Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-13 @ 11:36 AM
Study NCT ID:
NCT01751061
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2012-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Decision Making for Patients With Prolonged Mechanical Ventilation
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Improving Decision Making for Patients With Prolonged Mechanical Ventilation
Status:
COMPLETED
Status Verified Date:
2019-04
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:
Deciding about prolonged life support for critically ill patients can be very difficult. Therefore, the investigators are doing a study to see if an internet-based decision aid can improve the quality of decision making for substitute decision makers of patients who are in the intensive care unit (ICU).
Detailed Description:
The process of making a decision about whether or not to provide prolonged life support is seriously deficient among clinicians and the surrogate decision makers for critically ill patients. To address this problem, we propose a randomized, controlled trial to determine if an innovative web-based decision aid compared to usual care control can improve the quality of decision making (defined as clinician-surrogate concordance for prognosis, quality of communication, and medical comprehension), reduce surrogates' psychological distress (depression, anxiety, and post-traumatic stress syndrome disorder (PTSD) symptoms), and reduce patients' health care costs over 6-month follow up. We will enroll 410 surrogate decision makers for 273 patients (expected average of 1.5 surrogates per patient). This study has the potential both to improve how clinicians and surrogates interact in intensive care units and to increase the likelihood that life support decisions are aligned with patients' values.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL109823-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |