Clinical trial NCT03906747: End-of-Life Management Protocol Offered Within Emergency Room: a Multicentre Study (EMPOWER)
Official title: End-of-Life Management Protocol Offered Within Emergency Room: a Multicentre Study (EMPOWER)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Palliative Care
Emergency Department
Cost Effectiveness
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Singapore Clinical Research Institute
First posted: 2019-04-08
Enrollment: 900
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mortality rate within 48 hours of hospital admission
timeFrame: 26 months
measure: Satisfaction assessed by Care of the Dying Evaluation (CODE) questionnaire
timeFrame: 26 months
measure: Satisfaction of healthcare workers with care rendered assessed by a staff survey
timeFrame: 26 months
Secondary outcomes:
measure: Proportion of patients in EOL pathway who have documentation of an individualised care plan, and symptoms who are prescribed with appropriate medicine
timeFrame: 26 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
Study officials:
References:
citation: 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.
citation: 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.