Palliative CareEMPOWERNCT03906747
End-of-Life Management Protocol Offered Within Emergency Room: a Multicentre Study (EMPOWER)
An observational study of Palliative Care and Emergency Department, run by National University Hospital, Singapore at 3 sites in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Palliative Care, Emergency Department, Cost Effectiveness
- What is being tested?
- Interviews, questionnaire and focused group discussions and Review of medical records
- How many people
- 900 participants
- Where
- 3 sitesSingapore
- Study dates
- 18 Jan 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending the emergency department at their end-of-life phase, relatives of such patients and healthcare workers involved with care
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
National University Hospital
Singapore, 119074
Changi General Hospital
Singapore, 529889
Khoo Teck Puat Hospital
Singapore, 768828
About this study
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.
- Conditions
- Palliative Care, Emergency Department, Cost Effectiveness
- Being tested
- Interviews, questionnaire and focused group discussions, Review of medical records
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews, questionnaire and focused group discussionsOther
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 recordsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients at their end-of-life (EOL) phase attending the emergency department Receives: 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 Receives: Other: Interviews, questionnaire and focused group discussions | |
| Healthcare workers | Comprised of doctors in the emergency department, nurses and general practitioners Receives: Other: Interviews, questionnaire and focused group discussions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate within 48 hours of hospital admission
Proportion of patients who fits criteria of EOL who died within 48 hours (patient centred)
Measured: 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)
Measured: 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
Measured: 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
Proportion of patients in EOL pathway who have documentation of an individualised care plan, and symptoms who are prescribed with appropriate medicine
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start18 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Clinical Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906747
- Sponsor's protocol ID
- HSRG-EoL17Jun001
- Acronym
- EMPOWER
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2019
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34118856Yash 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.
PubMed 32350018
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-of-Life Management Protocol Offered Within Emergency Room: a Multicentre Study (EMPOWER)
- ClinicalTrials.gov ID
- NCT03906747
- Acronym / sponsor ID
- EMPOWER / HSRG-EoL17Jun001
- Conditions
- Palliative Care, Emergency Department, Cost Effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Singapore Clinical Research Institute
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Review of medical recordsPatients at their end-of-life (EOL) phase attending the emergency department |
| Family members and next-of-kin of (EOL) patients | – | Other: Interviews, questionnaire and focused group discussionsFamily members and next-of-kin of EOL patients in the emergency department |
| Healthcare workers | – | Other: Interviews, questionnaire and focused group discussionsComprised of doctors in the emergency department, nurses and general practitioners |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the emergency department at their end-of-life phase, relatives of such patients and healthcare workers involved with care
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interviews, questionnaire and focused group discussionsTo 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. | Other | Family members and next-of-kin of (EOL) patients, Healthcare workers |
| Review of medical recordsElectronic 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 | Other | Patients |
Primary outcome
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)
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)
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 34118856Chua 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.
- Derived from this study: PubMed 32350018Yash 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care and Emergency Department, run by National University Hospital, Singapore at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate within 48 hours of hospital admission (time frame: 26 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906747, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.