Identification of In-hospital Patients in Need of Palliative Care Using a New Simplified Screening Tool

NCT04143230 | Completed

• 1 other identifier: 0014892
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Accuracy of the Simplified Screening Tool (SST) with respect to the SIAARTI/NCCN screening tool (EST)

  BACKGROUND: The aims of this study were to evaluate the feasibility of an Emergency Department (ED)-initiated screening to identify seriously ill patients in need of palliative care (PC) and to develop a simplified screening tool (SST). METHODS: Eligible patients with a known diagnosis of chronic heart, lung, liver, and kidney failures, or advanced cancer, awaiting to be hospitalized after an ED visit, were assessed with both screening tools (ie, EST and SST). The outcome of this study is to evaluate the accuracy of the SST in identifying chronically ill patients in need of a palliative care assessment in the hospital setting.

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Accuracy of Surprise Question (SQ)

  Through study completion, an average of 1 year

• Symptom control in palliative care patients

  Through study completion, an average of 1 year

• Intensity of symptoms in patients admitted in an acute palliative care unit

  Through study completion, an average of 1 year

• Survival of patients in need of palliative care assessment

  Through study completion, an average of 1 year

• Discharge and unplanned hospital readmissions of patients in need of palliative care assessment

  Through study completion, an average of 1 year

Study Arms (2)

Extended Screening Tool (EST)

ACTIVE COMPARATOR

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.

Other: Screening for PC by means of two different screening tools

Simplified Screening Tool (SST)

EXPERIMENTAL

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.

Other: Screening for PC by means of two different screening tools

Interventions

Screening for PC by means of two different screening tools OTHER

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.

Extended Screening Tool (EST); Simplified Screening Tool (SST)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

Pain Management and Palliative Care, Department of Anesthesia, Intensive Care and Emergency, Molinette Hospital, University of Turin

Turin, 10126, Italy

Location

Related Publications (6)

• 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.

  PMID: 28094484 BACKGROUND

• 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.

  PMID: 16476873 BACKGROUND

• 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.

  PMID: 20530778 BACKGROUND

• 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.

  PMID: 19965545 BACKGROUND

• 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.

  PMID: 25392521 BACKGROUND

• 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.

  PMID: 28477288 BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis; End Stage Liver Disease; Kidney Failure, Chronic; Death; Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Paolo Cotogni, MD, MSc

  Pain Manage&Palliative Care Dept Anesthesia Molinette University Hospital Turin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The Principal Investigator provided close envelops containing the SIAARTI/NCCN screening tool or the Simplified Screening Tool. The screening tool was inserted in the envelop according with a randomization list. The sub-investigator who wold examine the patient had to take the close envelope marked with the corresponding progressive number of patient enrolled, without possibility of choose the tool.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Acute Palliative Care Unit and Palliative Care Team

Model Details: 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).

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 29, 2019
• Study Start: May 23, 2017
• Primary Completion: May 22, 2019
• Study Completion: October 15, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)