Chronic DiseaseNCT02068651
A Community-based Advance Care Planning Programme for Patients With Advanced Disease
A study testing Advance care planning programme in people with Chronic Disease, run by Food and Health Bureau, Hong Kong at 1 site in Hong Kong.
Trial summary
Advance care planning has been recommended as an integral part of care for patients with life-limiting disease, but relevant development in Hong Kong is still in its infancy. This proposed study attempts to address this service gap by promoting advance care planning to patients with advanced disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Advance care planning programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2014to Mar 2016
- 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 or above
- meet one of the three triggers for supportive /palliative care as suggested in the Gold Standards Framework
- living at home
- being communicable
Who cannot join
- mentally incompetent
- cannot nominate a family carer
- have already signed an advance directive
- have been referred to palliative care service
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community-based Advance Care Planning Programme to Improve End-of-life Care in Patients With Advanced Disease: A Mixed-method Approach
Advance care planning has been recommended as an integral part of care for patients with life-limiting disease, but relevant development in Hong Kong is still in its infancy. This proposed study attempts to address this service gap by promoting advance care planning to patients with advanced disease. It is hypothesized that the proportion of patients whose end-of-life care preferences were known in the experimental group will be significantly higher than that in the control group.
Read the detailed description
This study aims to evaluate the impacts of a community-based advance care planning programme on end-of-life care of patients with advanced disease. A mixed-method approach, including a randomized controlled trial and qualitative interviews, will be used. Participants in the experimental group will received a structured advance care planning programme delivered by a trained facilitator. It includes an educational component, reflection and a family meeting.
- Conditions
- Chronic Disease
- Being tested
- Advance care planning programme
- Keywords
- End-of-life care, Treatment decision making, Advance care planning
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance care planning programmeBehavioural
It is a multi-faceted programme which includes an educational component with support of multimedia materials, reflection on personal values and a facilitated discussion between patient and family carer over future care. It will be delivered to each pair of participant and family carer on individual basis. By the end of the programme, each participant will have a personal workbook summarising the advance care planning process for record.
| Study group | Role | What they receive |
|---|---|---|
| Advance care planning programme | Experimental | Participants in the experimental group will receive a structured advance care planning programme, namely Let Me Talk, delivered by a trained nurse facilitator. The programme will be conducted on individual basis through three one-hour home visits, once weekly. Family carers of the participants will be invited to all sessions. Receives: Behavioral: Advance care planning programme |
| Usual care | No intervention | Participants in the control group will receive three weekly home visits with basic health assessment and education provided by the trained nurse facilitator. If they request advance care planning information or assistance, an advance directive form, which is available on the Internet for public access, will be provided to them for their information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-of-life care preferences
In this study, end-of-life care preferences include goal for end-of-life care and decisions over the use of life-sustaining treatments relevant to individual's anticipated health changes. So, whether the patients' end-of-life care preferences is known at different timepoints will be determined based on (1) the congruence between patients' end-of-life care preferences and family carers' predicted end-of-life care preferences for patients; and (2) whether patients' end-of-life preferences are documented in their medical record.
Measured: 6 months
Secondary outcomes (2)
Level of certainty about future care
The SURE test (Legare, Kearing, Clay, Gagnon, D'Amours, Rousseau \& O'Connor, 2010) will be used to measure the patient's level of decisional conflict in making decisions related to future care. Patients will be asked to rate their certainty in their future care on four items by using a dichotomous response format: yes or no. Good construct validity and reliability were demonstrated. It has previously been translated into Chinese and tested among local older people .
Measured: 6 months
Health care utilization
Patient's medical records will be retrieved retrospectively six months after their enrolment to review their health care utilization over the study period, including the number of visits to the emergency department, unplanned admission, length of hospital stay, as well as investigation, procedures and treatment received.
