Clinical trial NCT03819933: Optimizing Family Counseling for Anticipated Extremely Preterm Delivery
Official title: Optimizing Family Counseling for Anticipated Extremely Preterm Delivery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Pregnancy
Premature Birth
Keywords: Counseling
Extreme Prematurity
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: South Shore Hospital
First posted: 2019-01-29
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Parental knowledge
timeFrame: 5 years
measure: Parental satisfaction: The Parental Questionnaire
timeFrame: 5 years
measure: Parental decision making
timeFrame: 5 years
measure: Parental anxiety
timeFrame: 5 years
measure: Parental preferred language and terminology
timeFrame: 5 years
Secondary outcomes:
measure: Maternal versus Paternal/Partner preferences
timeFrame: 3 years
measure: Effect of Educational Interventions
timeFrame: 2 years
measure: Provider anxiety
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hosptial
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Christy Cummings
role: PRINCIPAL_INVESTIGATOR
References: