Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05264779
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2021-12-06
Brief Title:
The Periviable GOALS Decision Support Tool
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Promoting Shared Decision Making in Periviable Care A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 07 - 25 67 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
Detailed Description:
The investigators will evaluate the Periviable GOALS DST in a randomized controlled trial among 144 pregnant patients between 22 07 and 25 67 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 eg father of the baby partner a family member or any other important individual in the patients 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 and the University of Pennsylvania UPenn
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 tools 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
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 and the University of Pennsylvania UPenn
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 tools 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None