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

NCT ID: NCT06483958

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2025-12-30

Brief Summary

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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

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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

Conditions

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End of Life Care Critical Illness Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Palliative care protocol

Group Type EXPERIMENTAL

palliative care protocol

Intervention Type BEHAVIORAL

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

Standard care

None intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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palliative care protocol

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Verónica Rojas

Santiago, Me, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Verónica Rojas, Msc

Role: CONTACT

+56976488006

Alejandra Palma, MD

Role: CONTACT

Facility Contacts

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Verónica Rojas, Msc

Role: primary

A Palma, Msc

Role: backup

Other Identifiers

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OAIC 1315/22

Identifier Type: -

Identifier Source: org_study_id

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