Advance Care Planning at London Health Sciences Centre (ACP@LHSC)

September 26, 2017 updated by: Lawson Health Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. 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.
  2. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences Centre
        • Contact:
          • Ravi Taneja, FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients admitted to internal medicine teams at or after hospitalization day 2 with:

  1. 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
  2. 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:

  1. Lack of written consent
  2. Patients who do not speak English; hard of hearing
  3. Expected to die or be discharged ≤ 24 hours
  4. Referral to or having an established palliative care plan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Other: In-depth conversation about Goals of Care and ACP
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)
Other: In-depth conversation about Goals of Care and ACP
In-depth conversation regarding Goals of Care and ACP by an experienced practitioner

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ravi Taneja, FRCPC, Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R-16-299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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