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

Trial Summary

What is the purpose of this trial?

This trial tests a tool called Periviable GOALS DST, which helps parents of extremely premature babies make informed decisions by providing clear information and helping them clarify their values. It targets pregnant patients at risk of delivering very early.

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 data supports the effectiveness of the treatment Periviable GOALS DST for Premature Birth?

The research on quality improvement in neonatal intensive care units shows that focusing on outcome measurement and continuous quality improvement can significantly improve outcomes for premature babies. Additionally, decision-support tools like PPADS, which aid in family-centered care and decision-making, have been found useful and may lead to better resource allocation and reduced negative outcomes. ^{1 2 3 4 5}

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Twin-Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

A new advanced practice role focused on outcomes management in women's and children's health. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Retrospective cohort study: a comparison of two different management strategies in patients with preterm premature rupture of membranes. [2012]

5. Netherlands pubmed.ncbi.nlm.nih.gov

PPADS: Physician-PArent Decision-Support for Neonatal Intensive Care. [2022]