End Stage DiseaseNCT03599310
Effects of a Structured Advance Care Planning Guide Among Patients With Advanced Illness in Hospital Care Settings
A study testing Advance care planning in people with End Stage Disease, run by Food and Health Bureau, Hong Kong at 1 site in Hong Kong.
Trial summary
Objective: To examine the effects of a structured advance care planning (ACP) guide among patients with advanced illness in hospital care setting. Methods: This is a 24-month stepped-wedge cluster randomised controlled trial to be conducted in the Department of Medicine in an acute hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Disease
- What is being tested?
- Advance care planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2017to 31 Jul 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or over;
- meet either two general indicators of health deterioration or one clinical indicator of an advanced illness condition in the Supportive and Palliative Care Indicators Tool (SPICT); and
- able to communicate in Cantonese.
Who cannot join
- mentally incompetent or unable to communicate;
- receiving psychiatric treatment; or
- have been referred to the palliative care service at the time of recruitment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Structured Advance Care Planning Guide Among Patients With Advanced Illness in Hospital Care Settings: a Stepped-wedge Cluster Randomised Controlled Trial
Objective: To examine the effects of a structured advance care planning (ACP) guide among patients with advanced illness in hospital care setting.
Methods: This is a 24-month stepped-wedge cluster randomised controlled trial to be conducted in the Department of Medicine in an acute hospital. Patients are eligible to the study if they are aged 18 or over, are communicable, and meet the indicators of health deterioration or advanced condition in the Supportive and Palliative Care Indicators Tool (SPICT). Ward nurses will be trained to be interventionists to conduct ACP by means of a structured ACP guide. The guide is adapted from a culturally sensitive ACP programme developed in the local context with reference to the format of the Serious Illness Communication Guide, which is an evidence-based best practice in end-of-life care communication to support the ACP process.
Main outcome measures: Data will be collected at baseline (T0), one week (T1), three months (T2) and six months (T3) after intervention. The primary study outcome is the documentation of ACP discussion in medical records and completion of advance directives. Secondary outcomes are communicating end-of-life care preferences with family carers, quality of life and concordance of care preferences and treatment provided.
Read the detailed description
Advance care planning (ACP) is defined as a communication process among patients, their family members and healthcare providers about end-of-life care, before the patients lose their capacity to decide for themselves. The main purpose of this study is to embed ACP into the usual care process in acute hospital setting through building staff capacity to conduct ACP. This will be a 24-month stepped-wedge cluster randomised controlled trial, with randomization built into the phasing of intervention implementation. This crossover design enables all study venues sequentially switched from control to experimental. This study will be conducted in all eight wards of the medical department of an 800-bed acute hospital. The ACP in this study is a facilitator-based intervention with a structured communication guide as a tool to aid the interventionists in broaching end-of-life care issues and eliciting patients' values and preferences in a consistent manner. The primary study outcome is the documentation of ACP discussion in medical records. Secondary outcomes are communicating end-of-life care preferences with family carers, quality of life and concordance of care preferences and treatment provided. Data collection will be conducted at baseline, one week, three months and six months after intervention.
- Conditions
- End Stage Disease
- Being tested
- Advance care planning, Usual care
- Keywords
- Advance care planning, Communication, Nurse, End-of-life
- Medical subject headings
- Communication, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance care planningBehavioural
The ACP guide is adapted from the Serious Illness Communication Guide and a culturally-sensitive ACP programme developed in the local context. The trained ACP facilitators will initiate the conversation by introducing the concepts of ACP with the support of the guide and assessing the patient's illness understanding and readiness to think about end-of-life care issues.
Usual careBehavioural
In the current practice, patients will have to take the initiative themselves if they would like to discuss their end-of-life care or make an advance directive.
| Study group | Role | What they receive |
|---|---|---|
| Advance care planning | Experimental | The intervention is a facilitator-based ACP process with a structured guide as a communication tool to aid the interventionists in broaching end-of-life care issues and eliciting patients' values and preferences in a consistent manner. Receives: Behavioral: Advance care planning |
| Usual care | Placebo comparator | A leaflet covering the concept of ACP and advance directives (AD), purposes and potential benefits will be distributed to all participants as part of usual information support to standardize the information provided. The health care team will encourage patients to discuss the matters with their family carers and/or significant others. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation
Documentation of ACP discussion in medical record
Measured: 3 months
Secondary outcomes (3)
Family communication
Communication of end-of-life care preferences with family members
Measured: 3 months
Self perceived quality-of-life of patients
Quality-of-life concerns at the end of life (QOLC-E)
Measured: 3 months
Concordance of care
Concordance of care preferences and actual
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Food and Health Bureau, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Yan Chai Hospital
- Responsible party
- Principal investigator, Dr. Helen YL Chan, Chinese University of Hong Kong
- Investigators
- Helen Y Chan, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599310
- Sponsor's protocol ID
- 14152631
- Status last verified
- Nov 2019
- First submitted
- 15 Jul 2018
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Health conditions only
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Structured Advance Care Planning Guide Among Patients With Advanced Illness in Hospital Care Settings: a Stepped-wedge Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03599310
- Acronym / sponsor ID
- 14152631
- Conditions
- End Stage Disease
- Keywords
- Advance care planning, Communication, Nurse, End-of-life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Food and Health Bureau, Hong KongOther government
- Collaborators
- Yan Chai Hospital
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 26 Jul 2018 (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.
