Frail Elderly SyndromeNCT03508557
Implementing Advance Care Planning Conversation Tools in Family Practice
A study testing Advance care planning tools in people with Frail Elderly Syndrome and Chronic Disease, run by McMaster University at 4 sites in Canada.
Trial summary
This study evaluates the use of advance care planning conversation tools with patients attending their family doctor's office. Patients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Chronic Disease
- What is being tested?
- Advance care planning tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Jun 2018to 30 Oct 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 60 or older
- chronic condition that may reduce life expectancy as per physician's clinical judgement
- able to communicate verbally in English and read English
Who cannot join
- unable to communicate verbally in English
- unable to read English
- cognitively unable to give informed consent (e.g. memory problems) as judged by referring physician or research assistant
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Sunridge Family Medicine Teaching Centre
Calgary, Alberta, T1Y 5S3
Safa Medical Clinic
Langley, British Columbia
New Westminster Family Practice
Vancouver, British Columbia, V3L 3C2
Vancouver General Hospital Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia
About this study
This study evaluates the use of advance care planning conversation tools with patients attending their family doctor's office. Patients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. The patient's family member/substitute decision-maker is encouraged to attend and be part of the discussions.
Read the detailed description
Structured tools are helpful for advance care planning. Tools have been developed to help with advance care planning because it is a process which has multiple steps and people involved. This study will help health care teams in primary care learn to use the tools with frail or older seriously ill patients and will evaluate the perceptions of patients, family members and health care providers, as well as the impact of having the discussions on subsequent health care interactions the patient has.
Patients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. The patient's family member/substitute decision-maker is encouraged to attend and be part of the discussions.
- Conditions
- Frail Elderly Syndrome, Chronic Disease
- Being tested
- Advance care planning tools
- 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 toolsBehavioural
Structured conversations between patients/substitute decision-maker and clinician based on education about advance care planning using locally relevant booklet/website, values clarification tool for patient engagement, clinician use of the Serious Illness Conversation Guide
| Study group | Role | What they receive |
|---|---|---|
| Advance care planning tools | Experimental | Advance care planning education and structured conversation using tools Receives: Behavioral: Advance care planning tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advance care planning engagement
Survey measuring domains of engagement in advance care planning
Measured: 12 weeks
Secondary outcomes (3)
Advance care planning engagement-substitute decision maker
survey measuring substitute decision maker domains of engagement in advance care planning
Measured: 12 weeks
Patient experience
survey of patient experience with intervention
Measured: 12 weeks
Patient perceived impact on health care
qualitative interviews of patients asking perceived impact of intervention on later health care use
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start1 Jun 2018
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group before-after
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Frailty Network
- Responsible party
- Principal investigator, Michelle Howard, McMaster University
- Investigators
- Michelle Howard, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508557
- Sponsor's protocol ID
- TG2015-03D
- Status last verified
- Jan 2022
- First submitted
- 16 Apr 2018
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stevens J, Elston D, Tan A, Barwich D, Carter RZ, Cochrane D, Frenette N, Howard M. Clinicians' experiences implementing an advance care planning pathway in two Canadian provinces: a qualitative study. BMC Prim Care. 2024 Jun 15;25(1):217. doi: 10.1186/s12875-024-02468-4.
PubMed 38879532
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Advance Care Planning Conversation Tools in Family Practice
- ClinicalTrials.gov ID
- NCT03508557
- Acronym / sponsor ID
- TG2015-03D
- Conditions
- Frail Elderly Syndrome, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Frailty Network
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 25 Apr 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.
This study evaluates the use of advance care planning conversation tools with patients attending their family doctor's office. Patients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. The patient's family member/substitute decision-maker is encouraged to attend and be part of the discussions.
Detailed description
Structured tools are helpful for advance care planning. Tools have been developed to help with advance care planning because it is a process which has multiple steps and people involved. This study will help health care teams in primary care learn to use the tools with frail or older seriously ill patients and will evaluate the perceptions of patients, family members and health care providers, as well as the impact of having the discussions on subsequent health care interactions the patient has.
Patients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. The patient's family member/substitute decision-maker is encouraged to attend and be part of the discussions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group before-after
| Arm | Type | Receives |
|---|---|---|
| Advance care planning tools | Experimental | Behavioral: Advance care planning toolsAdvance care planning education and structured conversation using tools |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 60 or older
- chronic condition that may reduce life expectancy as per physician's clinical judgement
- able to communicate verbally in English and read English
Key exclusion criteria (3 listed)
- unable to communicate verbally in English
- unable to read English
- cognitively unable to give informed consent (e.g. memory problems) as judged by referring physician or research assistant
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 toolsStructured conversations between patients/substitute decision-maker and clinician based on education about advance care planning using locally relevant booklet/website, values clarification tool for patient engagement, clinician use of the Serious Illness Conversation Guide | Behavioural | Advance care planning tools |
Primary outcome
Advance care planning engagement
Time frame: 12 weeks
Survey measuring domains of engagement in advance care planning
3 secondary outcomes
Advance care planning engagement-substitute decision maker
Time frame: 12 weeks
Patient experience
Time frame: 12 weeks
Patient perceived impact on health care
Time frame: 6-9 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 Jan 2022.
- Derived from this study: PubMed 38879532Stevens J, Elston D, Tan A, Barwich D, Carter RZ, Cochrane D, Frenette N, Howard M. Clinicians' experiences implementing an advance care planning pathway in two Canadian provinces: a qualitative study. BMC Prim Care. 2024 Jun 15;25(1):217. doi: 10.1186/s12875-024-02468-4.
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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.
Michelle Howard, PhD principal investigator
McMaster University
4 sites 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 tools in people with Frail Elderly Syndrome and Chronic Disease, run by McMaster University at 4 sites in Canada.
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 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Advance care planning engagement (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03508557, which also lists 1 linked publication.
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 Jan 2022.