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NCT Number: NCT04143230

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

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.

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Key information

Conditions

Locally Advanced Cancer Chronic Disease Chronic Heart Failure Chronic Liver Failure Chronic Renal Failure Chronic Respiratory Failure Death Digestive System Diseases Disease Attributes End Stage Liver Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hepatic Insufficiency Kidney Diseases Kidney Failure, Chronic Liver Diseases Liver Failure Male Urogenital Diseases Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Turin, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Accuracy of Surprise Question (SQ)

    Time frame: Through study completion, an average of 1 year

    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.

  2. Symptom control in palliative care patients

    Time frame: Through study completion, an average of 1 year

    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

  3. Intensity of symptoms in patients admitted in an acute palliative care unit

    Time frame: Through study completion, an average of 1 year

    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)

  4. Survival of patients in need of palliative care assessment

    Time frame: Through study completion, an average of 1 year

    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).

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

    Time frame: Through study completion, an average of 1 year

    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.

  6. 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

    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

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Official study title

Accuracy of a New Simplified Screening Tool in Identifying the In-hospital Patients in Need of Palliative Care

Acronym: SST2017

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2019
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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