Objective: To examine the effects of a structured advance care planning (ACP) guide among patients with advanced illness in hospital care setting.
Methods: This is a 24-month stepped-wedge cluster randomised controlled trial to be conducted in the Department of Medicine in an acute hospital. Patients are eligible to the study if they are aged 18 or over, are communicable, and meet the indicators of health deterioration or advanced condition in the Supportive and Palliative Care Indicators Tool (SPICT). Ward nurses will be trained to be interventionists to conduct ACP by means of a structured ACP guide. The guide is adapted from a culturally sensitive ACP programme developed in the local context with reference to the format of the Serious Illness Communication Guide, which is an evidence-based best practice in end-of-life care communication to support the ACP process.
Main outcome measures: Data will be collected at baseline (T0), one week (T1), three months (T2) and six months (T3) after intervention. The primary study outcome is the documentation of ACP discussion in medical records and completion of advance directives. Secondary outcomes are communicating end-of-life care preferences with family carers, quality of life and concordance of care preferences and treatment provided.
Detailed description
Advance care planning (ACP) is defined as a communication process among patients, their family members and healthcare providers about end-of-life care, before the patients lose their capacity to decide for themselves. The main purpose of this study is to embed ACP into the usual care process in acute hospital setting through building staff capacity to conduct ACP. This will be a 24-month stepped-wedge cluster randomised controlled trial, with randomization built into the phasing of intervention implementation. This crossover design enables all study venues sequentially switched from control to experimental. This study will be conducted in all eight wards of the medical department of an 800-bed acute hospital. The ACP in this study is a facilitator-based intervention with a structured communication guide as a tool to aid the interventionists in broaching end-of-life care issues and eliciting patients' values and preferences in a consistent manner. The primary study outcome is the documentation of ACP discussion in medical records. Secondary outcomes are communicating end-of-life care preferences with family carers, quality of life and concordance of care preferences and treatment provided. Data collection will be conducted at baseline, one week, three months and six months after intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advance care planning | Experimental | Behavioral: Advance care planningThe intervention is a facilitator-based ACP process with a structured guide as a communication tool to aid the interventionists in broaching end-of-life care issues and eliciting patients' values and preferences in a consistent manner. |
| Usual care | Placebo comparator | Behavioral: Usual careA leaflet covering the concept of ACP and advance directives (AD), purposes and potential benefits will be distributed to all participants as part of usual information support to standardize the information provided. The health care team will encourage patients to discuss the matters with their family carers and/or significant others. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years or over;
- meet either two general indicators of health deterioration or one clinical indicator of an advanced illness condition in the Supportive and Palliative Care Indicators Tool (SPICT); and
- able to communicate in Cantonese.
Key exclusion criteria (3 listed)
- mentally incompetent or unable to communicate;
- receiving psychiatric treatment; or
- have been referred to the palliative care service at the time of recruitment.
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 |
|---|---|---|
| Advance care planningThe ACP guide is adapted from the Serious Illness Communication Guide and a culturally-sensitive ACP programme developed in the local context. The trained ACP facilitators will initiate the conversation by introducing the concepts of ACP with the support of the guide and assessing the patient's illness understanding and readiness to think about end-of-life care issues. | Behavioural | Advance care planning |
| Usual careIn the current practice, patients will have to take the initiative themselves if they would like to discuss their end-of-life care or make an advance directive. | Behavioural | Usual care |
Primary outcome
Documentation
Time frame: 3 months
Documentation of ACP discussion in medical record
3 secondary outcomes
Family communication
Time frame: 3 months
Self perceived quality-of-life of patients
Time frame: 3 months
Concordance of care
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No. Health conditions only
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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.
Helen Y Chan, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance care planning in people with End Stage Disease, run by Food and Health Bureau, Hong Kong at 1 site in Hong Kong.
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 3 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: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Documentation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2019.