Optimizing Family Counseling for Anticipated Extremely Preterm Delivery

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT03819933
Status
Recruiting
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Conditions

  • Premature Birth
  • Preterm Pregnancy

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Educational intervention — BEHAVIORAL
    Investigators will first determine preferred language and approaches by families, then redefine current training for prenatal counseling at extreme prematurity by developing and implementing two novel, interdisciplinary simulation-based educational programs for MFM and Neonatology (a workshop and an online module), focusing on eliciting values and building partnerships through advanced communication and relational skills, to improve counseling practices and outcomes

Study Details

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.

Key Dates

Start date
Sep 17, 2019
Status verified
Dec 2025
Primary completion
Aug 1, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
460 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

Arms

  • Other: Pregnant women and their partners
    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).
  • Other: Counseling MFM and Neonatology providers
    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.

Primary Outcome Measure

Parental knowledge [ Time Frame: 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
John Zupancic, MD
[email protected]
6176673276
Boston Children's HosptialBostonMassachusetts02115
Christy Cummings, MD
[email protected]
6173552539
South Shore HospitalWeymouthMassachusetts02190
Bonnie Arzuaga, MD
[email protected]
6173554647

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