Family Counseling Education for Preterm Birth
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Children's Hospital
Disqualifiers: Non-English proficient, Fetal malformation, others
No Placebo Group
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.
12345Is 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.
23678How 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.
1891011Eligibility 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
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Pregnant women and their partnersExperimental Treatment1 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 providersExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HosptialBoston, MA
Beth Israel Deaconess Medical CenterBoston, MA
South Shore HospitalWeymouth, MA
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Who Is Running the Clinical Trial?
Boston Children's HospitalLead Sponsor
Beth Israel Deaconess Medical CenterCollaborator
Brigham and Women's HospitalCollaborator
South Shore HospitalCollaborator
References
"This is a decision you have to make": using simulation to study prenatal counseling. [2012]Prenatal decision making during extremely preterm labor is challenging for parents and physicians. Ethical and logistical concerns have limited empirical descriptions of physician counseling behaviors in this setting and constricted opportunities for communication training. This pilot study examines how simulation might be used to engage neonatologists in reflecting on their usual prenatal counseling behaviors.
Using simulation to study difficult clinical issues: prenatal counseling at the threshold of viability across American and Dutch cultures. [2014]Prenatal counseling at the threshold of viability is a challenging yet critically important activity, and care guidelines differ across cultures. Studying how this task is performed in the actual clinical environment is extremely difficult. In this pilot study, we used simulation as a methodology with 2 aims as follows: first, to explore the use of simulation incorporating a standardized pregnant patient as an investigative methodology and, second, to determine similarities and differences in content and style of prenatal counseling between American and Dutch neonatologists.
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]Simulation training in basic and emergency obstetric and neonatal care has previously shown success in reducing maternal and neonatal mortality in low-resource settings. Though preterm birth is the leading cause of neonatal deaths, application of this training methodology geared specifically towards reducing preterm birth mortality and morbidity has not yet been implemented and evaluated. The East Africa Preterm Birth Initiative (PTBi-EA) was a multi-country cluster randomized controlled (CRCT) trial that successfully improved outcomes of preterm neonates in Migori County, Kenya and the Busoga region of Uganda through an intrapartum package of interventions. PRONTO simulation and team training (STT) was one component of this package and was introduced to maternity unit providers in 13 facilities. This analysis was nested within the larger CRCT and specifically looked at the impact of the STT portion of the intervention package. The PRONTO STT curriculum was modified to emphasize prematurity-related intrapartum and immediate postnatal care practices, such as assessment of gestational age, identification of preterm labour, and administration of antenatal corticosteroids. Knowledge and communication techniques were assessed at the beginning and end of the intervention through a multiple-choice knowledge test. Clinical skills and communication techniques used in context were assessed through the use of evidence-based practiced (EBPs) as documented in video-recorded simulations through StudioCodeTM video analysis. Pre-and-post scores were compared in both categories using Chi-squared tests. Knowledge assessment scores improved from 51% to 73% with maternal-related questions improving from 61% to 74%, neonatal questions from 55% to 73%, and communication technique questions from 31% to 71%. The portion of indicated preterm birth EBPs performed in simulation increased from 55% to 80% with maternal-related EBPs improving from 48% to 73%, neonatal-related EBPs from 63% to 93%, and communication techniques from 52% to 69%. STT substantially increased preterm birth-specific knowledge and EBPs performed in simulation.
In Situ Simulation and Clinical Outcomes in Infants Born Preterm. [2023]To evaluate impact of a multihospital collaborative quality improvement project implementing in situ simulation training for neonatal resuscitation on clinical outcomes for infants born preterm.
Attitudes About Extremely Preterm Birth Among Obstetric and Neonatal Health Care Professionals in England: A Qualitative Study. [2023]Variation in attitudes between health care professionals involved in the counseling of parents facing extremely preterm birth (
Simulation Based vs Conventional Training for Initial Steps in Delivery Room Care of Preterm Neonates: An Open Label Randomized Trial. [2022]To assess whether simulation based education (SBE) improves the practices and knowledge of junior residents for stabilization of a preterm neonate in delivery room as compared to conventional education (CE).
Implementation of a multicenter shoulder dystocia injury prevention program. [2018]Although the evidence for supporting the effectiveness of many patient safety practices has increased in recent years, the ability to implement programs to positively impact clinical outcomes across multiple institutions is lagging. Shoulder dystocia simulation has been shown to reduce avoidable patient harm. Neonatal injury from shoulder dystocia contributes to a significant percentage of liability claims. We describe the development and the process of implementation of a shoulder dystocia simulation program across five academic medical centers and their affiliated hospitals united by a common insurance carrier. Key factors in successful roll out of this program included the following: involvement of physician and nursing leadership from each academic medical center; administrative and logistic support from the insurer; development of consensus on curriculum components of the program; conduct of gap and barrier analysis; financial support from insurer to close necessary gaps and mitigate barriers; and creation of dashboards and tracking performance of the program.
Simulation training for primary caregivers in the neonatal intensive care unit. [2018]Simulation is a hands-on educational modality that creates a safe, confidential learning environment that is closely aligned with the principles of patient- and family-centered care. This makes it an ideal training tool for families and caregivers of medically complex infants as they prepare for their care at home. Multidisciplinary collaboration and participation is vital to the success of these simulations and encourages the development of needs assessments and learning objectives that are congruent with the family's goals, beliefs, and culture. Simulation scenarios and curricula may be tailored and delivered in ways that optimize learning and allow for outcomes to be measured. Debriefing with specific and supportive feedback may increase families' and caregivers' confidence in handling their child's medical issues. This may lead to improved patient safety and quality of care delivered in the home environment.
Various experiences and preferences of Dutch parents in prenatal counseling in extreme prematurity. [2019]To investigate experienced and preferred prenatal counseling among parents of extremely premature babies.
Prenatal counseling for extreme prematurity at the limit of viability: A scoping review. [2022]To explore, based on the existing body of literature, main characteristics of prenatal counseling for parents at risk for extreme preterm birth.
Decision making at extreme prematurity: Innovation in clinician education. [2023]Decision-making at extreme prematurity remains ethically and practically challenging and can result in parental and clinician distress. It is vital that clinicians learn the necessary skills integral to counseling and decision-making with families in these situations. A pedagogical approach to teaching counseling should incorporate adult learning theory, emphasize multidisciplinary team in-situ simulation that links to counseling clinicians' daily practice, and includes critical reflection, debriefing, and program assessment. Multiple educational strategies that train clinicians in advanced communication and decision-making offer promising results to optimize antenatal counseling and shared decision-making for families facing possible delivery at extreme prematurity. Continued process evaluation and innovation in these educational domains are needed while also assessing the effect on patient-centered outcomes.