The Periviable GOALS Decision Support Tool
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Periviable GOALS DST.
- Кому может быть актуально
- Состояния в реестре: Pregnancy Preterm, Premature Birth, Pregnancy Complications, Obstetric Labor, Premature. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Promoting Shared Decision Making in Periviable Care: A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool
Обзор
The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0/7 - 25 6/7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.
Подробное описание
The investigators will evaluate the Periviable GOALS DST in a randomized controlled trial among 144 pregnant patients between 22 0/7 and 25 6/7 weeks gestation who are hospitalized for a pregnancy complication that threatens periviable delivery. Pregnant patients agreeing to participate will be asked to identify whom they will primarily rely on for assistance in making decisions regarding their delivery plan (e.g., father of the baby, partner, a family member, or any other important individual in the patient's life), referred to as the 'important other' (IO). In terms of IO recruitment goals, the investigators anticipate recruiting 72 IOs. This goal is based on our previous work with a similar population of pregnant patients, in which about half identified an 'important other' to be included in the study.
Recruitment will be conducted at Indiana University (IU), the University of California at San Francisco (UCSF), the University of Kansas, the University of California at San Diego (UCSD), Northwestern University, The Ohio State University (OSU), the University of Pennsylvania (UPenn), The University of Texas at Austin (UTA), Yale University, University of Massachusetts (UMass), the University of Kentucky (UK), and Brown University.
This study consists of 3-4 points of data collection, depending on group assignment. Participants will be randomized into a treatment group or control group at the start of the study. All participants will complete the T0 interview, which consists of a set of baseline questionnaires and survey instruments that will be administered in-person, prior to delivery and after they have been counseled on their neonatal treatment options. Immediately following T0, participants who are assigned to the control group will proceed with usual care. Participants who are randomized to the intervention will review the Periviable GOALS DST, which contains outcomes information, values clarification and embedded short documentary style videos. The content focuses largely on helping patients better understand the choice they have between comfort care and life-sustaining efforts in the context of periviable delivery. After viewing the DST, participants will repeat instruments from T0 and provide feedback regarding the tool's acceptability (T1). Another member of the research team will contact all participants to complete follow-up interviews to assess decision quality, neonatal treatment preference and outcome, and mental health. These interviews will be conducted on postpartum day 1 or 2 (T2), at three months postpartum (T3), and at six months postpartum (T4).
Вмешательства
- Другое Periviable GOALS DST
An iPad application that contains outcomes information, values clarification and embedded short documentary style videos. The tool was designed with low-literacy and low-numeracy populations in mind, and utilizes graphics and video content to enhance meaning-making of complex medical information and jargon. The GOALS DST refers patients back to their physicians to discuss specific treatment options, local outcomes, and management strategies available to them. The DST's content focuses largely on
Первичные конечные точки
- Shared Decision Making [Срок оценки: 1 day to 2 weeks after delivery]
- Decision Satisfaction [Срок оценки: 1 day to 2 weeks after delivery]
Вторичные конечные точки (12)
- Decisional Conflict [Срок оценки: 1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery]
- Knowledge about Periviable Delivery [Срок оценки: Before delivery]
- Decision Regret [Срок оценки: 1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery]
- Decision Control [Срок оценки: 1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery]
- Depression [Срок оценки: Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.]
- Anxiety [Срок оценки: Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.]
- Post-Traumatic Stress Disorder [Срок оценки: Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.]
- Number of Parents who Preferred Resuscitation vs. Palliation [Срок оценки: Before delivery and 1-2 days after delivery]
- Neonatal Treatment Provided [Срок оценки: Up to 6 months after delivery]
- Neonatal Outcome [Срок оценки: Up to 6 months after delivery]
- Acceptability of the decision support tool [Срок оценки: Before delivery]
- Preparation for Decision Making [Срок оценки: Before delivery]
Критерии участия
Inclusion Criteria for Pregnant Persons:
- Adults (18 years or older)
- Pregnant between 22 0/7 to 25 6/7 weeks gestation (this window may be slightly different for each recruitment site, as the gestational window that defines periviable delivery varies by institution).
- Presenting to Labor \& Delivery at an approved study site with a pregnancy complication that poses the potential threat of or need for periviable delivery (e.g., rupture of membranes, preterm labor, shortened cervix, pre-eclampsia, and growth restriction).
- Must have been counseled on their neonatal treatment options (e.g. resuscitation, comfort care) by their healthcare team prior to being approached by the study team.
Inclusion Criteria for Important Others:
- Adults (18 years or older)
- 1 per pregnant person
- Is identified by the pregnant person as someone who will be involved in making decisions for the baby
- Must be present at the time of randomization to participate
Критерии исключения
- Under 18 years of age
- Incarcerated
- Medically unstable (i.e. in active labor and dilated 6cm or more)
- Emotionally unstable
- Have not been counseled by their healthcare team regarding neonatal treatment options
- Are not admitted to Labor \& Delivery for reasons indicative of a threatened early delivery
- If they are experiencing a known fatal fetal anomaly
- Are not present at the time of randomization (only for important others)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 12 центров
- The University of California San Diego — San Diego
- University of California San Francisco — San Francisco
- Yale University — New Haven
- Northwestern University — Chicago
- Indiana University — Indianapolis
- The University of Kansas Medical Center — Kansas City
- The University of Kentucky — Lexington
- University of Massachusetts — Worcester
- … и ещё 4 центра
Идентификаторы
NCT: NCT05264779 · R01HS028001