Palliative Care Protocol for Adult Patients Hospitalized in Critical Care Units.

NCT06483958 | Unknown DMC

• 1 other identifier: OAIC 1315/22
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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. 1.Symptom management.
2. 2.Respect for the autonomy of the patient and his/her family environment.
3. 3.Respectful management of clinical information.
4. 4.Provision of holistic care and support.

Conditions

End of Life Care; Critical Illness; Palliative Care

Outcome Measures

Primary Outcomes (1)

• Burden of symptoms present in the last 24 hours prior to death (or end of follow-up).

  The percentage of patients with at least one episode of pain, dyspnea, agitation, or anxiety

  From recruitment until death or day 5 of follow up

Secondary Outcomes (1)

• Family satisfaction

  Up to 4 week after death or hospital discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Palliative care protocol

Behavioral: palliative care protocol

Standard care

NO INTERVENTION

None intervention

Interventions

palliative care protocol BEHAVIORAL

1. Symptom management 2. Respect for patient and family autonomy. 3. Respectful management of clinical information. 4. Provision of holistic care and support.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and older
• Hospitalization in critical care unit for more than 48 hrs.
• Medical indication of therapeutic effort limitation, defined as: a) Non-initiation or withdrawal of life support therapies: invasive mechanical ventilation, vasoactive drugs, cardiopulmonary resuscitation, renal replacement therapy.

You may not qualify if:

• Severe communication disorder and cultural language limitation (language other than Spanish).
• Absence of legal representative and/or caregiver.
• Brain dead patient.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Verónica Rojas

Santiago, Me, 8380420, Chile

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Verónica Rojas, Msc

CONTACT

+56976488006; verorojas@uchile.cl

Alejandra Palma, MD

CONTACT

apalmabehnke@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: January 2, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 30, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)