Quality of the End of Life Care

May 18, 2016 updated by: National Guard Health Affairs

Quality of the End of Life Care for Adult Patients With Advanced Cancer in Saudi Arabia

End-of life care is one of the principle components of cancer care. Measurement of the quality of care provided for end-of-life cancer patients is an important issue. Recently there has been an increased emphasis on measuring and monitoring the quality of cancer care for the purpose of improving clinical practice. Despite increasing attention paid to end-of-life care in recent years, many studies have described difficulties in the final phase of life, including problems with access to hospice, inadequate symptom management, care giving burdens, care mismatched with patient preferences, and inappropriate resource use. Measuring quality of life is an important issue for monitoring clinical practice and improving outcome. Although patient assessment is the best quality measure, it is impractical to measure the quality of end-of-life care because of the difficulties of accurate prognostication for end-of-life and many patients are too ill to provide assessments. In contrast, several recent studies developed quality indicators (QIs) of palliative and end-of-life care, which assess the quality from existing sources such as administrative data or medical chart data.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Quality of care has been defined as the 'degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge'.The challenge remains, however, to define key indicators of quality of care, to link those indicators with health outcomes, and to establish reliable, valid, and timely measurements of the indicators.

The development of QIs is based on the assumption that there is available evidence or a consensus position that can be used to assess the quality of care provided. As many areas of health care interventions operate with a limited evidence base, it is often necessary to combine the existing evidence with consensus techniques; such techniques explore consensus among a group of experts to reach a final aggregate opinion, expert-based knowledge

A systematic review published in 2006 that reviewed literature and relevant websites from USA, Europe, Canada, and Australia concluded that there were limited tools to evaluate whether cancer patients receive effective supportive treatment. In response, the cancer-quality Assessing Symptoms Side Effects and Indicators of Supportive Treatment (ASSIST) measures were developed .These ninety two quality indicators (QIs) were developed for medical record abstraction using the RAND-UCLA QI development method; they cover assessment and treatment of pain and other symptoms as well as information and care planning. However there are a number of other indicators that can be studied these include intensive care unit (ICU) visit, Emergency (ER) visits and chemotherapy use close to death.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Abdul Aziz Medical City for National Guard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with advanced cancer defined as patients who are 18 years or older with stage IV or metastatic disease at the last month of their life.

Description

Inclusion Criteria:

  1. Documented confirmed cancer diagnosis.
  2. 18 year or older.
  3. Patients with advanced cancer (stage IV or with metastasis).
  4. Any hospital admission within the last 30 days.

Exclusion Criteria:

  1. Cancer patients admitted under care of other specialties other than oncology.
  2. Patients who had a major surgery within one month of death, which required admission for more than 1 day under general anesthesia.
  3. Patients who were following with other hospitals transferred and died within 3 days of admission.
  4. Cancer diagnosis was made only on death certificate with no prior cancer diagnosis.
  5. Patient died outside hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To measure the quality of care provided by oncology department to adult patients with advanced cancer in the last month of their life using The Cancer Quality-ASSIST QI (Assessing Symptoms Side Effects and Indicators of Supportive Treatment
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Guard Health Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C15/003/R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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