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

Not Applicable

Recruiting

• Conditions: Palliative Care; End of Life Care; Critical Illness

• Registration Number: NCT06483958
• Lead Sponsor: University of Chile

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.

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

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-02
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Last Update Submitted: 2024-06-26
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

• 18 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Burden of symptoms present in the last 24 hours prior to death (or end of follow-up).	From recruitment until death or day 5 of follow up	The percentage of patients with at least one episode of pain, dyspnea, agitation, or anxiety

Secondary Outcome Measures

Name	Time	Method
Family satisfaction	Up to 4 week after death or hospital discharge	Family satisfaction in relatives of adult patients at high risk of death.

Trial Locations

Locations (1)

Verónica Rojas; 🇨🇱 Santiago, Me, Chile