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

June 26, 2024 updated by: University of Chile

Palliative Care Protocol for Adult Patients at High Risk of Death in Critical Care Units: A Multicentric Stepped Wedge Cluster Randomised Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Palliative care protocol
Behavioral: 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.
No Intervention: Standard care
None intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burden of symptoms present in the last 24 hours prior to death (or end of follow-up).
Time Frame: 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
From recruitment until death or day 5 of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family satisfaction
Time Frame: Up to 4 week after death or hospital discharge
Family satisfaction in relatives of adult patients at high risk of death.
Up to 4 week after death or hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAIC 1315/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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