Metastatic Cancer Clinical Trial
— SST2017Official title:
Accuracy of a New Simplified Screening Tool in Identifying the In-hospital Patients in Need of Palliative Care
NCT number | NCT04143230 |
Other study ID # | 0014892 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 23, 2017 |
Est. completion date | October 15, 2019 |
Verified date | October 2019 |
Source | Azienda Ospedaliera Città della Salute e della Scienza di Torino |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 660 |
Est. completion date | October 15, 2019 |
Est. primary completion date | May 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Pain Management and Palliative Care, Department of Anesthesia, Intensive Care and Emergency, Molinette Hospital, University of Turin | Turin |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Città della Salute e della Scienza di Torino |
Italy,
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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Accuracy of Surprise Question (SQ) | BACKGROUND: The surprise question (SQ), "Would the investigator be surprised if this patient died within the next year?" is effective in identifying the end-stage disease patients and therefore potentially unmet palliative care needs. The SG is one of the criteria assessed by screening tools to identify people in need of palliative care assessment. 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, underwent an evaluation of life expectancy using the Surprise Question (SQ). The outcome of this study is to evaluate the accuracy of SQ in identifying palliative care patients in their last year of life. |
Through study completion, an average of 1 year | |
Secondary | Symptom control in palliative care patients | BACKGROUND: Good symptom control is important for delivering effective palliative care METHODS: Patients with a diagnosis of chronic heart, lung, liver, and kidney failures, or advanced cancer, hospitalized after an ED visit, fully according to the screening tool score, in an acute palliative care unit due to uncontrolled symptoms OUTCOME MEASURE: Measurements will be aggregated to arrive at a comparison between admission and discharge times of: frequency (n,%) of following symptoms: pain, activity, nausea, depression, anxiety, drowsiness, appetite, sense of well-being and shortness of breath frequency (n,%) of use of pain killer, interventional procedures, palliative sedation |
Through study completion, an average of 1 year | |
Secondary | Intensity of symptoms in patients admitted in an acute palliative care unit | BACKGROUND: Good symptom control is important for delivering effective palliative care METHODS: Patients with a diagnosis of chronic heart, lung, liver, and kidney failures, or advanced cancer, hospitalized after an ED visit, fully according to the screening tool score, in an acute palliative care unit due to uncontrolled symptoms OUTCOME MEASURE: Measurements will be aggregated to arrive at a comparison between admission and discharge times of the intensity of symptoms using the Edmonton Symptom Assessment System, that consists of nine verbal numerical scales (0 as minimum value/better outcome; 10 as maximum value/ worse outcome) | Through study completion, an average of 1 year | |
Secondary | Survival of patients in need of palliative care assessment | BACKGROUND: Acute palliative care units (APCU) are new programs aimed at improving palliative care in hospitalized patients. Although most deaths in palliative care patients with end-stage diseases are expected, no data are available on survival. METHODS: Eligible patients with a known diagnosis of chronic heart, lung, liver, and kidney failures, or advanced cancer, hospitalized after an ED visit, fully according to the screening tool score in an APCU, due to uncontrolled symptoms. OUTCOME MEASURE DESCRIPTION: The aim of this study is to evaluate the survival time (day, months, years) from APCU admission to death for any cause (overall survival). |
Through study completion, an average of 1 year | |
Secondary | Discharge and unplanned hospital readmissions of patients in need of palliative care assessment | BACKGROUND: Discharge planning represents one of the most important and complex decisions for patients admitted to an acute palliative care unit (APCU). METHODS: Eligible patients with a known diagnosis of chronic heart, lung, liver, and kidney failures, or advanced cancer, hospitalized after an ED visit, fully according to the screening tool score, in an APCU. OUTCOME MEASURE DESCRIPTION: This study is to evaluate: the frequency of discharge at home and to hospice care the frequency of unplanned hospital readmissions of palliative care patients discharged from our APCU. |
Through study completion, an average of 1 year | |
Secondary | Clinical characteristics and outcomes of palliative care patients referred to an acute palliative care unit | BACKGROUND: Acute palliative care units (APCU) admit patients for symptom control, the transition to palliative care programs (home or hospice care), or end-of-life care. METHODS: Patients with a known diagnosis of chronic heart, lung, liver, and kidney failures, or advanced cancer, hospitalized after an ED visit, fully according to the screening tool score, in an APCU. OUTCOME MEASURE: multiple measurements will be aggregated to arrive at one detailed description of: frequency (n,%) of following symptoms: pain, activity, nausea, depression, anxiety, drowsiness, appetite, sense of well-being and shortness of breath frequency (n,%) of discharge at home and to hospice care |
Through study completion, an average of 1 year |
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