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

Palliative Care Clinical Trial

— EMPOWER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03906747
• Other study ID #: HSRG-EoL17Jun001
• Status: Active, not recruiting
• Start date: January 18, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cost Effectiveness
• Death
• Emergencies
• Emergency Department
• Palliative Care

Intervention

Other:
• Interviews, questionnaire and focused group discussions
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.
• Review of medical records
Electronic medical records will be reviewed to collect the following data: Proportion of patients who fits criteria of EOL who died within 48 hours; Proportion of patients on EOL pathway who have documentation that patient and/or family are given opportunities to discuss an individualised care plan; Proportion of patients on EOL pathway who have documentation of an individualised care plan that is followed; Proportion of patients on EOL pathway who have symptoms who are prescribed with medicines with individualised indications for use, dosage and route of administration

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore
Singapore	Khoo Teck Puat Hospital	Singapore
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Singapore Clinical Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Proportion of patients in EOL pathway who have documentation of an individualised care plan, and symptoms who are prescribed with appropriate medicine	Proportion of patients in EOL pathway who have documentation of an individualised care plan, and symptoms who are prescribed with appropriate medicine	26 months