Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 12:02 PM
Study NCT ID:
NCT06483958
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care Protocol for Adult Patients Hospitalized in Critical Care Units.
Sponsor:
University of Chile
Organization:
Study Overview
Official Title:
Palliative Care Protocol for Adult Patients at High Risk of Death in Critical Care Units: A Multicentric Stepped Wedge Cluster Randomised Trial
Status:
RECRUITING
Status Verified Date:
2024-01
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 goal of this clinical trial is to determine the effectiveness of a palliative care protocol in improving the quality of care of adult patients at high risk of dying hospitalized in the critical care unit.
Assessing symptom burden (dyspnea, pain and/or anxiety/agitation) until death or day 5 (whichever comes first)
Researchers will compare the impact of the palliative care protocol with standard care to see if it improves the quality of care.
Participants will:
1. Symptom management.
2. Respect for the autonomy of the patient and his/her family environment.
3. Respectful management of clinical information.
4. Provision of holistic care and support.
Assessing symptom burden (dyspnea, pain and/or anxiety/agitation) until death or day 5 (whichever comes first)
Researchers will compare the impact of the palliative care protocol with standard care to see if it improves the quality of care.
Participants will:
1. Symptom management.
2. Respect for the autonomy of the patient and his/her family environment.
3. Respectful management of clinical information.
4. Provision of holistic care and support.
Detailed Description:
We designed a stepped wedge cluster randomized trial The study is implementation in 5 Chilean hospitals, admitting 248 patients.
Pre-intervention (control): The practices of each ICU will be maintained, until the moment that according to randomization corresponds the beginning of the intervention, in each center.
Post-intervention: Palliative care protocol to improve the quality of care
Pre-intervention (control): The practices of each ICU will be maintained, until the moment that according to randomization corresponds the beginning of the intervention, in each center.
Post-intervention: Palliative care protocol to improve the quality of care
Study Oversight
Has Oversight DMC:
True
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?: