Condition category
Not Applicable
Date applied
10/11/2017
Date assigned
21/11/2017
Last edited
20/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Advance care planning is the process of communication in which patients with advanced progressive disease and their healthcare providers establish their future goal of medical care during end-of-life (EOL). Studies have shown that video decision aids are effective at promoting end-of-life care decision making. However, little is known about their feasibility in Asian cultures. A local video decision aid has been developed to fit the local context. The video was developed in a balanced manner by showing the positive and negative features of different goals of medical care. Visual images illustrating each goal are shown: simulated cardiopulmonary resuscitation (CPR) and intubation on a mannequin (life-prolonging care) and a patient resting on a bed receiving pain medications and oxygen therapy by a nurse (comfort care). The aim of this study is to assess the feasibility and acceptability of the video decision aid in end-of-life decision making in community-dwelling older adults in Hong Kong.

Who can participate?
Patients aged 60 or over with multimorbidity (two or more chronic medical conditions)

What does the study involve?
Participating elderly communities are randomly allocated to either the control group or the video group. A 45-minute educational talk is delivered to all participants. In both groups, a trained member of the research team presents the verbal narrative on the goals of medical care (life-prolonging care and comfort care) using PowerPoint slides. A set of 30-page PowerPoint slides are presented to all participants on a projected screen. Photos, graphic illustrations and simple written description using lay language are included in the PowerPoint slides. Identical PowerPoint slides with a structured script are used for all educational talks. The PowerPoint slides cover background information regarding poor prognosis of multimorbidity in older adults, detailed descriptions of different levels of medical care (life-prolonging care vs comfort care) and various components of advance care planning in Hong Kong. Life-prolonging care is described as any available medical care to prolong life including CPR, mechanical ventilation, artificial hydration, and artificial nutrition. Comfort care is described as any medical or nursing care to maximize comfort and to relieve pain. Participants in the intervention group also listen to the same verbal narrative using the same set of PowerPoint slides as the control group, followed by a 6-minute video on a projected screen. The 6-minute ACP video illustrates life-sustaining treatments and comfort care options using the same definitions as the verbal narrative, and also includes visual images and videos of the typical treatments. The 6-minute video contains images of simulated chest compressions, mechanical intubation and intravenous medicine injection on a mannequin. Visual images of artificial nutrition (nasal gastric tube feeding), artificial hydration (intravenous fluid) are also shown. Visual images of a mannequin who is receiving oxygen therapy with a nasal cannula resting on bed, representing comfort care, are also shown. The video is filmed with an unbiased approach. No visual or verbal prompts are used to ensure realism and avoid prompting of decision making. No actors or special effects are used. Traditional Chinese dubbing and labels are added to improve readability. The talk and the video are delivered in Cantonese. Participants are asked to complete a questionnaire before and after the intervention on its acceptability and their EOL preferences.

What are the possible benefits and risks of participating?
Through participating in the intervention, participants may gain a better understanding of EOL care issues in order to make informed decisions on personal future EOL care. There are no risks or physical harms of taking part in this study.

Where is the study run from?
District Elderly Community Center (DECC) in Kwun Tong, Choi Fok, Tuen Mun (Hong Kong)

When is the study starting and how long is it expected to run for?
September 2017 to July 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Ching Ting Lai

Trial website

Contact information

Type

Public

Primary contact

Miss Ching Ting Lai

ORCID ID

Contact details

5B Sun Ho Court
29-31 Tung Lo Wan Rd
Causeway Bay
Hong Kong
00000
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Effect of video decision aid for improving end-of-life care planning for community-dwelling older adults in Hong Kong: a cluster randomized controlled trial

Acronym

Study hypothesis

Primary hypothesis: older adults in the intervention arm would be more readily to discuss end-of-life (EOL) care preference compared to those patients who received usual care.
Secondary hypothesis: older adults in the intervention group would have better knowledge about life-sustaining treatments.

Ethics approval

Survey and Behavioral Research Ethics Committee of the Chinese University of Hong Kong, 30/11/2016

Study design

Multi-site cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

The effects of video decision aids on advance care planning

Intervention

A 6-minute video decision aid (DA) was developed. Visual images comprising each goal were shown: simulated CPR and intubation on mannequin (life-prolonging care) and a patient rest on bed receiving pain medications and oxygen therapy by a nurse (comfort care).

