Proactive Palliative Care Intervention in a Surgical ICU: Influence on Family Satisfaction and Patient Distress

Study Overview
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Brief Summary
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Patients will be identified according to pre-defined trigger criteria for a palliative intervention. One hundred patients of a control group will receive standard intensive care treatment (Usual Care Group). Patients' biopsychosocial problem-related distress will be evaluated and family satisfaction with intensive care will be measured with standardized questionnaires. In the subsequent intervention part of the study one hundred patients will additionally be offered a palliative care treatment (Proactive Care Group) and patients' biopsychosocial problem-related distress as well as family satisfaction will also be evaluated.

Detailed Description
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The project consists of different consecutive parts: Trigger criteria: Trigger criteria for patients with unmet palliative care needs in an intensive care unit have been specified prior to start of the clinical study by survey of staff of the surgical intensive care unit (intensivists and nursing staff): Trigger criteria include a) advanced cancer, b) multi-organ failure, c) severe cognitive impairment or dementia Clinical study: Proactive palliative care intervention vs. standard care for intensive care patients. Initially patients fulfilling the defined trigger criteria will be enrolled in the standard care group (Group 1). In the intervention part of the study, enrolled patients will be offered a set of different palliative care interventions in addition to standard intensive care (Group 2). In both groups, family satisfaction will be evaluated with the FS-ICU-24 (Family Satisfaction Intensive Care) questionnaire after discharge of the patients from the ICU. 8 weeks (60 days +/- 7 days) after inclusion in the study, patients' biopsychosocial distress will be assessed with standardized patient questionnaires (NCCN Distress thermometer, PHQ-2 Patient Health Questionnaire). One year after inclusion in the study, patients' functional status will be evaluated in a telephone interview using the Barthel Index. Planned duration of clinical part of the study: 3 years, thereof Patient-related: Duration of palliative care intervention: approx. 60 mins for each patient contact. The number of interventions depends on the duration of ICU stay per patient. Follow-up per patient until 1 year after enrolment. Study-related: The clinical study starts with the enrollment of the first ICU patient. Data will be collected between the admission of the patient in the ICU until discharge from ICU and hospital discharge, respectively. Follow-up visits will be performed 8 weeks and 1 year after enrolment. Patients will be recruited over an estimated period of approx. 3 years, assuming that 1-2 patients per week can be included. Follow-up data will be collected up to 1 year after last patient in. Termination of study including data analysis and evaluation, and publication of the study results: approx. 1 year

Official Title
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The Influence of a Proactive Palliative Care Intervention on Family Satisfaction and Biopsychosocial Problem-related Distress of Patients in a Surgical Intensive Care Unit: A Prospective Single-center Interventional Study

Conditions
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Palliative Care

Intervention / Treatment
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* Other: Proactive Palliative Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: need for intensive care for more than 3 days and at least one of the following trigger criteria: known advanced cancer severe cognitive impairment or dementia multi-organ failure Exclusion Criteria: Patients who already receive palliative care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective before-and after interventional study including 100 patients who receive usual intensive care followed by an interventional part with 100 patients who receive additional palliative care consultations
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group<br>One hundred patients of a control group will receive standard intensive care treatment (Usual Care Group). | |
| Other: Proactive Palliative Care<br>One hundred patients will additionally be offered a palliative care Intervention (Proactive Palliative Care Group). | Other: Proactive Palliative Care<br>* In the intervention part of the study, enrolled patients will be offered a set of different palliative care interventions, including symptom management, advance care planning, palliative physiotherapy, social and spiritual support, communication with patients and caregivers, in addition to standard intensive care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| family satisfaction in a surgical intensive care unit using a standardized questionnaire (FS-ICU). | To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs on family satisfaction in a surgical intensive care unit using a standardized questionnaire (FS-ICU). | after discharge from ICU, up to 1 year after enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' biopsychosocial problem-related distress after intensive care treatment measured with the NCCN distress thermometer | To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on patients' self-reported distress, measured with the NCCN distress thermometer | 60 days +/- 7 days after enrolment | 
| Intensive care length of stay | To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on ICU length of stay, measured as days in ICU. | up to 1 year after enrolment | 
| Duration of hospitalization | To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on hospital length of stay, measured as days in hospital. | up to 1 year after enrolment | 
| 1-year Patient survival | To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on overall survival of patients. | up to 1 year after enrolment | 
| Organ replacement therapy | To evaluate organ dysfunction and duration of replacement therapy, measured as days of mechanical ventilation and/or days of ECMO and/or days of hemofiltration, if applicable | up to 1 year after enrolment | 
| Functional assessment after 1 year | To evaluate functionality with regard to activities of daily living (Barthel Index) | up to 1 year after enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative care, surgical intensive care, family satisfaction, ICU decision-making, end-of-life care