Advance Care PlanningACP@LHSCNCT03297320
Advance Care Planning at London Health Sciences Centre
A study testing In-depth conversation about Goals of Care and ACP in people with Advance Care Planning, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
All patients admitted to London Health Sciences Centre (LHSC) are asked to indicate their preferences for CPR (cardiopulmonary resuscitation) and other life-sustaining treatments that necessitate an Intensive Care Unit (ICU) admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- In-depth conversation about Goals of Care and ACP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2017to 31 Mar 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
- Patients admitted to internal medicine teams at or after hospitalization day 2 with:
- Age ≥55 years with ≥1 diagnoses: Chronic lung disease, Coronary artery disease, Congestive heart failure, Cirrhosis, Renal failure, Diabetes, Peripheral vascular disease, Cancer, Dementia (inability with ADLs) or
- If none of these criteria were met, any patient whose death within the next 1 year would not surprise health-care team members.
Who cannot join
- Lack of written consent
- Patients who do not speak English; hard of hearing
- Expected to die or be discharged ≤ 24 hours
- Referral to or having an established palliative care plan
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Ravi Taneja, FRCPC
About this study
All patients admitted to London Health Sciences Centre (LHSC) are asked to indicate their preferences for CPR (cardiopulmonary resuscitation) and other life-sustaining treatments that necessitate an Intensive Care Unit (ICU) admission.
Complex, high-risk patients at LHSC require multiple admissions to the hospital towards their end-of-life (EOL). Documentation of their resuscitation status should be a part of a broader dialogue with patients around their goals of care (GOC) and advance care planning (ACP), but rarely is this the case.
The innovation will involve the use of trained nurse facilitators to have meaningful conversations with patients and their families in an effective way that bridges the gap between resuscitation status, GOC discussions and ACP across the continuum of care.
Read the detailed description
- On admission, the usual LHSC process will be followed whereby the patient's wishes for resuscitation are documented on the resuscitation record in the patient's chart. This constitutes the "original" resuscitation status.
- After referral or screening and written consent, the RA will conduct semi-structured, face-to-face interviews with the patient and or SDM as appropriate. If the RA has concern about a discordance, he/she will then provide verbal feedback to the health-care team (Attending Physician or the Senior Medical Resident (SMR)) immediately and request them to communicate with the patient/SDM again. A case of discordance shall be recorded ONLY if the health-care team (Attending Physician or Senior Medical Resident) confirms that a change in resuscitation status is needed. The output of this intervention will be the "revised" resuscitation status. This "standardized" process for determining this outcome has worked well in our pilot study. Any disagreements between RA and SMR on patient/SDM preferences will be reported to Team#1 Attending and recorded. It will be up to the team to reconcile the "revised" resuscitation preferences on official records (Resuscitation status can only be filled in only by an MD as per hospital policy).
- Advanced Clinical Notes: These will be typed by the RA and a note be made of the "revised" resuscitation preferences along with GOC and ACP discussions.
- A pilot study related to this work started in August 2016 and has allowed the research team to evaluate barriers and facilitators of conducting this intervention on Internal Medicine patients.
- Conditions
- Advance Care Planning
- Being tested
- In-depth conversation about Goals of Care and ACP
- Keywords
- Advance Care Planning, End of life, CPR
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-depth conversation about Goals of Care and ACPOther
In-depth conversation regarding Goals of Care and ACP by an experienced practitioner
| Study group | Role | What they receive |
|---|---|---|
| Team Referrals | Active comparator | In-depth conversations about Goals of Care and ACP (the intervention) will be held for the patients referred to the research team by the three healthcare teams in Internal Medicine at London Health Sciences Centre (University Campus) Receives: Other: In-depth conversation about Goals of Care and ACP |
| Random selection | Active comparator | A random selection of patients (not referred to the research team by the healthcare team) in Internal Medicine at London Health Sciences Centre (University Campus) will be selected to have in-depth conversations about Goals of Care and ACP (the intervention) Receives: Other: In-depth conversation about Goals of Care and ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Discordance
Discordance between patients' prior expressed preferences and those documented in their healthcare record
Measured: 2 years
Secondary outcomes (1)
Risk factors associated with discordance
Evaluate predisposing factors for the discordance
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthcare teams in Internal Medicine at London Health Sciences Centre will be asked if they have any patients that need further goals of care discussions or ACP. A random selection of Internal Medicine patients will also be selected for further indepth conversations related to goals of care discussions or ACP
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Taneja, FRCPC, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297320
- Sponsor's protocol ID
- R-16-299
- Acronym
- ACP@LHSC
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advance Care Planning at London Health Sciences Centre
- ClinicalTrials.gov ID
- NCT03297320
- Acronym / sponsor ID
- ACP@LHSC / R-16-299
- Conditions
- Advance Care Planning
- Keywords
- Advance Care Planning, End of life, CPR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 29 Sep 2017 (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.
