Optimizing Family Counseling for Anticipated Extremely Preterm Delivery

Premature Birth Clinical Trial

Official title:

Optimizing Family Counseling for Anticipated Extremely Preterm Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819933
• Other study ID #: IRB-P00030146
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Boston Children's Hospital
• Contact: Christy L Cummings, MD
• Phone: 617-355-2539
• Email: christy.cummings[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Extremely preterm birth near the limit of viability, defined broadly as birth between 20 and 26 weeks' gestation, accounts for substantial infant morbidity and mortality as well as both parental and provider distress. Prenatal counseling for families anticipating extremely preterm delivery remains ethically and practically challenging for both Maternal Fetal Medicine (MFM) specialists and neonatologists. Physicians must quickly establish a trusting relationship with families and convey complex medical information. They must sensitively elicit family preferences and values regarding life and death, carefully explain management options and potential outcomes such as long-term disability, and arrive at a mutually agreeable plan for delivery and resuscitation. However, prenatal counseling may be disjointed or even contradictory. It has been shown that suboptimal counseling is partially explained by differences in training, practice and perspectives between the specialties, as well as in framing and unconscious biases, time constraints and poor communication. Physicians also often emphasize cognitive information versus parental values when counseling. Preferred language and counseling approaches are largely unknown. This can lead to poor family understanding, inadequate shared decision making, decreased satisfaction and increased anxiety.

There is a need to determine best approaches using language and terminology preferred by families, not physicians. There is also a need to develop new methods to educate MFM and Neonatology providers to improve antenatal counseling. Simulation and enactments are effective in teaching patient-physician communication, ethical dilemmas in medicine, and prenatal counseling. This mixed-methods behavioral intervention study 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, focusing on eliciting values and building partnerships through advanced communication and relational skills, to improve counseling practices and outcomes.

The overall hypothesis is that family-focused counseling at extreme prematurity by providers trained in using language and approaches preferred by families will more effectively address parents' values and preferences central to decision making and improve counseling practices and outcomes. In this mixed-methods study, the investigators will enroll ~130 families and their counseling providers from MFM and Neonatology and compare family-focused counseling outcomes after educational interventions to baseline. Investigators will collaborate with Family Faculty advisors from study design through publication to incorporate the parental perspective.

Aim 1a: To determine, via semi-structured interviews of up to 30 families, preferred language, terminology and approach, including maternal/paternal differences, during family counseling for impending extremely preterm delivery, following standard counseling. Aim 1b: To establish baseline understanding, perceptions, decision making, and anxiety of 50 families and their counseling providers measured via survey, including the Controlled Preferences Scale-Pediatrics, Decisional Conflict Scale, and State Trait Anxiety Inventory (STAI). Secondary hypothesis: maternal/paternal preferences for language, involvement and decision making differ.

Aim 2a: To develop a novel, joint-specialty simulation-based workshop for MFMs and neonatologists through Boston Children Hospital's (BCH) established Simulation Pediatric Program and Institute for Professionalism and Ethical Practice (IPEP). Aim 2b: To create an innovative, multi-media online training module for MFMs and neonatologists through BCH Simulation Pediatric/IPEP and Open PediatricsTM, a free and globally accessible web-based teaching platform to enable widespread dissemination. Both products will use preferred language and approaches from a national survey by investigators (in progress) and Aim 1, while emphasizing interdisciplinary communication, ethical and relational skills, addressing biases, and focusing on family values and preferences central to decision making.

Aim 3: To evaluate whether developed educational interventions improve counseling practices and outcomes on repeat surveys of 50 families and trained counseling providers using comparative statistical analyses. Primary hypothesis: counseling by trained providers will improve parental 1) understanding, 2) perceptions, 3) decision making, and 4) anxiety, by improving communication and more effectively addressing parents' values and preferences central to decision making. Secondary hypotheses: 1) the online module will be as effective as the workshop; 2) trained providers will report increased comfort and decreased anxiety when counseling.

Given the weight of decisions resulting from family counseling for impending extremely preterm delivery, joint-specialty interventions using preferred language and approach to optimize counseling are urgently needed. These innovative educational interventions present a feasible and effective approach that can be widely disseminated to improve interdisciplinary family-focused counseling for anticipated extremely preterm deliveries and counseling outcomes, representing a direct and immediate clinical impact.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: June 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

1. Pregnant women and their partners

Inclusion Criteria:

• 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

Exclusion Criteria:

• Non-English proficient

• Fetal congenital malformation(s)

• <18y old

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

• Repeat consultation

2. Counseling MFM and Neonatology providers

Inclusion Criteria:

• 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:

• None

Related Conditions & MeSH terms

• Premature Birth
• Preterm Pregnancy

Intervention

Behavioral:
• Educational intervention
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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Children's Hosptial	Boston	Massachusetts
United States	South Shore Hospital	Weymouth	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston Children's Hospital	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, South Shore Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Maternal versus Paternal/Partner preferences	The Parental Questionnaire includes questions asking about parental preferences for language, involvement and decision making at extreme prematurity, including the CPS-P and ODCS (see above), to detect any maternal versus paternal/partner differences. 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.	3 years
Secondary	Effect of Educational Interventions	The Parental and Provider Questionnaires include questions asking about parental and provider knowledge, satisfaction, decision making, anxiety (tools described above) regarding counseling at extreme prematurity to determine whether developed educational interventions for providers (workshop, online module or both) improve counseling practices and outcomes using comparative statistical analyses. 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.	2 years
Secondary	Provider anxiety	The Provider Questionnaire includes the State Trait Anxiety Inventory (STAI) to assess provider anxiety when counseling at extreme prematurity 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