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Increasing the Uptake of Advanced Directives in SingHealth Polyclinics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499847
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Xu Cunzhi, SingHealth Polyclinics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Medical Directive, a Legal Document Signed in Advance to State Healthcare Preferences Behavioral: standardised face-to-face counselling session Behavioral: advanced medical directive pamphlet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

3-arm, randomised control trial

  1. Active Intervention group (n=65) Counselling provided Pamphlet given
  2. Passive Intervention group (n=65) Pamphlet given
  3. Control group (n=65) Neither counselling nor pamphlet given
Masking: Single (Outcomes Assessor)
Masking Description: subjects will be interviewed over the telephone 6 weeks after initial intervention by a blinded assessor to assess outcomes
Primary Purpose: Health Services Research
Official Title: 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
Actual Study Start Date : March 29, 2018
Actual Primary Completion Date : December 19, 2018
Actual Study Completion Date : December 19, 2018

Arm Intervention/treatment
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.

No Intervention: Control



Primary Outcome Measures :
  1. Number of patients who completed the Advanced Medical Directive [ Time Frame: 4 months ]
  2. Number of patient who expressed interest to complete the Advanced Medical Directive [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Barriers to completion of the Advanced Medical Directive [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499847


Locations
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Singapore
Outram Polyclinic
Singapore, Singapore, 168937
Marine Parade Polyclinic
Singapore, Singapore, 440080
Bedok Polyclinic
Singapore, Singapore, 469662
Tampines Polyclinic
Singapore, Singapore, 529203
Sponsors and Collaborators
SingHealth Polyclinics
Investigators
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Principal Investigator: Lian Leng Low, MBBS low.lian.leng@singhealth.com.sg

Additional Information:
Publications:

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Responsible Party: Xu Cunzhi, Family Medicine Resident, SingHealth Polyclinics
ClinicalTrials.gov Identifier: NCT03499847    
Other Study ID Numbers: Polyclinics AMD Intervention
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No