Family Counseling Education for Preterm Birth

Recruiting at 2 trial locations

Overseen By Christy L Cummings, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Non-English proficient, Fetal malformation, others

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

Compensation: Varies

Number of Visits: Unknown

460 Participants Needed

Trial Summary

What is the purpose of this trial?

Antenatal family counseling for anticipated extremely preterm deliveries remains ethically and practically challenging for maternal-fetal medicine specialists and neonatologists alike. The overall goal of this project is to improve antenatal counseling and counseling outcomes for families facing anticipated extremely preterm delivery through innovative, interdisciplinary simulation-based education for maternal fetal medicine specialists and neonatologists, using language preferred by families, and focusing on eliciting values and building partnerships through advanced communication and relational skills.

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 this treatment?

Simulation-based education and interdisciplinary counseling training have been shown to improve knowledge and communication skills in healthcare providers, as seen in a study where midwives in Kenya and Uganda improved their understanding and practices related to preterm birth. This suggests that similar educational interventions could be effective in enhancing family counseling for preterm birth. ^{1 2 3 4 5}

Is family counseling education for preterm birth safe for humans?

Simulation-based education, which is a part of family counseling education, has been used safely in various healthcare settings to improve knowledge and skills without any reported safety concerns. It provides a safe learning environment for healthcare providers and families, enhancing their ability to care for preterm infants. ^{2 3 6 7 8}

How is the educational intervention treatment for preterm birth different from other treatments?

The educational intervention for preterm birth is unique because it uses simulation-based education to train clinicians and families in communication and decision-making skills, focusing on real-life scenarios and interdisciplinary collaboration, which is not typically a part of standard medical treatments. ^{1 8 9 10 11}

Research Team

Christy Cummings, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

This trial is for English-speaking pregnant women between 22-25 weeks' gestation facing extremely preterm delivery, and their partners. It's also for maternal-fetal medicine (MFM) or neonatology providers at three specific hospitals. Excluded are non-English speakers, those with fetal malformations, under 18 years old, outside the gestational window, or seeking repeat consultations.

Inclusion Criteria

I am a pregnant woman, speak English, and am expected to deliver extremely preterm.

Practicing MFM or Neonatology provider (attending, fellow, resident, practitioner or RN) from the 3 participating sites: Brigham & Women's Hospital (BWH), Beth Israel Deaconess Medical Center (BIDMC), South Shore Hospital (SSH)

Exclusion Criteria

<22 0/7 or > 25 6/7 weeks' estimated gestation

Non-English proficient

Repeat consultation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention Development

Development of simulation-based educational programs and online training modules for MFM and Neonatology providers

12 months

Implementation and Evaluation

Implementation of educational interventions and evaluation of counseling practices and outcomes

5 years

Follow-up

Participants are monitored for changes in parental and provider anxiety, knowledge, decision making, and satisfaction

5 years

Treatment Details

Interventions

• Educational intervention

Trial Overview The study tests an educational intervention aimed to enhance antenatal counseling by healthcare professionals for families expecting a very premature baby. The focus is on using family-preferred language and advanced communication skills to align with the family's values and foster partnership.

Participant Groups

Group I: Pregnant women and their partners Experimental Treatment 1 Intervention

For the qualitative arm of this mixed method study, using an exploratory sequential design, investigators will enroll \~ 30 adult pregnant women admitted estimated 22 0/7-25 6/7 weeks' estimated gestation and their partners to participate in a post-counseling semi-structured interview to explore preferred language and approaches, and better inform questionnaire development. Sample size will be up to 30 families, or until thematic saturation is achieved (total up to 60 if all partners agree to participate). For the quantitative arm of this study, investigators will enroll \~100 adult pregnant women admitted between estimated 22 0/7-25 6/7 weeks' estimated gestation and their partners (up to total \~200 if all partners present and agree to participate).

Group II: Counseling MFM and Neonatology providers Experimental Treatment 1 Intervention

Investigators will enroll \~100 counseling Maternal-Fetal Medicine (MFM) specialists and 100 counseling Neonatologists (total \~200 providers), who provided counseling to the enrolled pregnant women between 22 0/7-25 6/7 weeks' estimated gestation for anticipated extremely preterm delivery. This assumes 1 counseling provider from MFM and 1 from Neonatology per pregnant woman, although there could be more if a consult is performed by both an attending physician and a training fellow or practitioner, or less, if a counseling provider declines to participate in the study. There will be anticipated repetition of counseling providers, accounted for in the statistical analysis. Providers will be asked to complete educational interventions to improve counseling at extreme prematurity.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

South Shore Hospital

Collaborator

Trials

13

Recruited

10,800+

Findings from Research

A pilot study involving 10 neonatology physicians demonstrated that simulation effectively mimics real-life prenatal counseling scenarios for extremely preterm labor, allowing physicians to reflect on their counseling behaviors.

While physicians provided a lot of biomedical information and expressed empathy, they often did not engage parents in discussing their goals and values, indicating a need for improved communication training in high-stakes medical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"This is a decision you have to make": using simulation to study prenatal counseling. Boss, RD., Donohue, PK., Roter, DL., et al.[2012]

This pilot study used simulation to compare prenatal counseling practices between 11 American and 11 Dutch neonatologists, focusing on counseling for pregnancies at the limits of viability.

The results showed that American neonatologists tended to present multiple treatment options and comfort care more frequently, while Dutch neonatologists were more directive, advocating for specific treatments like partial life support and offering fewer overall options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using simulation to study difficult clinical issues: prenatal counseling at the threshold of viability across American and Dutch cultures. Geurtzen, R., Hogeveen, M., Rajani, AK., et al.[2014]

The PRONTO simulation and team training (STT) significantly improved knowledge and clinical skills related to preterm birth care among maternity unit providers in Kenya and Uganda, with knowledge scores rising from 51% to 73%.

