Palliative Care Protocol for Adult Patients at High Risk of Death in Critical Care Units: A Multicentric Stepped Wedge Cluster Randomised Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End of Life Care
- Sponsor
- University of Chile
- Enrollment
- 248
- Locations
- 1
- Primary Endpoint
- Burden of symptoms present in the last 24 hours prior to death (or end of follow-up).
- Status
- Recruiting
- Last Updated
- last year
Overview
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:
- 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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Family satisfaction(Up to 4 week after death or hospital discharge)