All patients admitted to London Health Sciences Centre (LHSC) are asked to indicate their preferences for CPR (cardiopulmonary resuscitation) and other life-sustaining treatments that necessitate an Intensive Care Unit (ICU) admission.
Complex, high-risk patients at LHSC require multiple admissions to the hospital towards their end-of-life (EOL). Documentation of their resuscitation status should be a part of a broader dialogue with patients around their goals of care (GOC) and advance care planning (ACP), but rarely is this the case.
The innovation will involve the use of trained nurse facilitators to have meaningful conversations with patients and their families in an effective way that bridges the gap between resuscitation status, GOC discussions and ACP across the continuum of care.
Detailed description
- On admission, the usual LHSC process will be followed whereby the patient's wishes for resuscitation are documented on the resuscitation record in the patient's chart. This constitutes the "original" resuscitation status.
- After referral or screening and written consent, the RA will conduct semi-structured, face-to-face interviews with the patient and or SDM as appropriate. If the RA has concern about a discordance, he/she will then provide verbal feedback to the health-care team (Attending Physician or the Senior Medical Resident (SMR)) immediately and request them to communicate with the patient/SDM again. A case of discordance shall be recorded ONLY if the health-care team (Attending Physician or Senior Medical Resident) confirms that a change in resuscitation status is needed. The output of this intervention will be the "revised" resuscitation status. This "standardized" process for determining this outcome has worked well in our pilot study. Any disagreements between RA and SMR on patient/SDM preferences will be reported to Team#1 Attending and recorded. It will be up to the team to reconcile the "revised" resuscitation preferences on official records (Resuscitation status can only be filled in only by an MD as per hospital policy).
- Advanced Clinical Notes: These will be typed by the RA and a note be made of the "revised" resuscitation preferences along with GOC and ACP discussions.
- A pilot study related to this work started in August 2016 and has allowed the research team to evaluate barriers and facilitators of conducting this intervention on Internal Medicine patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Healthcare teams in Internal Medicine at London Health Sciences Centre will be asked if they have any patients that need further goals of care discussions or ACP. A random selection of Internal Medicine patients will also be selected for further indepth conversations related to goals of care discussions or ACP
| Arm | Type | Receives |
|---|---|---|
| Team Referrals | Active comparator | Other: In-depth conversation about Goals of Care and ACPIn-depth conversations about Goals of Care and ACP (the intervention) will be held for the patients referred to the research team by the three healthcare teams in Internal Medicine at London Health Sciences Centre (University Campus) |
| Random selection | Active comparator | Other: In-depth conversation about Goals of Care and ACPA random selection of patients (not referred to the research team by the healthcare team) in Internal Medicine at London Health Sciences Centre (University Campus) will be selected to have in-depth conversations about Goals of Care and ACP (the intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥55 years with ≥1 diagnoses: Chronic lung disease, Coronary artery disease, Congestive heart failure, Cirrhosis, Renal failure, Diabetes, Peripheral vascular disease, Cancer, Dementia (inability with ADLs) or
- If none of these criteria were met, any patient whose death within the next 1 year would not surprise health-care team members.
Key exclusion criteria (4 listed)
- Lack of written consent
- Patients who do not speak English; hard of hearing
- Expected to die or be discharged ≤ 24 hours
- Referral to or having an established palliative care plan
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 |
|---|---|---|
| In-depth conversation about Goals of Care and ACPIn-depth conversation regarding Goals of Care and ACP by an experienced practitioner | Other | Random selection, Team Referrals |
Primary outcome
Incidence of Discordance
Time frame: 2 years
Discordance between patients' prior expressed preferences and those documented in their healthcare record
1 secondary outcome
Risk factors associated with discordance
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Individual participant dataSharing planned: No
Related trials for Advance Care Planning
Active, not recruiting
ACP Video Intervention for Patients With Life-Limiting Illness
Health Care Utilization, End Stage Disease
Recruiting
Patient Navigation and the Planning Advance Care Together Website to Improve Goals of Care Conversations in Hematopoietic Cell Transplant Survivors, IMPACT-HCT Trial
Hematopoietic and Lymphatic System Neoplasm
Not yet recruiting
Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
Heart Failure, Older Adults (65 Years and Older)
Not yet recruiting
Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
Advance Care Planning, American Indian or Alaska Native
Active, not recruiting
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplantation
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.
Ravi Taneja, FRCPC principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-depth conversation about Goals of Care and ACP in people with Advance Care Planning, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site 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 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: status not confirmed, as of the sponsor's last update on 29 Sep 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Launa Elliott, BSc (519 685-8500 ext. 32846, Ravi.Taneja@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Discordance (time frame: 2 years). 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 29 Sep 2017.