Locally Advanced CancerSST2017NCT04143230
Identification of In-hospital Patients in Need of Palliative Care Using a New Simplified Screening Tool
A study testing Screening for PC by means of two different screening tools in people with Locally Advanced Cancer and Metastatic Cancer, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Cancer, Metastatic Cancer, Chronic Respiratory Failure
- What is being tested?
- Screening for PC by means of two different screening tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2017to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not able to be administered the screening tool
- major psychiatric disorders
- informed consent refusal
Trial locations and contacts
1 site in 1 country.
Italy1 site
Pain Management and Palliative Care, Department of Anesthesia, Intensive Care and Emergency, Molinette Hospital, University of Turin
Turin, 10126
About this study
Official title: Accuracy of a New Simplified Screening Tool in Identifying the In-hospital Patients in Need of Palliative Care
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.
Read more
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.
Read the 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.
- Conditions
- Locally Advanced Cancer, Metastatic Cancer, Chronic Respiratory Failure, Chronic Heart Failure, Chronic Liver Failure, Chronic Renal Failure
- Being tested
- Screening for PC by means of two different screening tools
- 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
- Medical subject headings
- Neoplasm Metastasis, End Stage Liver Disease, Kidney Failure, Chronic, Death, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for PC by means of two different screening toolsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Screening for PC by means of two different screening tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
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.
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year
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)
Measured: Through study completion, an average of 1 year
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).
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start23 May 2017
- Primary completion22 May 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Cotogni, A.O.U. Città della Salute e della Scienza
- Investigators
- Paolo Cotogni, MD, MSc, Principal investigator, Pain Manage&Palliative Care Dept Anesthesia Molinette University Hospital Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143230
- Sponsor's protocol ID
- 0014892
- Acronym
- SST2017
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28094484Au 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.
PubMed 16476873Kahn 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.
PubMed 20530778Jassal 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.
PubMed 19965545Glare 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.
PubMed 25392521Cotogni 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.
PubMed 28477288
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of a New Simplified Screening Tool in Identifying the In-hospital Patients in Need of Palliative Care
- ClinicalTrials.gov ID
- NCT04143230
- Acronym / sponsor ID
- SST2017 / 0014892
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Extended Screening Tool (EST) | Active comparator | Other: Screening for PC by means of two different screening toolsThe 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. |
| Simplified Screening Tool (SST) | Experimental | Other: Screening for PC by means of two different screening toolsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- not able to be administered the screening tool
- major psychiatric disorders
- informed consent refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for PC by means of two different screening toolsScreening 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. | Other | Extended Screening Tool (EST), Simplified Screening Tool (SST) |
Primary outcome
Accuracy of the Simplified Screening Tool (SST) with respect to the SIAARTI/NCCN screening tool (EST)
Time frame: Through study completion, an average of 1 year
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.
6 secondary outcomes
Accuracy of Surprise Question (SQ)
Time frame: Through study completion, an average of 1 year
Symptom control in palliative care patients
Time frame: Through study completion, an average of 1 year
Intensity of symptoms in patients admitted in an acute palliative care unit
Time frame: Through study completion, an average of 1 year
Survival of patients in need of palliative care assessment
Time frame: Through study completion, an average of 1 year
Discharge and unplanned hospital readmissions of patients in need of palliative care assessment
Time frame: Through study completion, an average of 1 year
Clinical characteristics and outcomes of palliative care patients referred to an acute palliative care unit
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Background: PubMed 28094484Cotogni 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.
- Background: PubMed 16476873Au 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.
- Background: PubMed 20530778Kahn 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.
- Background: PubMed 19965545Jassal 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.
- Background: PubMed 25392521Glare 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.
- Background: PubMed 28477288Cotogni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Cotogni, MD, MSc principal investigator
Pain Manage&Palliative Care Dept Anesthesia Molinette University Hospital Turin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for PC by means of two different screening tools in people with Locally Advanced Cancer and Metastatic Cancer, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the Simplified Screening Tool (SST) with respect to the SIAARTI/NCCN screening tool (EST) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04143230, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.