Identification of In-hospital Patients in Need of Palliative Care Using a New Simplified Screening Tool
NCT ID: NCT04143230
Last Updated: 2019-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
660 participants
INTERVENTIONAL
2017-05-23
2019-10-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Extended Screening Tool (EST)
The SIAARTI/NCCN (EST) screening tool is, in fact, an instrument validated by many scientific societies, but it is very articulated and its compilation is too much time-consuming.
Screening for PC by means of two different screening tools
Screening of chronically ill patients admitted to an Internal Medicine Unit from the Emergency Department, for palliative care need, using of both the SIAARTI/NCCN screening tool (EST), and the Simplified Screening Tool (SST), derived from the first instrument.
Simplified Screening Tool (SST)
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.
Screening for PC by means of two different screening tools
Screening of chronically ill patients admitted to an Internal Medicine Unit from the Emergency Department, for palliative care need, using of both the SIAARTI/NCCN screening tool (EST), and the Simplified Screening Tool (SST), derived from the first instrument.
Interventions
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Screening for PC by means of two different screening tools
Screening of chronically ill patients admitted to an Internal Medicine Unit from the Emergency Department, for palliative care need, using of both the SIAARTI/NCCN screening tool (EST), and the Simplified Screening Tool (SST), derived from the first instrument.
Eligibility Criteria
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Inclusion Criteria
* 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
* major psychiatric disorders
* informed consent refusal
18 Years
ALL
No
Sponsors
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A.O.U. Città della Salute e della Scienza
OTHER
Responsible Party
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Paolo Cotogni
Head of Acute Palliative Care Unit and Palliative Care Team
Principal Investigators
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Paolo Cotogni, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Pain Manage&Palliative Care Dept Anesthesia Molinette University Hospital Turin
Locations
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Pain Management and Palliative Care, Department of Anesthesia, Intensive Care and Emergency, Molinette Hospital, University of Turin
Turin, , Italy
Countries
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References
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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.
Au DH, Udris EM, Fihn SD, McDonell MB, Curtis JR. Differences in health care utilization at the end of life among patients with chronic obstructive pulmonary disease and patients with lung cancer. Arch Intern Med. 2006 Feb 13;166(3):326-31. doi: 10.1001/archinte.166.3.326.
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.
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.
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.
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.
Other Identifiers
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0014892
Identifier Type: -
Identifier Source: org_study_id
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