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

Johannes Gutenberg University (JGU)

Status: Unknown

Conditions: Palliative Care

Treatments: Other: Proactive Palliative Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03287323

837.108.17 (10942)

Details and patient eligibility

About

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.

Full description

The project consists of different consecutive parts:

1. 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

2. 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

   1. 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.

   2. 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.

3. Termination of study including data analysis and evaluation, and publication of the study results: approx. 1 year

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• need for intensive care for more than 3 days and at least one of the following trigger criteria:

  1. known advanced cancer
  2. severe cognitive impairment or dementia
  3. multi-organ failure

Exclusion criteria

• Patients who already receive palliative care

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Usual Care Group

No Intervention group

Description:

One hundred patients of a control group will receive standard intensive care treatment (Usual Care Group).

Proactive Palliative Care

Other group

Description:

One hundred patients will additionally be offered a palliative care Intervention (Proactive Palliative Care Group).

Treatment:

Other: Proactive Palliative Care