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

NCT03287323 | Unknown

• 1 other identifier: 837.108.17 (10942)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palliative Care

Keywords

palliative care; surgical intensive care; family satisfaction; ICU decision-making; end-of-life care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patients' biopsychosocial problem-related distress after intensive care treatment measured with the NCCN distress thermometer

  60 days +/- 7 days after enrolment

• Intensive care length of stay

  up to 1 year after enrolment

• Duration of hospitalization

  up to 1 year after enrolment

• 1-year Patient survival

  up to 1 year after enrolment

• Organ replacement therapy

  up to 1 year after enrolment

Study Arms (2)

Usual Care Group

NO INTERVENTION

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

Proactive Palliative Care

OTHER

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

Other: Proactive Palliative Care

Interventions

Proactive Palliative Care OTHER

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.

Proactive Palliative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who already receive palliative care

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany

Mainz, 55131, Germany

RECRUITING

Related Publications (6)

• 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.

  PMID: 25233330 RESULT

• 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. doi: 10.1053/jcrc.2001.30163.

  PMID: 11815899 RESULT

• 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. doi: 10.1097/01.CCM.0000251122.15053.50.

  PMID: 17133189 RESULT

• 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 Nov;128(5):3599-610. doi: 10.1378/chest.128.5.3599.

  PMID: 16304319 RESULT

• 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 Palliative Care in the Intensive Care Unit (IPAL-ICU) Project Advisory Board and the Center to Advance Palliative Care. Crit Care Med. 2012 Apr;40(4):1199-206. doi: 10.1097/CCM.0b013e31823bc8e7.

  PMID: 22080644 RESULT

• 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 Med. 2016 Jan;42(1):54-62. doi: 10.1007/s00134-015-4098-1. Epub 2015 Nov 10.

  PMID: 26556622 RESULT

Central Study Contacts

Rita Laufenberg-Feldmann, M.D.

CONTACT

+49 (0) 6131 17; rita.Laufenberg@unimedizin-mainz.de

Marion Ferner, M.D.

CONTACT

+49 (0) 6131 17; Marion.Ferner@unimedizin-mainz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiologist, Head of Clinical Trial Unit

Model Details: 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

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 19, 2017
• Study Start: June 19, 2017
• Primary Completion: April 1, 2020
• Study Completion: July 1, 2021
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)