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Advance Care Planning & Goals of Care Randomized Controlled Trial in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03434626
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : June 19, 2019
Queen's University
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Sometimes people with health conditions become ill suddenly and can no longer speak for themselves and another person (such as a family member) will make health care decisions for them. This means it is important for people to think about their wishes and tell others about them. This is called advance care planning. When people have done advance care planning, if they become very sick and cannot speak for themselves they are more likely to get the kind of health care they want and it is easier for the people who make decisions for them. In Alberta, there is a form in the health care system that is used to indicate a person's wishes if participants are unable to speak for themselves. There are tools such as brochures, questionnaires, and videos that can help participants learn about advance care planning and serious illness conversations. This research is being done to study whether using tools for advance care planning will help improve goals of care designation completion rates in such a way that they better reflect patient values. In this project, we aim to determine the efficacy of tools to increase the quality and quantity of advance care planning (ACP) and Goals of Care Determinations (GCD) in primary care settings in Alberta.

Condition or disease Intervention/treatment Phase
Chronic Illness Comorbidities Behavioral: ACP Education Other: Usual care Not Applicable

Detailed Description:
In prospective and randomized trials, advance care planning (ACP) significantly improves outcomes including increased likelihood that clinicians and families understand and comply with a patient's wishes, reduces hospitalization at the end of life, results in less intensive treatments at the end of life (according to patients' wishes) and increases use of hospice services. Trials have not been done in primary care. The aim of this study is to determine the efficacy of a care pathway designed to increase the quality and quantity of ACP in patients and their substitute decision-makers in primary care. The study is a multi-site, patient-based, unblinded, randomized trial conducted in family practices in Canada. Participants will be patients who are determined by their physician to be able to benefit from ACP, and the patient's substitute decision-maker. Participant pairs will be randomized to immediate intervention (care pathway) or delayed (8-12 weeks). The intervention is guided use of tools and decision aids to clarify values and preferences for treatments in the event of serious illness or near end of life. The outcomes will be presence of a goals of care form in the chart, substitute decision-maker engagement in ACP (including self-efficacy for enacting the role), patient engagement in ACP, and decisional conflict.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor conducting interviews does not have information on group assignment
Primary Purpose: Other
Official Title: A Randomized Trial of ACP/GCD Care Pathway in Primary Care in Alberta
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : September 26, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: ACP Education
Eligible patients in the experimental group will receive an educational intervention from an advance care planning navigator consisting of a 4-item values tool, a Goals of Care Designation form and, if applicable, watch a cardiopulmonary resuscitation video.
Behavioral: ACP Education
Decision aid and Goals of Care Designation form information administered by Navigator

Other: Usual care
Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician

Active Comparator: Usual care
Patients in the usual care group will complete a Goals of Care Designation form with the family physician.
Other: Usual care
Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician

Primary Outcome Measures :
  1. Presence of a completed goals of care designation form in the patient chart [ Time Frame: 8-12 weeks ]
    In Alberta there is a form in the health care system that is used to indicate a person's wishes if they are unable to speak for themselves. The form is called a "Goal of Care Designation" form and is part of a package called the 'Greensleeve'. Alberta Health Services requires that all patients in primary care and in hospital have a green sleeve and goal of care designation (RMC classification: R=resuscitative; M=medical; C=comfort care).

Secondary Outcome Measures :
  1. Agreement between patient's self-reported values and preferences for life sustaining treatment, and what is documented in the form in the chart [ Time Frame: 8-12 weeks ]
    Dichotomous variable of whether there is concordance between what the patient reports and what is in their chart (difference between groups)

  2. Physician rating of decisional conflict [ Time Frame: 8-12 weeks ]
    The decisional conflict scale (DCS) measures personal perceptions of uncertainty in choosing options;modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making. The outcome is the agreement between patient's self-reported preference for life sustaining treatment and decisional conflict using a 5-item decisional conflict scale pre- and post-intervention. Each item is scored 0 to 4 (0=Yes; 1=Probably Yes; 2=Unsure; 3=Probably No; 4=No)

  3. Patient-reported satisfaction with the intervention [ Time Frame: 8-12 weeks ]
    Do patients who participate in an ACP educational intervention experience greater satisfaction with decision-making than patients who get usual care?

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • age 65 years or older
  • have at least one chronic condition that may be life-limiting

Exclusion Criteria:

  • Unable to communicate with an English-speaking research coordinator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03434626

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Canada, Alberta
Family Medical Centre
Lethbridge, Alberta, Canada, T1K 3M5
Chinook Primary Care Network
Lethbridge, Alberta, Canada, T1K 5M5
Sponsors and Collaborators
McMaster University
Queen's University
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Principal Investigator: Michelle Howard, PHD McMaster University
Principal Investigator: Daren K Heyland, MD Queen's University
Publications of Results:

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Responsible Party: McMaster University Identifier: NCT03434626    
Other Study ID Numbers: 06-17
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes