Increasing the Uptake of Advanced Directives in SingHealth Polyclinics

September 23, 2019 updated by: Xu Cunzhi, SingHealth Polyclinics

Assessing the Effectiveness of Different Interventions in Increasing the Completion Rates of the Advanced Medical Directive in the Polyclinic Setting in Singapore - A Randomized Controlled Trial

An Advanced Medical Directive (AMD) is a legal document in Singapore that allows one to inform their medical practitioner that they do not want any life-sustaining treatment should they become unconscious and terminally ill where death is imminent. Despite the AMD act being passed in Singapore Parliament in 1996, uptake remains low among the population. Several intervention studies have shown that education and communication can be effective in promoting end-of-life discussion and planning. In this study, we aim to compare the effectiveness of counselling sessions together with pamphlets, versus pamphlets alone, versus current care, in increasing the completion rates of the AMD in the Singapore Polyclinic setting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

An Advanced Medical Directive (AMD) is a legal document in Singapore that allows one to inform their medical practitioner that they do not want any life-sustaining treatment should they become unconscious and terminally ill where death is imminent. It may be completed by any person, of sound mind, aged 21 years and above.The AMD Act was passed in the Singapore Parliament in May 1996.

A cross-sectional, community-based study surveyed 1200 selected households in Singapore. Only 37.9% of the sample population had heard of the AMD prior to the study, though when approached, 60.6% were willing to sign an AMD. As of 2017, less than 25,000 people (0.45%) in Singapore have opted to sign an AMD.

Past studies have shown that end of life discussions reduce stress, anxiety, and depression in surviving relatives. A local study in 2010 revealed a 33% patient-surrogate discrepancy in end-of-life decision making.

There are a lack of intervention studies regarding AMD in Singapore. In this study, we aim to compare the effectiveness of counselling sessions together with pamphlets, versus pamphlets alone, versus current care, in increasing the completion rates of the AMD in the Singapore Polyclinic setting.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
189

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 440080
        • Marine Parade Polyclinic
      • Singapore, Singapore, 469662
        • Bedok Polyclinic
      • Singapore, Singapore, 529203
        • Tampines Polyclinic
      • Singapore, Singapore, 168937
        • Outram Polyclinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 40
  • Patient who seeks medical consultation at Singhealth Polyclinics (Bedok, Marine Parade, Outram, Tampines)

Exclusion Criteria:

  • History of dementia
  • History of depression
  • Known diagnosis of terminal illness
  • Signed Advanced Medical Directive/Advanced Care Plan previously

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Active Comparator: Active Intervention
subjects will be given a pamphlet about the advanced medical directive, and a standardized face-to-face counselling session will be conducted with their healthcare provider
Behavioral: standardised face-to-face counselling session
the healthcare provider will conduct a standardised face-to-face counselling session guided with subjects guided by a check-list of topics to cover regarding the Advanced Medical Directive.
Behavioral: advanced medical directive pamphlet
A standardised pamphlet containing information about the Advanced Medical Directive produced by the Ministry of Health, Singapore.
Active Comparator: Passive Intervention
subjects will be given a pamphlet about the advanced medical directive
Behavioral: advanced medical directive pamphlet
A standardised pamphlet containing information about the Advanced Medical Directive produced by the Ministry of Health, Singapore.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of patients who completed the Advanced Medical Directive
Time Frame: 4 months
4 months
Number of patient who expressed interest to complete the Advanced Medical Directive
Time Frame: 4 months
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Barriers to completion of the Advanced Medical Directive
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SingHealth Polyclinics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lian Leng Low, MBBS, low.lian.leng@singhealth.com.sg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Polyclinics AMD Intervention

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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