The implementation of STT led to an increase in the performance of evidence-based practices for preterm birth care during simulations, from 55% to 80%, indicating that this training can effectively enhance the quality of care for preterm neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation and team training to improve preterm birth knowledge, evidence-based practices, and communication skills in midwives in Kenya and Uganda: Findings from a pre- and post-intervention analysis. Miller, L., Wanduru, P., Wangia, J., et al.[2023]

A multihospital quality improvement project using in situ simulation training for neonatal resuscitation did not significantly improve the survival rate of preterm infants without chronic lung disease (CLD), with rates remaining stable at around 74.1% to 76.0% over the study period.

Despite the lack of significant improvement in the primary outcome, the stability of secondary outcomes suggests that ongoing simulation training may still positively influence clinical practices and potentially unmeasured outcomes in neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Situ Simulation and Clinical Outcomes in Infants Born Preterm. Chitkara, R., Bennett, M., Bohnert, J., et al.[2023]

A study involving 155 healthcare professionals revealed significant differences in attitudes towards the treatment of extremely preterm infants among neonatal nurses, neonatologists, midwives, and obstetricians, which could lead to confusion for parents during counseling.

Despite these differences, there was a consensus among most professionals that disability does not equate to a reduced quality of life, highlighting the need for improved multidisciplinary training to ensure consistent communication and decision-making support for parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes About Extremely Preterm Birth Among Obstetric and Neonatal Health Care Professionals in England: A Qualitative Study. Gallagher, K., Shaw, C., Parisaei, M., et al.[2023]

A study involving 24 pediatric residents found that a one-time simulation-based education (SBE) session did not significantly improve the skills or performance of junior residents in stabilizing preterm neonates compared to conventional education (CE).

Both groups showed similar knowledge gains and performance scores, indicating that the SBE approach may not be more effective than traditional training methods for this specific task.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation Based vs Conventional Training for Initial Steps in Delivery Room Care of Preterm Neonates: An Open Label Randomized Trial. Neupane, D., Sharma, A., Thukral, A., et al.[2022]

The implementation of a shoulder dystocia simulation program across five academic medical centers has been shown to effectively reduce avoidable patient harm related to neonatal injuries, which are a significant source of liability claims.

Key factors for the successful rollout of the program included strong leadership involvement, administrative support from the insurer, consensus on the curriculum, and ongoing performance tracking, highlighting the importance of collaboration and resource allocation in improving patient safety practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a multicenter shoulder dystocia injury prevention program. Szymanski, L., Arnold, C., Vaught, AJ., et al.[2018]

Simulation training provides a safe and effective way for families and caregivers of medically complex infants to prepare for home care, aligning with patient- and family-centered care principles.

Multidisciplinary collaboration in simulation scenarios enhances learning outcomes and boosts caregivers' confidence, which can lead to improved patient safety and quality of care at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation training for primary caregivers in the neonatal intensive care unit. Arnold, J., Diaz, MC.[2018]

A study involving 61 parents of extremely premature babies revealed that most received counseling primarily from neonatologists, focusing mainly on mortality and short-term morbidity, with only 14% having no counseling at all.

Parents expressed a desire to be involved in decision-making regarding care, but their preferred level of involvement varied, highlighting the need for healthcare providers to understand and accommodate these differing preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Various experiences and preferences of Dutch parents in prenatal counseling in extreme prematurity. Geurtzen, R., Draaisma, J., Hermens, R., et al.[2019]

A scoping review of 46 articles on prenatal counseling for parents at risk of extreme preterm birth highlights that personalization of counseling is a key trend, emphasizing the need to tailor discussions to individual parental values and circumstances.

The review also identifies shared decision-making, emotional support, and addressing uncertainty as critical components of effective prenatal counseling, suggesting that these factors significantly influence the counseling experience for parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal counseling for extreme prematurity at the limit of viability: A scoping review. De Proost, L., Geurtzen, R., Ismaili M'hamdi, H., et al.[2022]

Training clinicians in advanced communication and decision-making skills is essential for effectively counseling families facing the challenges of extreme prematurity, as it can reduce distress for both parents and healthcare providers.

A multidisciplinary approach that includes in-situ simulation and critical reflection has shown promising results in improving antenatal counseling and shared decision-making, highlighting the need for ongoing evaluation and innovation in these educational strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision making at extreme prematurity: Innovation in clinician education. Sullivan, A., Cummings, CL.[2023]

References

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

"This is a decision you have to make": using simulation to study prenatal counseling. [2012]

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

Using simulation to study difficult clinical issues: prenatal counseling at the threshold of viability across American and Dutch cultures. [2014]

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

Simulation and team training to improve preterm birth knowledge, evidence-based practices, and communication skills in midwives in Kenya and Uganda: Findings from a pre- and post-intervention analysis. [2023]

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

In Situ Simulation and Clinical Outcomes in Infants Born Preterm. [2023]

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

Attitudes About Extremely Preterm Birth Among Obstetric and Neonatal Health Care Professionals in England: A Qualitative Study. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Simulation Based vs Conventional Training for Initial Steps in Delivery Room Care of Preterm Neonates: An Open Label Randomized Trial. [2022]

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

Implementation of a multicenter shoulder dystocia injury prevention program. [2018]

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

Simulation training for primary caregivers in the neonatal intensive care unit. [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

Various experiences and preferences of Dutch parents in prenatal counseling in extreme prematurity. [2019]

10. Ireland pubmed.ncbi.nlm.nih.gov

Prenatal counseling for extreme prematurity at the limit of viability: A scoping review. [2022]

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

Decision making at extreme prematurity: Innovation in clinician education. [2023]