Promoting Shared Decision Making in Periviable Care: A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 22
- 主要终点
- Shared Decision Making
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The assessors of the primary outcome will be blinded to the participant's treatment group. The investigators will utilize a two-research assistant (RA) recruitment approach, wherein one RA collects the T0/T1 information and randomizes the patient to a study arm; and a second RA collects the T2-T4 data, remaining a blinded assessor of the primary outcomes of interest. Further, all other research personnel, including the data manager, statistician, and study investigators will be blinded to the participant's treatment group to minimize the potential for bias in the analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Usual Care (control)
Participants assigned to this group will proceed with usual medical care and treatment, consisting of counseling by the teams of obstetricians and/or neonatologists at the respective study sites.
Periviable GOALS DST Group
Participants randomized to the intervention will be presented with the Periviable GOALS DST and instructed to review the DST in its entirety. The participant will complete the education and values clarification components of the DST with the Recruitment RA present to confirm completion. Following completion of the GOALS DST, the Recruitment RA will repeat knowledge and decisional conflict instruments and assess acceptability.
干预措施: Periviable GOALS DST (Other)
结局指标
主要结局
Shared Decision Making
时间窗: 1 day to 2 weeks after delivery
9-item Shared Decision Making Questionnaire (SDM-Q-9) administered in-person or via phone/Zoom call. Scores range from 0 to 100, with a higher score correlating to higher shared decision making.
Decision Satisfaction
时间窗: 1 day to 2 weeks after delivery
6-item Satisfaction with Decision Scale, administered in-person or via phone/Zoom call at three time points. There are 5 response categories ranging from 1 (strongly disagree) to 5 (strongly agree) with higher scores correlating to higher decision satisfaction.
次要结局
- Decision Control(1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery)
- Depression(Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.)
- Number of Parents who Preferred Resuscitation vs. Palliation(Before delivery and 1-2 days after delivery)
- Decisional Conflict(1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery)
- Knowledge about Periviable Delivery(Before delivery)
- Neonatal Treatment Provided(Up to 6 months after delivery)
- Preparation for Decision Making(Before delivery)
- Decision Regret(1 day to 2 weeks after delivery, 3 months after delivery, and 6 months after delivery)
- Anxiety(Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.)
- Post-Traumatic Stress Disorder(Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.)
- Neonatal Outcome(Up to 6 months after delivery)
- Acceptability of the decision support tool(Before delivery)
- Decision Satisfaction(3 months and 6 months after delivery)
研究者
Brownsyne Tucker Edmonds
Associate Professor of Obstetrics and Gynecology and Clinical Pediatrics
Indiana University