Clinical trial NCT03287323: Proactive Palliative Care Intervention in a Surgical ICU: Influence on Family Satisfaction and Patient Distress
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palliative Care
Keywords: palliative care
surgical intensive care
family satisfaction
ICU decision-making
end-of-life care
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: family satisfaction in a surgical intensive care unit using a standardized questionnaire (FS-ICU).
timeFrame: after discharge from ICU, up to 1 year after enrolment
Secondary outcomes:
measure: Patients' biopsychosocial problem-related distress after intensive care treatment measured with the NCCN distress thermometer
timeFrame: 60 days +/- 7 days after enrolment
measure: Intensive care length of stay
timeFrame: up to 1 year after enrolment
measure: Duration of hospitalization
timeFrame: up to 1 year after enrolment
measure: 1-year Patient survival
timeFrame: up to 1 year after enrolment
measure: Organ replacement therapy
timeFrame: up to 1 year after enrolment
measure: Functional assessment after 1 year
timeFrame: up to 1 year after enrolment
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany
Study officials:
References:
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.
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. doi: 10.1053/jcrc.2001.30163.
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. doi: 10.1097/01.CCM.0000251122.15053.50.
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 Nov;128(5):3599-610. doi: 10.1378/chest.128.5.3599.
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 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.
citation: 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.