Critical Illness, End of Life Care, Palliative Care
Conditions
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
Interventions
BEHAVIORALpalliative 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.
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Family satisfaction | Up to 4 week after death or hospital discharge | Family satisfaction in relatives of adult patients at high risk of death. |
Countries
Chile
Contacts
Primary ContactVerónica Rojas, Msc
Backup ContactAlejandra Palma, MD
Outcome results
None listed