information and sharing family stories aids in understanding possible outcomes and making informed choices. This tool helps parents identify what is most important to them regarding their baby's care. Studies indicate that using the DST leads to greater satisfaction with decisions made during this challenging time. It aims to provide families with the knowledge and confidence needed to make tough choices about their baby's care. ^{1 2 3 4 5}

Who Is on the Research Team?

Miriam Kuppermann, PhD, MPH

Principal Investigator

University of California, San Francisco

Brownsyne Tucker Edmonds, MD, MPH, MS

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are pregnant between 22 and almost 25 weeks, facing complications that could lead to very early delivery. They should have already discussed neonatal treatment options with their healthcare team and be able to make decisions for the baby.

Inclusion Criteria

I am between 22 and 24 weeks pregnant.

You must be available and willing to participate at the time of selection.

I am pregnant with complications that might lead to an early delivery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete the T0 interview, consisting of baseline questionnaires and survey instruments administered in-person, prior to delivery and after counseling on neonatal treatment options.

1 day

1 visit (in-person)

Intervention

Participants randomized to the intervention group review the Periviable GOALS DST, complete education and values clarification components, and provide feedback on the tool's acceptability.

1 day

1 visit (in-person)

Follow-up

Participants are contacted for follow-up interviews to assess decision quality, neonatal treatment preference and outcome, and mental health on postpartum day 1 or 2, at three months postpartum, and at six months postpartum.

6 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Periviable GOALS DST

Trial Overview The trial tests a decision support tool called Periviable GOALS DST designed to help parents make informed choices about neonatal resuscitation in extremely premature births. It aims to improve shared decision-making and satisfaction with the decisions made.

How Is the Trial Designed?

Group I: Periviable GOALS DST Group Experimental Treatment 1 Intervention

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.

Group II: Usual Care (control) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

Over the past decade, focusing on outcome measurement and quality improvement in neonatal intensive care units has significantly enhanced the health outcomes for premature infants, more so than new therapies or research methods.

The systematic collection and review of outcome data, along with continuous quality improvement strategies, have proven effective in identifying and resolving issues, suggesting that ongoing quality improvement initiatives will likely lead to even better outcomes for neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Has Quality Improvement Really Improved Outcomes for Babies in the Neonatal Intensive Care Unit? Spitzer, AR.[2019]

The article introduces a new advanced practice role in outcomes management specifically for the perinatal population, emphasizing the importance of coordinated care among diverse healthcare teams.

Over a 3-year period, the implementation of this outcomes management approach led to significant improvements in clinical, functional, service quality, and financial outcomes, highlighting its effectiveness in enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new advanced practice role focused on outcomes management in women's and children's health. Terhaar, M., O'Keefe, S.[2019]

In a study of 99 cases of preterm premature rupture of membranes (pPROM), changing the treatment protocol to include oligohydramnios and elevated elastase levels led to significantly lower incidences of pathological chorioamnionitis and funisitis compared to the previous protocol.

The new protocol also resulted in lower neonatal serum IgM concentrations, suggesting a reduction in the severity of fetal infection, which may improve perinatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective cohort study: a comparison of two different management strategies in patients with preterm premature rupture of membranes. Shinjo, A., Otsuki, K., Sawada, M., et al.[2012]

The Physician Parent Decision Support System (PPADS) is designed to enhance family-centered care in the NICU by providing clinical updates and outcome predictions, which may lead to earlier interventions and better resource allocation.

A usability study with 8 parents and 5 neonatologists indicated that both groups found the PPADS tool easy to use and beneficial for improving communication, suggesting its potential effectiveness in supporting decision-making for infant care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PPADS: Physician-PArent Decision-Support for Neonatal Intensive Care. Frize, M., Bariciak, E., Gilchrist, J.[2022]

The development of a core outcome set for Twin-Twin Transfusion Syndrome (TTTS) aims to standardize the evaluation of treatment outcomes, which is crucial for improving research quality and clinical practice, especially given the varied outcomes reported in existing studies.

An international steering group, including healthcare professionals, researchers, and patients, will use a modified Delphi method to reach consensus on important outcomes, ensuring that the perspectives of all stakeholders are considered in future clinical trials and guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twin-Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set. Khalil, A., Perry, H., Duffy, J., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05264779?term=William+Oh

The Periviable GOALS Decision Support Tool The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05264779

Periviable GOALS Decision Support Tool - UCSF Clinical Trials This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6686668/

Creation of a decision support tool for expectant parents ... Our results suggest that a DST that combines unbiased information and understandable outcomes with family testimonials would be meaningful for periviable SDM.

4. trialx.com trialx.com/clinical-trials/listings/235156/the-periviable-goals-decision-support-tool/?&geo_lat=41.2175&geo_lng=-73.0549&radius=10&place=Milford&user_country=United%20States

The Periviable GOALS Decision Support Tool The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal ...

5. umass.trialstoday.org umass.trialstoday.org/trial/NCT05264779

The Periviable GOALS Decision Support Tool The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal ...