NCT03906747

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 13, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

February 25, 2019

Last Update Submit

April 12, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Mortality rate within 48 hours of hospital admission

    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

    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

    Level of satisfaction of with the overall quality of end of life care provision by doctors at ED

    26 months

Secondary Outcomes (1)

  • Proportion of patients in EOL pathway who have documentation of an individualised care plan, and symptoms who are prescribed with appropriate medicine

    26 months

Study Arms (3)

Patients

Patients at their end-of-life (EOL) phase attending the emergency department

Other: Review of medical records

Family members and next-of-kin of (EOL) patients

Family members and next-of-kin of EOL patients in the emergency department

Other: Interviews, questionnaire and focused group discussions

Healthcare workers

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

Other: Interviews, questionnaire and focused group discussions

Interventions

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.

Family members and next-of-kin of (EOL) patientsHealthcare workers

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

Patients

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National University Hospital

Singapore, 119074, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

Related Publications (2)

  • Chua MT, Sen Kuan W, Zheng CQ, Tiah L, Kumar R, Wong YKY, Lin J, Liang S, Mayland CR, Shi L, Ibrahim I, Pal RY. Validation of "Care of the Dying Evaluation" in Emergency Medicine (CODE-EM): pilot phase of end-of-life management protocol offered within emergency room (EMPOWER) study. Ann Palliat Med. 2021 Jun;10(6):6145-6155. doi: 10.21037/apm-21-380. Epub 2021 May 25.

  • Yash Pal R, Kuan WS, Tiah L, Kumar R, Wong YKY, Shi L, Zheng CQ, Lin J, Liang S, Segara UC, Yong WC, Chan NGC, Chua MT, Ibrahim I. End-of-life management protocol offered within emergency room (EMPOWER): study protocol for a multicentre study. BMJ Open. 2020 Apr 28;10(4):e036598. doi: 10.1136/bmjopen-2019-036598.

MeSH Terms

Conditions

Emergencies

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

April 8, 2019

Study Start

January 18, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

April 13, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations