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

University of Chile

Status: Enrolling

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

Treatments: Behavioral: palliative care protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06483958

OAIC 1315/22

Details and patient eligibility

About

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.

Full 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

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

Intervention

Experimental group

Description:

Palliative care protocol

Treatment:

Behavioral: palliative care protocol

Standard care

No Intervention group

Description:

None intervention