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

NCT ID: NCT03906747

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-18
• Study Completion Date: 2022-12-31

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.

Conditions

Palliative Care; Emergency Department; Cost Effectiveness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

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

Review of medical records

Intervention Type: OTHER

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

Interviews, questionnaire and focused group discussions

Intervention Type: OTHER

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

Interviews, questionnaire and focused group discussions

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Review of medical records

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore Clinical Research Institute

OTHER

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital

Singapore, , Singapore

Changi General Hospital

Singapore, , Singapore

Khoo Teck Puat Hospital

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 34118856 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32350018 (View on PubMed)

Other Identifiers

HSRG-EoL17Jun001

Identifier Type: -

Identifier Source: org_study_id