- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03297320
Advance Care Planning at London Health Sciences Centre (ACP@LHSC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
4. 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.
5. 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5A5
- Recruiting
- London Health Sciences Centre
-
Contact:
- Ravi Taneja, FRCPC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Team Referrals
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)
|
In-depth conversation regarding Goals of Care and ACP by an experienced practitioner
|
|
Active Comparator: Random selection
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)
|
In-depth conversation regarding Goals of Care and ACP by an experienced practitioner
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Discordance
Time Frame: 2 years
|
Discordance between patients' prior expressed preferences and those documented in their healthcare record
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors associated with discordance
Time Frame: 2 years
|
Evaluate predisposing factors for the discordance
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ravi Taneja, FRCPC, Western University, Canada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R-16-299
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advance Care Planning
-
Southcentral FoundationUniversity of Colorado, Denver; University of Washington; University of Arkansas and other collaboratorsRecruiting
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingAdvance Care PlanningUnited States
-
Tufts Medical CenterNational Institute of Nursing Research (NINR); University of Hawaii; Queen's...Active, not recruiting
-
University of PittsburghCompletedAdvance Care PlanningUnited States
-
The University of Hong KongNot yet recruitingAdvance Care Planning
-
King's College LondonPrincess Alice HospiceCompleted
-
Duke UniversityCompletedAdvance Care PlanningUnited States
-
Southcentral FoundationUniversity of Colorado, Denver; University of Washington; Washington State University and other collaboratorsCompletedAdvance Care PlanningUnited States
-
Liverpool University Hospitals NHS Foundation TrustUniversity of LiverpoolCompleted
-
Duke UniversityCompletedAdvance Care PlanningUnited States
Clinical Trials on In-depth conversation about Goals of Care and ACP
-
Memorial Sloan Kettering Cancer CenterCompleted
-
University of MelbourneEnrolling by invitationICU Acquired Weakness | Intensive Care Unit Syndrome | Intensive Care Unit Acquired Weakness | Post Intensive Care Unit Syndrome | Post Intensive Care SyndromeAustralia
-
University of California, San DiegoCompleted
-
Hasselt UniversityNot yet recruiting
-
lliana Ulloa SabogalUnknownBreastfeeding, ExclusiveColombia
-
Memorial Sloan Kettering Cancer CenterCompletedLung Cancer Screening | Current or Past Cigarette SmokerUnited States
-
Indiana UniversityNational Institute on Aging (NIA); Regenstrief Institute, Inc.; Hebrew SeniorLifeCompletedDementia | Alzheimer DiseaseUnited States
-
M.D. Anderson Cancer CenterRecruitingLung Cancer | Gastrointestinal CancerUnited States
-
Bambino Gesù Hospital and Research InstituteNational Alliance for Research on Schizophrenia and Depression; OrygenUnknown22q11 Deletion SyndromeHoly See (Vatican City State)
-
Institute of HIV Research and Innovation Foundation...International AIDS SocietyRecruitingHIV Prevention | Substance Use | Mental Health | Sexually Transmitted Infections (STIs)Thailand