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 posted21 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Food and Health Bureau, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Helen YL Chan, Chinese University of Hong Kong
- Investigators
- Helen Chan, RN PhD, Principal investigator, The Nethersole School of Nursing, The Chinese University of Hong KongDiana Lee, RN PhD, Principal investigator, The Nethersole School of Nursing, The Chinese University of Hong KongCarmen Chan, RN PhD, Principal investigator, The Nethersole School of Nursing, The Chinese University of Hong KongIris Lee, RN PhD, Principal investigator, The Nethersole School of Nursing, The Chinese University of Hong KongDoris Leung, PhD, Principal investigator, The Nethersole School of Nursing, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068651
- Sponsor's protocol ID
- 11120861
- Status last verified
- Aug 2016
- First submitted
- 13 Feb 2014
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Advance Care Planning Programme to Improve End-of-life Care in Patients With Advanced Disease: A Mixed-method Approach
- ClinicalTrials.gov ID
- NCT02068651
- Acronym / sponsor ID
- 11120861
- Conditions
- Chronic Disease
- Keywords
- End-of-life care, Treatment decision making, Advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Food and Health Bureau, Hong KongOther government
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Feb 2014 (estimated)
- 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.
Advance care planning has been recommended as an integral part of care for patients with life-limiting disease, but relevant development in Hong Kong is still in its infancy. This proposed study attempts to address this service gap by promoting advance care planning to patients with advanced disease. It is hypothesized that the proportion of patients whose end-of-life care preferences were known in the experimental group will be significantly higher than that in the control group.
Detailed description
This study aims to evaluate the impacts of a community-based advance care planning programme on end-of-life care of patients with advanced disease. A mixed-method approach, including a randomized controlled trial and qualitative interviews, will be used. Participants in the experimental group will received a structured advance care planning programme delivered by a trained facilitator. It includes an educational component, reflection and a family meeting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advance care planning programme | Experimental | Behavioral: Advance care planning programmeParticipants in the experimental group will receive a structured advance care planning programme, namely Let Me Talk, delivered by a trained nurse facilitator. The programme will be conducted on individual basis through three one-hour home visits, once weekly. Family carers of the participants will be invited to all sessions. |
| Usual care | No intervention | –Participants in the control group will receive three weekly home visits with basic health assessment and education provided by the trained nurse facilitator. If they request advance care planning information or assistance, an advance directive form, which is available on the Internet for public access, will be provided to them for their information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18 or above
- meet one of the three triggers for supportive /palliative care as suggested in the Gold Standards Framework
- living at home
- being communicable
Key exclusion criteria (4 listed)
- mentally incompetent
- cannot nominate a family carer
- have already signed an advance directive
- have been referred to palliative care service
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 planning programmeIt is a multi-faceted programme which includes an educational component with support of multimedia materials, reflection on personal values and a facilitated discussion between patient and family carer over future care. It will be delivered to each pair of participant and family carer on individual basis. By the end of the programme, each participant will have a personal workbook summarising the advance care planning process for record. | Behavioural | Advance care planning programme |
Primary outcome
End-of-life care preferences
Time frame: 6 months
In this study, end-of-life care preferences include goal for end-of-life care and decisions over the use of life-sustaining treatments relevant to individual's anticipated health changes. So, whether the patients' end-of-life care preferences is known at different timepoints will be determined based on (1) the congruence between patients' end-of-life care preferences and family carers' predicted end-of-life care preferences for patients; and (2) whether patients' end-of-life preferences are documented in their medical record.
2 secondary outcomes
Level of certainty about future care
Time frame: 6 months
Health care utilization
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 19 Aug 2016.
- Individual participant dataSharing planned: No
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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 Chan, RN PhD principal investigator
The Nethersole School of Nursing, The Chinese University of Hong Kong
Diana Lee, RN PhD principal investigator
The Nethersole School of Nursing, The Chinese University of Hong Kong
Carmen Chan, RN PhD principal investigator
The Nethersole School of Nursing, The 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 programme in people with Chronic 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 4 inclusion and 4 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 19 Aug 2016. 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. 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?
End-of-life care preferences (time frame: 6 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 19 Aug 2016.