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

Not Applicable

Recruiting

• Conditions: Palliative Care; End of Life Care; Critical Illness
• Interventions: Behavioral: palliative care protocol

• 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

Arm && Interventions

Group	Intervention	Description
Intervention	palliative care protocol	Palliative care protocol

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