Optimizing Family Counseling for Anticipated Extremely Preterm Delivery

NCT03819933 | Recruiting DMC

• 1 other identifier: IRB-P00030146
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Preterm Pregnancy; Premature Birth

Keywords

Counseling; Extreme Prematurity

Outcome Measures

Primary Outcomes (5)

• Parental knowledge

  The Parental Questionnaire includes questions asking about parental knowledge and understanding about extremely preterm deliveries and clinical outcomes post-counseling to assess parental knowledge and compare pre/post educational interventions. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging "Not at all" to "Extremely" for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.

  5 years

• Parental satisfaction: The Parental Questionnaire

  The Parental Questionnaire includes questions asking about parental satisfaction and perceptions post-counseling to compare pre/post educational interventions. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging "Not at all" to "Extremely" for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.

  5 years

• Parental decision making

  The Parental Questionnaire includes the Controlled Preferences Scale-Pediatrics (CPS-P) and the Ottawa Decisional Conflict Scale (ODCS) to assess parental decision making and compare pre/post educational interventions. The CPS-P is a validated, reliable tool adapted for use in pediatrics to assess parental preferences for participation in decision making and consists of 5 statements describing various roles in decision making, ranging from passive ("I prefer to leave all decisions regarding my child's treatment to my doctor") to active ("I prefer to make the final decision about which treatment my child will receive"), to collaborative. The ODCS is a validated 16-item tool with 5 response categories that measures personal perceptions of decision making. Each of the 16 DCS items is given a score value ranging 0-4, which are summed, divided by 16, and multiplied by 25, yielding a total score ranging from 0-100 (no decisional conflict - extremely high decisional conflict).

  5 years

• Parental anxiety

  The Parental Questionnaire includes the State Trait Anxiety Inventory (STAI) to assess parental anxiety and compare pre/post educational interventions. The Spielberger State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait (baseline) and state (present) anxiety, used in clinical research to detect patient and caregiver changes in state of anxiety.58-61 In the third section of the Parental Questionnaire, participants will be asked 20 questions from the STAI, which is appropriate for participants with at least a 6th grade reading level, to measure current levels of anxiety, as opposed to a tendency towards anxiety at baseline. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." All items are rated on a 4-point scale, ranging from "Almost Never" to "Almost Always," with higher scores indicating greater anxiety.

  5 years

• Parental preferred language and terminology

  The Parental Questionnaire includes questions asking about preferred parental language and terminology when counseling at extreme prematurity. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging "Not at all" to "Extremely" for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.

  5 years

Secondary Outcomes (3)

• Maternal versus Paternal/Partner preferences

  3 years

• Effect of Educational Interventions

  2 years

• Provider anxiety

  5 years

Study Arms (2)

Pregnant women and their partners

OTHER

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).

Behavioral: Educational intervention

Counseling MFM and Neonatology providers

OTHER

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.

Behavioral: Educational intervention

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

Counseling MFM and Neonatology providers; Pregnant women and their partners

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-proficient adult pregnant woman admitted between 22 0/7-25 6/7 weeks' estimated gestation for anticipated extremely preterm delivery and her adult partner (if available) for whom an antenatal neonatal intensive care unit (NICU) consultation was requested and performed

You may not qualify if:

• Non-English proficient
• Fetal congenital malformation(s)
• \<18y old
• \<22 0/7 or \> 25 6/7 weeks' estimated gestation
• Repeat consultation
• Counseling MFM and Neonatology providers
• 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)
• None

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• South Shore Hospital: collaborator

Study Sites (3)

Boston Children's Hosptial

Boston, Massachusetts, 02115, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Christy Cummings

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy L Cummings, MD

CONTACT

617-355-2539; christy.cummings@childrens.harvard.edu

Vanessa J Young, RN, BA

CONTACT

617-355-8330; vanessa.young@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: There will be no masking in this behavioral intervention trial.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: This pre/post, mixed method behavioral intervention study will enroll \~130 families (pregnant women and their partners) at extreme prematurity and their counseling providers from Maternal Fetal Medicine (MFM) and Neonatology (total possible participants \~460) to determine whether developed educational interventions for providers (workshop, online module or both) improve counseling practices and outcomes using comparative statistical analyses.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 29, 2019
• Study Start: September 17, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (3)