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Randomized Control Trial of Advance Care Planning in Primary Care

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ClinicalTrials.gov Identifier: NCT03239639
Recruitment Status : Completed
First Posted : August 4, 2017
Last Update Posted : February 20, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
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 to think about your 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. There are tools such as brochures, questionnaires, and videos that can help people learn about these things. This research is being to done to study whether using tools for advance care planning and goals of care discussions will improve how patients and their substitute decision makers do advance care planning. This study is a randomized trial. This means half of the people in this study will meet with someone at their family practice to talk about advance care planning and review some tools and half will get usual care (a Speak Up workbook). The study will 1) evaluate if reviewing the tools, and having help to complete them, helps patients and their substitute decision maker do advance care planning 2) if this intervention will encourage patients to talk to their family doctor about these issues.

Condition or disease Intervention/treatment Phase
Chronic Illness Behavioral: Advance care planning education session Other: Wait list control 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. In this project, we aim 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 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 : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned in 1:1 ratio to intervention or wait list control group
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Control Trial of an Advance Care Planning Intervention to Engaged Substitute Decision-makers in Primary Care
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Advance care planning education session
Delivery of an advance care planning education session at the family doctor's office
Behavioral: Advance care planning education session
Administration of values clarification tool, elicitation of preference for treatment options, if preference for resuscitation, shown an educational video about cardiopulmonary resuscitation, summary document of values and preferences created by a facilitator to share with doctor

Sham Comparator: Wait list control
The intervention is not provided.
Other: Wait list control
No intervention




Primary Outcome Measures :
  1. Advance care planning engagement of substitute decision-maker [ Time Frame: 8 to 12 weeks (6 weeks for patients from cancer centre) ]
    A survey of the substitute decision-maker's engagement in advance care planning


Secondary Outcome Measures :
  1. Advance care planning engagement of patient [ Time Frame: 8 to 12 weeks (6 weeks for patients from cancer centre) ]
    A survey of the patient's engagement in advance care planning

  2. Substitute decision-maker self-efficacy survey [ Time Frame: 8 to 12 weeks (6 weeks for patients from cancer centre) ]
    A survey of the substitute decision-maker's confidence to make future decisions

  3. Decisional conflict [ Time Frame: immediately after intervention ]
    A modified short decisional conflict survey

  4. Satisfaction with intervention [ Time Frame: immediately after intervention ]
    A satisfaction and endorsement survey on the process of the educational intervention



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:   No
Criteria

Inclusion Criteria:

  • Patients being treated for serious illness in outpatient settings or;
  • Patients who could benefit from advance care planning self-assessed or assessed by their physician
  • Patient able and willing to identify a substitute decision-maker who will participate in the study
  • Patient cognitively able to participate

Exclusion Criteria:

  • Patient or their substitute decision-maker does not speak English
  • Patient unable to identify a substitute decision-maker who will consent to participation
  • Patient does not consent to participation

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 ClinicalTrials.gov identifier (NCT number): NCT03239639


Locations
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Canada, Ontario
Dundas Family Health Team
Dundas, Ontario, Canada
Michael West Doctor Office
Dundas, Ontario, Canada
Burlington Family Health Team
Hamilton, Ontario, Canada, L7S 0A1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
McMaster Family Health Team
Hamilton, Ontario, Canada, L8P 1H6
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8S 4K1
Juravinski Cancer Centre Pain and Symptom Management Team
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Queen's University
Investigators
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Principal Investigator: Michelle Howard, PhD McMaster University
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03239639    
Other Study ID Numbers: 3714
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: January 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
Keywords provided by McMaster University:
Substitute decision makers of patient
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes