Clinical trial NCT04143230: Identification of In-hospital Patients in Need of Palliative Care Using a New Simplified Screening Tool
Official title: Accuracy of a New Simplified Screening Tool in Identifying the In-hospital Patients in Need of Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Locally Advanced Cancer
Metastatic Cancer
Chronic Respiratory Failure
Chronic Heart Failure
Chronic Liver Failure
Chronic Renal Failure
Keywords: palliative care
palliative care team
palliative care unit
screening tool
end of life
unplanned hospital admission
end-stage disease
cancer
survival
prognostic score
palliative sedation
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Eligible patients will be evaluated for the need of palliative care, randomly by means of the EST screening tool (ARM A) or by means of the Simplified Screening Tool (SST), (ARM B).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Every day many patients affected by chronic life-limiting illnesses are admitted into Internal Medicine wards, coming from the Emergency Department. Many studies suggest that providing palliative care to these patients may improve their end-of-life care while reducing costs by minimizing futile treatments and unwanted intensive care unit admissions. Consequently, there is a strong need for acute care hospitals to more vigorously identify patients entering the final phase of their lives as well as their specific care needs.

In a previous study the investigators screened for need of palliative care patients affected by progressive chronic diseases by means of a tool, based on the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care - SIAARTI - position paper reporting criteria for patients with end-stage chronic organ failures, and on the specific clinical indicators elaborated by the National Comprehensive Cancer Network (NCCN) for patients with locally advanced/metastatic cancer. In a further pilot study, the investigators compared the outcomes of PC patients depending on whether the palliative care team evaluated such patients only if requested by the physician staff or routinely, irrespectively of a specific request, finding a significant increase of discharges after the activation of an appropriate PC service or scheduled PC ambulatory visit.

In the present study the investigators enroll chronically ill patients admitted to an Internal Medicine Unit from the Emergency Department, to be screened for palliative care need, using the previously cited SIAARTI/NCCN screening tool (Extended Screening Tool - EST), or using a Simplified Screening Tool (SST), derived from the first instrument, which preliminary showed a superimposable efficacy. This latter tool has advantages related to much more shortness and therefore simplicity in the administration to a seriously ill patient and is much less time consuming, allowing the physician to use it routinely.

The aim of the study is to verify the accuracy of the SST in identifying chronically ill patients in need of a PC approach, in comparison to the SIAARTI/NCCN tool (EST). If the SST would show good accuracy, an easily manageable tool for the assessment of PC needs in chronically ill patients would be available for the daily routine.

Detailed description: Due to population aging and advances in medicine and public health, the prevalence of people affected by progressive, chronic, life-limiting diseases is increasing. Many studies documented that patients with progressive chronic diseases received care that was more aimed at the prolongation of life than palliation of symptoms during their last 6-12 months of life, as well as frequent hospitalizations. These data suggested that providing palliative care (PC) to these patients may improve their end-of-life care while reducing costs by minimizing futile treatments and unwanted ICU care.

Consequently, there is a strong need for acute care hospitals to more vigorously identify patients entering the final phase of their lives as well as their specific care needs.

Historically, Hospice and PC services have focused on the needs of cancer patients. However, the majority of patients needing PC worldwide suffer from life-limiting non-cancer illnesses, like cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal failure, cirrhosis of the liver, Alzheimer's and other dementias, multiple sclerosis, Parkinson's disease, HIV/AIDS, rheumatoid arthritis, and diabetes. The main illnesses requiring PC are cardiovascular diseases (38%), cancer (34%), and COPD (10%).

In order to correctly identify such patients, adequate screening tools are needed.

In a previous study, the investigators employed for this aim a screening tool derived from the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care (SIAARTI) position paper based on expert panel opinions reporting criteria to identify patients with end-stage chronic organ failures. For cancer patients, the screening was done according to specific clinical indicators elaborated by the National Comprehensive Cancer Network (NCCN). A Simplified Screening Tool was also created, in order to make available an easier instrument for the same aim.

