End of Life CareNCT06483958
Palliative Care Protocol for Adult Patients Hospitalized in Critical Care Units.
A study testing palliative care protocol in people with End of Life Care and Critical Illness, run by University of Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End of Life Care, Critical Illness, Palliative Care
- What is being tested?
- palliative care protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChile
- Study dates
- 2 Jan 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe communication disorder and cultural language limitation (language other than Spanish).
- Absence of legal representative and/or caregiver.
- Brain dead patient.
Trial locations and contacts
1 site in 1 country.
Alejandra Palma, MD contact
Chile1 site, 1 recruiting
- Recruiting
Verónica Rojas
Santiago, Me, 8380420
Verónica Rojas, Msc, verorojas@uchile.cl
A Palma, Msc, apalmabehnke@gmail.com
About this study
Official title: 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:
- Symptom management.
- Respect for the autonomy of the patient and his/her family environment.
- Respectful management of clinical information.
- Provision of holistic care and support.
Read the 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
- Conditions
- End of Life Care, Critical Illness, Palliative Care
- Being tested
- palliative care protocol
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palliative care protocolBehavioural
- Symptom management
- Respect for patient and family autonomy.
- Respectful management of clinical information.
- Provision of holistic care and support.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Palliative care protocol Receives: Behavioral: palliative care protocol |
| Standard care | No intervention | None intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden of symptoms present in the last 24 hours prior to death (or end of follow-up).
The percentage of patients with at least one episode of pain, dyspnea, agitation, or anxiety
Measured: From recruitment until death or day 5 of follow up
Secondary outcomes (1)
Family satisfaction
Family satisfaction in relatives of adult patients at high risk of death.
Measured: Up to 4 week after death or hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start2 Jan 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End of Life CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483958
- Sponsor's protocol ID
- OAIC 1315/22
- Status last verified
- Jan 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care Protocol for Adult Patients at High Risk of Death in Critical Care Units: A Multicentric Stepped Wedge Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT06483958
- Acronym / sponsor ID
- OAIC 1315/22
- Conditions
- End of Life Care, Critical Illness, Palliative Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Symptom management.
- Respect for the autonomy of the patient and his/her family environment.
- Respectful management of clinical information.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: palliative care protocolPalliative care protocol |
| Standard care | No intervention | –None intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Severe communication disorder and cultural language limitation (language other than Spanish).
- Absence of legal representative and/or caregiver.
- Brain dead patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palliative care protocol1. Symptom management 2. Respect for patient and family autonomy. 3. Respectful management of clinical information. 4. Provision of holistic care and support. | Behavioural | Intervention |
Primary outcome
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
1 secondary outcome
Family satisfaction
Time frame: Up to 4 week after death or hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandra Palma, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palliative care protocol in people with End of Life Care and Critical Illness, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Verónica Rojas, Msc (+56976488006, verorojas@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.