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

Palliative Care Clinical Trial

— PALL-ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03287323
• Other study ID #: 837.108.17 (10942)
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2017
• Last updated: September 15, 2017
• Start date: June 19, 2017
• Est. completion date: July 2021

Study information

• Verified date: September 2017
• Source: Johannes Gutenberg University Mainz
• Contact: Rita Laufenberg-Feldmann, M.D.
• Phone: +49 (0) 6131 17
• Email: rita.Laufenberg[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2021
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Palliative Care

Intervention

Other:
• Proactive Palliative Care
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.

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Braus N, Campbell TC, Kwekkeboom KL, Ferguson S, Harvey C, Krupp AE, Lohmeier T, Repplinger MD, Westergaard RP, Jacobs EA, Roberts KF, Ehlenbach WJ. Prospective study of a proactive palliative care rounding intervention in a medical ICU. Intensive Care Me — View Citation

Heyland DK, Tranmer JE; Kingston General Hospital ICU Research Working Group. Measuring family satisfaction with care in the intensive care unit: the development of a questionnaire and preliminary results. J Crit Care. 2001 Dec;16(4):142-9. — View Citation

Hua M, Wunsch H. Integrating palliative care in the ICU. Curr Opin Crit Care. 2014 Dec;20(6):673-80. doi: 10.1097/MCC.0000000000000149. Review. — View Citation

Mosenthal AC, Weissman DE, Curtis JR, Hays RM, Lustbader DR, Mulkerin C, Puntillo KA, Ray DE, Bassett R, Boss RD, Brasel KJ, Campbell M, Nelson JE. Integrating palliative care in the surgical and trauma intensive care unit: a report from the Improving Pal — View Citation

Selecky PA, Eliasson CA, Hall RI, Schneider RF, Varkey B, McCaffree DR; American College of Chest Physicians. Palliative and end-of-life care for patients with cardiopulmonary diseases: American College of Chest Physicians position statement. Chest. 2005 — View Citation

Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med. 2007 Jan;35(1):271-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Functional assessment after 1 year	To evaluate functionality with regard to activities of daily living (Barthel Index)	up to 1 year after enrolment