In order to determine the feasibility and acceptability of a video DA in EOL decision making in community-dwelling older adults in Hong Kong, a pilot study is performed. This is a one-group pre-test post-test study. Older adults are recruited from elderly centres. A 6-minute video DA is shown followed by a 30-minute talk to clarify questions. Participants are asked to complete a questionnaire before and after the intervention on its acceptability and their EOL preferences. Chi-square test is performed to compare their preferences at the two time points.

In the main study, there will be multi-sites cluster randomisation. Several elderly communities who join the study will be randomly allocated to either control arm or video arm using a computer-generated allocation sequence.

A 45-minutes educational talk will be delivered to the subjects. In both groups, a trained member of the research team will present the verbal narrative on the goals of medical care (life-prolonging care and comfort care) using PowerPoint slides. A set of 30-page PowerPoint slides will be presented to all subjects on a projected screen. Photos, graphic illustrations and simple written description using lay language will be included in the PowerPoint slides. Identical PowerPoint slides follow with structured script will be used for all educational talks. The PowerPoint slides will cover background information regarding poor prognosis of multimorbidity in older adults, detailed description of different levels of medical care (life-prolonging care vs comfort care) and various component of advance care planning in Hong Kong. The EOL care framework was adopted from previous similar research and validated by experts. Life-prolonging care will be described as any available medical care to prolong life including cardiopulmonary resuscitation, mechanical ventilation, artificial hydration, artificial nutrition (Volandes et al., 2012; HAHO, 2015). Comfort care will be described as any medical or nursing care to maximize comfort and to relieve pain (Volandes et al., 2012; HAHO, 2015).

Subjects in the intervention group will listen to the same verbal narrative using the same set of PowerPoint slides as the control group followed by a 6-minute video on a projected screen. The 6-minute ACP VDA illustrates life-sustaining treatments and comfort care options using the same definitions as the verbal narrative, and also includes visual images and video of the typical treatments. The VDA was developed in a systematic approach followed by a comprehensive literature review and internet search. The ACP VDA was reviewed by an expert panel comprises of physicians and nurses and it was developed through an iterative process. The 6-minute video contains images of simulated chest compressions, mechanical intubation and intravenous medicines injection on a mannequin. Visual images of artificial nutrition (nasal gastric tube feeding), artificial hydration (intravenous fluid) will also be shown. Visual images of a mannequin who is receiving oxygen therapy with nasal cannula resting on bed representing comfort care will also be shown. The video is filmed with an unbiased approach. No visual or verbal prompts were used to ensure realism and avoid prompting of decision making. No actors or special effects were used. Traditional Chinese dubbing and labels were added to improve readability. The talk and the video will be delivered in Cantonese.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Readiness to participate in advanced care planning, measured by a Readiness ruler with 5-point scale at T0 (baseline, before the intervention) and T1 (immediately after the intervention)

Secondary outcome measures

Measured at T0 (baseline, before the intervention) and T1 (immediately after the intervention):
1. Knowledge of EOL care planning, measured by 5 knowledge questionnaires
2. Decisional conflicts towards EOL care choices, measured by SURE test
3. Care preferences, measured by participants’ self-stated care preferences (comfort care vs life-prolonging care)

Overall trial start date

01/09/2017

Overall trial end date

01/07/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 60 or above
2. Multimorbidity
3. Able to communicate in Cantonese
4. Able to provide informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

n=83 per group with n=10-20 per cluster in each centre

Participant exclusion criteria

1. Cognitive impairment (AMT < 6 )
2. Severe deafness or severe visual impairment

Recruitment start date

11/11/2017

Recruitment end date

11/11/2018

Locations

Countries of recruitment

Hong Kong

Trial participating centre

District Elderly Community Center (DECC) in Kwun Tong, Choi Fok, Tuen Mun
00000
Hong Kong

Sponsor information

Organisation

Association of Hong Kong Nursing Staff

Sponsor details

Kowloon Jordan White Gas Street 25
Hong Kong
00000
Hong Kong

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Miss Ching Ting Lai. Individual participant data that underline the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose for individual participant data meta-analysis. To gain access, data requestors will need to sign a data access agreement.

Intention to publish date

01/07/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes