End-of-Life Management Protocol Offered Within Emergency Room: a Multicentre Study (EMPOWER) (EMPOWER)

April 12, 2022 updated by: National University Hospital, Singapore

End-of-life (EOL) care has garnered increasing recognition and acceptance in the field of emergency medicine. Some emergency departments (EDs) in Singapore have instituted or plan to institute EOL care as part of the workflow. However, the EOL protocols are not standardised across all these EDs. The adherence to and quality of EOL care have not been formally measured in all institutions. Hence, gaps to improve the quality of care have yet to be determined.

The aims are to systematically measure the current quality of EOL care in three Singapore hospital EDs and identify the quality gaps; formulate interventions to address these gaps and implement the improved EOL care; and measure the improvement post-implementation. The investigators hypothesise that the current quality of EOL care in three EDs is suboptimal and the interventions planned will improve the quality of care provided.

The study team plans to conduct an interrupted time series study to detect whether the interventions have an effect significantly greater than any underlying trend over time. The quality of care indicators to be measured are timely identification of patients who require EOL care, adequacy of symptom control based on compliance to prescriptions, opportunities to discuss and develop an individualised care plan, perceived quality of care by healthcare providers and next-of-kin, and cost effectiveness. Planned interventions include refining the protocol with collaboration of content experts in palliative care, education and training of healthcare providers, and addressing specific gaps identified to improve cost effectiveness. The results of this study will form the standardisation and foundation for establishing the national benchmark for quality of EOL care in Singapore EDs.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

900

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

      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 529889
        • Changi General Hospital
      • Singapore, Singapore, 768828
        • Khoo Teck Puat Hospital

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

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients attending the emergency department at their end-of-life phase, relatives of such patients and healthcare workers involved with care

Description

Inclusion Criteria:

  • Actively dying patient or high likelihood of mortality within 48 hours
  • Family accepts that the goals of care are provision of comfort, symptom relief and respect of dignity
  • Patient is not a candidate for cardiopulmonary resuscitation, endotracheal intubation or transfer to the intensive care unit
  • Family members want to stay by patient's bedside
  • Any of the life-limiting conditions such as chronic frailty with poor functional state and limited reversibility (Karnofski Performance Scale <40%), chronic severe illness with poor prognosis, or other deteriorating conditions and at risk of dying with complications that are not reversible, as subject to the treating clinician's judgment

Exclusion Criteria:

  • Vulnerable population e.g. prisoners, pregnant women
  • Patients, relatives or staff who refused to participate
  • Patients who have been recruited, or had declined participation, in the previous ED attendance(s)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients at their end-of-life (EOL) phase attending the emergency department

Electronic medical records will be reviewed to collect the following data:

  1. Proportion of patients who fits criteria of EOL who died within 48 hours;
  2. Proportion of patients on EOL pathway who have documentation that patient and/or family are given opportunities to discuss an individualised care plan;
  3. Proportion of patients on EOL pathway who have documentation of an individualised care plan that is followed;
  4. Proportion of patients on EOL pathway who have symptoms who are prescribed with medicines with individualised indications for use, dosage and route of administration
Family members and next-of-kin of (EOL) patients
Family members and next-of-kin of EOL patients in the emergency department

To determine the effectiveness of the quality of care as perceived by relatives, we will perform a survey during the ED stay, with the next-of-kin to patients who was on the EOL pathway using a questionnaire developed for ED settings. The questionnaire will be administered by the research assistant face-to-face in the emergency department to assess the quality of care and the level of support provided to patients and their families in the last days of life.

We will also determine the level of staff's knowledge and perception of the EOL care using a locally-designed self-administered anonymous survey.

A focus group discussion (FGD) will be formed in each hospital to identify the gaps to the current EOL care by structured questionnaire. The group will also make recommendations to improve the quality of the EOL care. There will be separate FGD for: (i) healthcare professionals (ii) family members and (iii) general practitioners who will care for the patient if terminally discharged.

Healthcare workers
Comprised of doctors in the emergency department, nurses and general practitioners

To determine the effectiveness of the quality of care as perceived by relatives, we will perform a survey during the ED stay, with the next-of-kin to patients who was on the EOL pathway using a questionnaire developed for ED settings. The questionnaire will be administered by the research assistant face-to-face in the emergency department to assess the quality of care and the level of support provided to patients and their families in the last days of life.

We will also determine the level of staff's knowledge and perception of the EOL care using a locally-designed self-administered anonymous survey.

A focus group discussion (FGD) will be formed in each hospital to identify the gaps to the current EOL care by structured questionnaire. The group will also make recommendations to improve the quality of the EOL care. There will be separate FGD for: (i) healthcare professionals (ii) family members and (iii) general practitioners who will care for the patient if terminally discharged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate within 48 hours of hospital admission
Time Frame: 26 months
Proportion of patients who fits criteria of EOL who died within 48 hours (patient centred)
26 months
Satisfaction assessed by Care of the Dying Evaluation (CODE) questionnaire
Time Frame: 26 months
Proportion of next-of-kin who perceived that they were adequately supported (family centred)
26 months
Satisfaction of healthcare workers with care rendered assessed by a staff survey
Time Frame: 26 months
Level of satisfaction of with the overall quality of end of life care provision by doctors at ED
26 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients in EOL pathway who have documentation of an individualised care plan, and symptoms who are prescribed with appropriate medicine
Time Frame: 26 months
Proportion of patients in EOL pathway who have documentation of an individualised care plan, and symptoms who are prescribed with appropriate medicine
26 months

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

January 18, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSRG-EoL17Jun001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Palliative Care

Clinical Trials on Review of medical records

3
Subscribe