The SIAARTI/NCCN screening tool (Extended Screening Tool - EST) is, in fact, an instrument validated by many scientific societies, but it is very articulated and its compilation is too much time-consuming. The Simplified Screening Tool (SST) has been created through a statistical process in order to include all the critical variables, with the advantage of being shorter and therefore easier to administer in a routinely use.

The aim of the current study is to demonstrate that the SST has accuracy comparable to that of the SIAARTI/NCCN tool in identifying chronically ill patients in need of a PC approach, thus making available an easily manageable tool for the assessment of PC needs in chronically ill patients.

In order to do this, every enrolled patient will be administered both the SST and the SIAARTI/NCCN tool, in a randomized sequence.

After completion of the enrollment and data collection, an appropriate statistical methodology will be employed for the comparison between the established SIAARTI/NCCN tool and the SST.

Eligibility criteria: Inclusion Criteria:

Patients admitted to Molinette Hospital (A.O.U. "Città della Salute e della Scienza"), affected by:

* locally advanced/metastatic cancer not suitable to antineoplastic therapy
* locally advanced/metastatic cancer suitable for palliative antineoplastic therapy
* locally advanced/metastatic cancer with uncontrolled symptoms
* end-stage heart failure
* end-stage respiratory failure
* end-stage liver failure
* end-stage renal failure

Exclusion Criteria:

* not able to be administered the screening tool
* major psychiatric disorders
* informed consent refusal

Primary outcomes:
measure: Accuracy of the Simplified Screening Tool (SST) with respect to the SIAARTI/NCCN screening tool (EST)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Accuracy of Surprise Question (SQ)
timeFrame: Through study completion, an average of 1 year
measure: Symptom control in palliative care patients
timeFrame: Through study completion, an average of 1 year
measure: Intensity of symptoms in patients admitted in an acute palliative care unit
timeFrame: Through study completion, an average of 1 year
measure: Survival of patients in need of palliative care assessment
timeFrame: Through study completion, an average of 1 year
measure: Discharge and unplanned hospital readmissions of patients in need of palliative care assessment
timeFrame: Through study completion, an average of 1 year
measure: Clinical characteristics and outcomes of palliative care patients referred to an acute palliative care unit
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Pain Management and Palliative Care, Department of Anesthesia, Intensive Care and Emergency, Molinette Hospital, University of Turin
Study officials:
affiliation: Pain Manage&Palliative Care Dept Anesthesia Molinette University Hospital Turin
name: Paolo Cotogni, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cotogni P, DE Luca A, Evangelista A, Filippini C, Gili R, Scarmozzino A, Ciccone G, Brazzi L. A simplified screening tool to identify seriously ill patients in the Emergency Department for referral to a palliative care team. Minerva Anestesiol. 2017 May;83(5):474-484. doi: 10.23736/S0375-9393.16.11703-1. Epub 2017 Jan 17.
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citation: Kahn JM, Benson NM, Appleby D, Carson SS, Iwashyna TJ. Long-term acute care hospital utilization after critical illness. JAMA. 2010 Jun 9;303(22):2253-9. doi: 10.1001/jama.2010.761.
citation: Jassal SV, Watson D. Dialysis in late life: benefit or burden. Clin J Am Soc Nephrol. 2009 Dec;4(12):2008-12. doi: 10.2215/CJN.04610709. Epub 2009 Nov 5.
citation: Glare PA, Chow K. Validation of a Simple Screening Tool for Identifying Unmet Palliative Care Needs in Patients With Cancer. J Oncol Pract. 2015 Jan;11(1):e81-6. doi: 10.1200/JOP.2014.001487. Epub 2014 Nov 12.
citation: Cotogni P, De Luca A, Saini A, Brazzi L. Unplanned hospital admissions of palliative care patients: a great challenge for internal and emergency medicine physicians. Intern Emerg Med. 2017 Aug;12(5):569-571. doi: 10.1007/s11739-017-1671-3. Epub 2017 May 5. No abstract available.